VATSMIPMEP: The Impacts of Pulmonary Rehabilitation Therapy on Patients After Thoracic Surgery

• Sponsor: Chang Gung Memorial Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT02757092
• Collaborator: (none)
• Enrollment: 36
• Locations: 2
• Arms: 2
• Actual Duration (Months): 14
• Patients Per Site: 18
• Patients Per Site Per Month: 1.3

Study Details

Study Description

Brief Summary

The advantages of thoracoscopic surgery include smaller wounds, fewer postoperative complications, and shortened hospital stay. However,complications such as pain, pulmonary function insufficiency, pneumonia,postoperative pneumothorax, persistent air leakage, subcutaneous emphysema, cough, and hemoptysis may occur in older patients after thoracoscopic surgery. Pulmonary rehabilitation has been demonstrated by evidence-base medicine could effectively reduce pulmonary complications and dyspnea as well as improve lung function, quality of life, exercise ability, and functional status of patients after traditional heart and thoracic surgery. Studies have suggested that pulmonary rehabilitation should be performed for at least 4 weeks to optimize the training effect .However, most patients who undergo thoracoscopic surgery were discharged within 3-5 days. Such a short hospital stay impeded the delivery of pulmonary rehabilitation. Home-based pulmonary rehabilitation appeared to be an option for these patients The purpose of this study is to determine whether Pulmonary rehabilitation are effective on patients who had thoracic surgeries.

Condition or Disease	Intervention/Treatment	Phase
Lung Neoplasms	Other: Home-based Pulmonary Rehabilitation	N/A

Detailed Description

Pulmonary-related surgeries remain some potential risks according to the previous evidence-based studies. Particularly, individuals who were over 65 years of age with smoking, chronic pulmonary disease, wheezy, cardiovascular comorbidities, upper respiratory infection were at the high risk of pulmonary complications after surgery,which accounted for approximately 2% to 40% of occurrence rate. The average mortality rate due to surgery was approximately 2%-8% in patients aged more than 65 years.Pulmonary rehabilitation could effectively reduce pulmonary complications and dyspnea as well as improve lung function, quality of life, exercise ability, and functional status of patients after traditional heart and thoracic surgery.But efficacy of home-based pulmonary rehabilitation for older adults following thoracoscopic surgery, it has not received much attention.

This study employed a prospective, randomized, and controlled clinical design to determine the efficacy of home-based pulmonary rehabilitation in older adults after VATS. All participants underwent preoperative and initial postoperative pulmonary rehabilitation during their hospital stay and were randomly assigned to the experimental or control group at the time of discharge. The control group received standard health education, whereas the experimental group received home-based pulmonary rehabilitation in addition to standard health education. Objective and personal subjective outcome measurements were performed before hospital discharge and 2, 6, and 12 weeks after discharge The control group received standard care. Considering the principle for exercise progression, we divided the home-based rehabilitation program into two stages (0-2 weeks and 3-6 weeks).The exercise program was adjusted in the second week when patients visited the outpatient department of the hospital for follow-up. The home-based rehabilitation program included (1) breathing exercises (pursed-lip and diaphragmatic breathing) and coughing exercises, (2) aerobic exercises (upper and lower limb exercises and walking), (3) incentive spirometry training (Triflo-II), and (4) threshold load training of the inspiratory muscle. In the first stage (0-2 weeks), the aerobic exercise intensity was targeted to reach 10-11 points on the 20-point Borg rating of perceived exercise (RPE) scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day. Incentive spirometry training (Triflo-II) was performed 8-10 times per hour. We used a threshold load trainer for inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure.

In the second stage (3-6 weeks), the aerobic exercise intensity was targeted to reach 12-15 points on the RPE scale. Patients performed upper-limb resistance exercise (raising of a 250-cc water bottle) and lower-limb stepping for 20 min per day as well as walking exercise (slow walking for 5 min and fast walking for 2 min, followed by 5-min slow walking, for a total of 30 min). Incentive spirometry training (Triflo-II) was performed 8-10 times per hour, and a threshold load trainer was used to train the inspiratory muscle (30 breaths each time, twice per day), with the pressure intensity adjusted to more than 5% of that in the first stage.Researchers contacted patients at home every week through phone calls to monitor the occurrence of any uncomfortable reaction and to encourage patients to continue their rehabilitation program.

Study Design

• Study Type: Interventional
• Actual Enrollment: 36 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: This study employed a prospective, randomized, and controlled clinical design to determine the efficacy of home-based pulmonary rehabilitation in patients after thoracoscopy. After participants signed the consent form, they were randomly included into the control or experimental group on the day of discharge. The random assignment was performed based on simple randomization by using numbers from 1 to 36; numbered, sealed, opaque envelopes were used for allocation concealment. These envelopes were randomly distributed by non researchers and recorded.This study employed a prospective, randomized, and controlled clinical design to determine the efficacy of home-based pulmonary rehabilitation in patients after thoracoscopy. After participants signed the consent form, they were randomly included into the control or experimental group on the day of discharge. The random assignment was performed based on simple randomization by using numbers from 1 to 36; numbered, sealed, opaque envelopes were used for allocation concealment. These envelopes were randomly distributed by non researchers and recorded.
• Masking: Single (Participant)
• Masking Description: After participants signed the consent form, they were randomly included into the control or experimental group on the day of discharge
• Primary Purpose: Prevention
• Official Title: The Efficacy of Home-Based Pulmonary Rehabilitation Training in Aged Patients With Lung Tumor After Video-assisted Thoracic Surgery:A Clinical Randomized Trial
• Actual Study Start Date: Mar 31, 2016
• Actual Primary Completion Date: Apr 1, 2017
• Actual Study Completion Date: May 31, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Home-based rehabilitation program 0-2 weeks,1. aerobic exercise intensity was targeted to reach 10-11 points of perceived exercise (RPE) scale 2. raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min 3.walked at a comfortable speed for 15 min twice per day.4. Triflo-II was performed 8-10 times per hour. inspiratory muscle training with the initial pressure set at 25%-30% of the maximum inspiratory pressure.3-6 weeks, aerobic exercise reach 12-15 points on the RPE scale. upper-limb resistance exercise (raising of a 250-cc water bottle) and lower-limb stepping for 20 min per day , walking exercise for a total of 30 min. Triflo-II was performed 8-10 times per hour, and train the inspiratory muscle with the pressure intensity adjusted to more than 5% of that in the first stage.	Other: Home-based Pulmonary Rehabilitation; (1) breathing exercises (pursed-lip and diaphragmatic breathing) and coughing exercises, (2) aerobic exercises (upper and lower limb exercises and walking), (3) incentive spirometry training (Triflo-II), and (4) threshold load training of the inspiratory muscle. In the first stage (0-2 weeks), the aerobic exercise intensity was targeted to reach 10-11 points on the 20-point Borg rating of perceived exercise (RPE) scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day. Incentive spirometry training (Triflo-II) was performed 8-10 times per hour. We used a threshold load trainer for inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure.
Active Comparator: standard care control group accept the pulmonary rehabilitation (breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy and pain control) only in operation stage on before op-day 3 day and after op-day and without home based pulmonary rehabilitation.	Other: Home-based Pulmonary Rehabilitation; (1) breathing exercises (pursed-lip and diaphragmatic breathing) and coughing exercises, (2) aerobic exercises (upper and lower limb exercises and walking), (3) incentive spirometry training (Triflo-II), and (4) threshold load training of the inspiratory muscle. In the first stage (0-2 weeks), the aerobic exercise intensity was targeted to reach 10-11 points on the 20-point Borg rating of perceived exercise (RPE) scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day. Incentive spirometry training (Triflo-II) was performed 8-10 times per hour. We used a threshold load trainer for inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure.

Outcome Measures

Primary Outcome Measures

1. Discharge 2weeks Exercise Capacity [assessed at discharge 2weeks]

   Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome.

2. Discharge 6 Weeks Exercise Capacity [assessed at discharge.6weeks]

   Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome.

3. Discharge 12 Weeks Exercise Capacity [assessed at discharge 12 weeks]

   Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M).higher scores mean a better outcome.

Secondary Outcome Measures

1. Discharge 2 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec) [assessments at 2 weeks after discharge]

   Forced vital capacity (FVC in L/sec) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 L/sec,and for females from 3.25-2.5 L/sec ,and whether higher scores mean a better outcome.

2. Discharge 2weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec) [assessed at 2 weeks after discharge]

   The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome.

3. Discharge 2weeks MMEF 25-75%(Liter(L)/Sec) [assessed at discharge 2weeks]

   Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome.

4. Discharge 2weeks Peak Expiratory Flow Rate(PEFR , Liter(L)/Sec) [assessed at discharge 2weeks]

   Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome.

5. Discharge 2weeks Inspiratory Muscle Strength(MIP,cmH2O) [assessed at discharge 2 weeks.]

   Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome.

6. Discharge 2weeks Expiratory Muscle Strength(MEP,cmH2O) [assessed at discharge 2 weeks]

   The Maximal Expiratory Pressure (MEP) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cmH2O is always abnormal, and higher scores mean a better outcome.

7. Discharge 2 Weeks Modified Borg Score [assessed at discharge 2 weeks]

   Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome

8. Discharge 2weeks Lung Expansion Capacity [assessed at discharge 2 weeks]

   Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (ml).higher scores mean a better outcome.

9. Postoperative 2 Weeks Pulmonary Complications [at 2weeks after discharge]

   Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18.

10. Discharge 6 Weeks Forced Vital Capacity(Liter(L)/Sec) [assessments at discharge 6 weeks]

    Forced vital capacity (FVC in (liter(L)/sec)) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 (liter(L)/sec),and for females from 3.25-2.5 (liter(L)/sec) ,and whether higher scores mean a better outcome.

11. Discharge 6 Weeks Forced Expiratory Volume in 1 Second (FEV1,Liter(L)/Sec) [assessed at discharge 6weeks]

    The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome.

12. Discharge 6weeks MMEF 25-75%(Liter(L)/Sec) [assessed at discharge 6 weeks]

    Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome.

13. Discharge 6weeks Peak Expiratory Flow Rate(PEFR in Liter( L)/Sec) [assessed at discharge .6weeks]

    Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome.

14. Discharge 6 Weeks Inspiratory Muscle Strength(MIP,cmH2O) [assessed at discharge6 weeks.]

    Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome.

15. Discharge 6weeks Expiratory Muscle Strength (MEP, cmH2O) [assessed at discharge 6 weeks]

    The Maximal Expiratory Pressure (MEP,cmH2O) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cm H2O is always abnormal, and higher scores mean a better outcome.

16. Discharge 6 Weeks Modified Borg Score [assessed at discharge 6week]

    Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome

17. Discharge 6weeks Lung Expansion Capacity [assessed at discharge 6 weeks]

    Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml)).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (mL)c.higher scores mean a better outcome.

18. Postoperative 6weeks Pulmonary Complications [at 6weeks after discharge]

    Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.In our research,some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18.

19. Discharge 12 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec ) [assessments at discharge 12 weeks]

    Forced vital capacity (FVC in (liter(L)/sec)) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 (liter(L)/sec),and for females from 3.25-2.5 (liter(L)/sec) ,and whether higher scores mean a better outcome.

20. Discharge 12 Weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec) [assessed at discharge12weeks]

    The Forced Expiratory Volume in 1 Second parameter(FEV1,liter(L)/sec) measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome.

21. Discharge 12 Weeks MMEF 25-75%(Liter(L)/Sec) [assessed at discharge12weeks "]

    Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome.

22. Discharge 12 Weeks Peak Expiratory Flow Rate (PEFR in Liter(L)/Sec) [assessed at discharge 12 weeks]

    Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome.

23. Discharge 12 Weeks Inspiratory Muscle Strength (MIP,cmH2O) [assessed at discharge12 weeks.]

    Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome.

24. Discharge 12weeks Expiratory Muscle Strength(MEP,cmH2O) [assessed at discharge 12weeks]

    The Maximal Expiratory Pressure (MEP,cmH2O) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cm H2O is always abnormal, and higher scores mean a better outcome.

25. Discharge 12 Weeks Modified Borg Score [assessed at discharge12weeks]

    Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome

26. Discharge 12 Weeks Lung Expansion Capacity [assessed at discharge 12weeks]

    Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml)).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (mL)c.higher scores mean a better outcome.

27. Postoperative 12 Weeks Pulmonary Complications [at 12 weeks after discharge]

    Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 65 Years to 85 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Signed consent

2. The men and women over the age of 65

3. admission to undergo VATS.

4. consciousness and ability to communicate

5. ability to undergo 6 weeks of a home-based pulmonary rehabilitation program

Exclusion Criteria:

1. refusal to participate

2. unplanned emergency surgery

3. hemodynamic instability

4. received other surgery within a month postsurgery

5. unconsciousness after surgery

6. bedridden and upper or lower limb weakness

7. received radiation and chemotherapy postsurgery

8. implementation of thoracoscopic surgery for biopsy only

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Chang Gung Memorial Hospital	Kaohsiung	Niaosong	Taiwan	83342
2	Chang Gung Memorial Hospital	Kaohsiung		Taiwan	83342

Sponsors and Collaborators

• Chang Gung Memorial Hospital

Investigators

• Study Director: Jui Fang Liu, PhD, Department of Respiratory Therapy
• Study Chair: Nai Ying Kuo, master, Department of Respiratory Therapy

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 31, 2016

More Information

Publications

None provided.

• Responsible Party: Liu Jui Fang, Respiratory therapist, Chang Gung Memorial Hospital
• ClinicalTrials.gov Identifier: NCT02757092
• Other Study ID Numbers: 1046659A3
• First Posted: Apr 29, 2016
• Last Update Posted: Nov 3, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Keywords provided by Liu Jui Fang, Respiratory therapist, Chang Gung Memorial Hospital: Pulmonary rehabilitation; surgery; exercise
• Additional relevant MeSH terms: Lung Neoplasms

Study Results

Participant Flow

Recruitment Details	The study was design a Prospective randomized control trial,and enrolled a total of 36 older patients with lung tumors after thoracoscopic surgery in the cardiothoracic and vascular ordinary ward between March 31 2016 to April 1 2017. The study was performed conducted in Kaohsiung Chang Gung Memorial Hospital, Taiwan

Arm/Group Title	Home Pulmonary Rehabilitation Group	Study Group
Arm/Group Description	Pulmonary Rehabilitation group accept the pulmonary rehabilitation( breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy ) in operation stage on before op-day 3 day and after op-day 2 weeks and keep home based pulmonary rehabilitation on discharge 2 weeks, 6 weeks and after 12 weeks. study group : received pain medication and standard care	study group accept the pulmonary rehabilitation( breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy ) in operation stage on before op-day 3 day and after op-day ,after discharged received standard care
Period Title: Overall Study
STARTED	18	18
COMPLETED	18	18
NOT COMPLETED	0	0

Baseline Characteristics

Arm/Group Title	Pulmonary Rehabilitation Group	The Control Group	Total
Arm/Group Description	arm group accept the pulmonary rehabilitation( smoking cession before operation, breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy and pain control) in operation stage on before op-day 3 day and after op-day 2 weeks and keep home based pulmonary rehabilitation on discharge 2 weeks, 6 weeks and after 12 weeks.	The control group received pain medication and usual care.	Total of all reporting groups
Overall Participants	18	18	36
Age (Count of Participants)
<=18 years	0 0%	0 0%	0 0%
Between 18 and 65 years	0 0%	0 0%	0 0%
>=65 years	18 100%	18 100%	36 100%
Sex: Female, Male (Count of Participants)
Female	8 44.4%	11 61.1%	19 52.8%
Male	10 55.6%	7 38.9%	17 47.2%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (Count of Participants)
Taiwan	18 100%	18 100%	36 100%
BMI (Kg/m2) (Kg/m2) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Kg/m2]	25.08 (3.3)	23.46 (2.8)	24.27 (3.05)
BW (kg) (kg) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg]	65.33 (11.71)	57.98 (9.44)	61.66 (10.57)
Amount of comorbidities (Count of Participants)
Hypertension	7 38.9%	11 61.1%	18 50%
DM	5 27.8%	4 22.2%	9 25%
Cardiovascular diseases n	2 11.1%	4 22.2%	6 16.7%
COPD	9 50%	2 11.1%	11 30.6%
smoking (Count of Participants)
Count of Participants [Participants]	6 33.3%	4 22.2%	10 27.8%
total hospital days (days) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [days]	8.68 (4.41)	8.32 (3.28)	8.5 (3.85)
PFT (liter/sec) [Mean (Standard Deviation) ]
FEV1(liter/sec)	1.88 (0.44)	1.78 (0.93)	1.83 (0.69)
FVC(liter/sec)	1.48 (0.47)	1.43 (0.71)	1.45 (0.59)
MMEF25-75(liter/sec)	1.80 (1.17)	1.41 (0.77)	1.61 (0.97)
PEFR(liter/sec)	4.08 (2.05)	3.01 (1.46)	3.55 (1.76)
FEV1/FVC(%) (%) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [%]	79.02 (17.01)	81.03 (10.45)	80.03 (13.73)
Modified Borg score (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	1.61 (0.6)	1.89 (0.58)	1.75 (0.59)
MIP(cmH2O) (cmH2O) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cmH2O]	50.22 (11.89)	49.73 (16.83)	49.98 (13.82)
MEP(cmH2O) (cmH20) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [cmH20]	61.89 (24.00)	50.40 (21.06)	56.15 (23.36)
Lung capacity (mL/sec) (mL) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [mL]	1200.00 (534.68)	1000.00 (524.68)	1100.00 (529.68)
6-min walk test(meter,M) (meter) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [meter]	364.33 (49.89)	315.22 (59.34)	339.78 (54.62)
Anesthesia time(min) (min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [min]	271.15 (83.52)	249.84 (70.83)	260.5 (77.18)
American Society of Anesthesiologists (ASA) score (scores on a scale) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [scores on a scale]	2.11 (0.32)	2.11 (0.58)	2.11 (0.45)
Surgery time(min) (min) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [min]	236.90 (79.02)	225.26 (66.32)	231.08 (72.67)
chest tube placement time(hours) (hours) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [hours]	115.05 (37.56)	118.11 (50.90)	116.58 (44.23)
surgery method (Count of Participants)
lobectomy	11 61.1%	12 66.7%	23 63.9%
wedge resection	5 27.8%	5 27.8%	10 27.8%
sefmentectomy	2 11.1%	1 5.6%	3 8.3%
wedge resection (Count of Participants)
Count of Participants [Participants]	5 27.8%	5 27.8%	10 27.8%
surgery site (Count of Participants)
Right upper lobe	12 66.7%	7 38.9%	19 52.8%
Right middle lobe	1 5.6%	1 5.6%	2 5.6%
Right low lobe	3 16.7%	4 22.2%	7 19.4%
left upper lobe	0 0%	5 27.8%	5 13.9%
left low lobe	3 16.7%	1 5.6%	4 11.1%
postoperative diagnosis (Count of Participants)
small cell carcinoma	1 5.6%	0 0%	1 2.8%
adenocarcinoma	14 77.8%	13 72.2%	27 75%
large cell carcinoma	1 5.6%	0 0%	1 2.8%
sguamous cell carcinoma	0 0%	3 16.7%	3 8.3%
benign lung tumor	2 11.1%	2 11.1%	4 11.1%
postoperative stages of lung cancer (Count of Participants)
stage1 n(%)	11 61.1%	8 44.4%	19 52.8%
stage2 n(%)	4 22.2%	7 38.9%	11 30.6%
Benign lung tumor(%)	2 11.1%	2 11.1%	4 11.1%
others,ground-glass opacity(%)	1 5.6%	1 5.6%	2 5.6%
postoperative complications (Count of Participants)
emphysema	16 88.9%	15 83.3%	31 86.1%
air leak	6 33.3%	6 33.3%	12 33.3%

Outcome Measures

1. Primary Outcome

Title	Discharge 2weeks Exercise Capacity
Description	Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome.
Time Frame	assessed at discharge 2weeks

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for exercise capacity.an intention-to-treat analysis was performed.group × time interactions were observed for the 6-min walking distance.

Arm/Group Title	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc	The Control Group 2weeks Six-min Walking Distanc
Arm/Group Description	Each subject received six-min walking distance assessments at discharge 2 weeks after discharge	Each subject received six-min walking distance assessments at discharge 2 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [meter(M)]	408.61 (62.85)	311.94 (84.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

2. Primary Outcome

Title	Discharge 6 Weeks Exercise Capacity
Description	Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M)higher scores mean a better outcome.
Time Frame	assessed at discharge.6weeks

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for exercise capacity. For group comparisons, an intention-to-treat analysis was performed.group × time interactions were observed for the 6-min walking distance.

Arm/Group Title	Pulmonary Rehabilitation Group 6 Weeks Six-min Walking Distanc	The Control Group 6 Weeks Six-min Walking Distanc
Arm/Group Description	Each subject received six-min walking distance assessments at 6 weeks after discharge	Each subject received six-min walking distance assessments at discharge6 weeks, after discharge
Measure Participants	18	18
Mean (Standard Deviation) [meter(M)]	411.63 (44.49)	332.94 (54.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments	null hypothesis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

3. Primary Outcome

Title	Discharge 12 Weeks Exercise Capacity
Description	Exercise capacity as assessed by 6 min walking test(M).The 6-min walk test (6 MWT) is a submaximal exercise test that entails measurement of distance walked over a span of 6 minutes. The 6-minute walk distance (6 MWD) provides a measure for integrated global response of multiple cardiopulmonary and musculoskeletal systems involved in exercise . The 6 MWT provides information regarding functional capacity, response to therapy and prognosis across a broad range of chronic cardiopulmonary conditions .The normal range in aged patients 60-69 y(male 572 m,female 538 M),70-79 y(male 527 m,female 471 M),80-89 y(male 417 m,female 392 M).higher scores mean a better outcome.
Time Frame	assessed at discharge 12 weeks

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for exercise capacity. For group comparisons, an intention-to-treat analysis was performed. group × time interactions were observed for the 6-min walking distance.

Arm/Group Title	Pulmonary Rehabilitation group12 Weeks Six-min Walking Distanc	The Control Group 12 Weeks Six-min Walking Distanc
Arm/Group Description	Each subject received six-min walking distance assessments at discharge 12 weeks after discharge	Each subject received six-min walking distance assessments at discharge 12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [meter(M)]	397.06 (50.37)	345.17 (46.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

4. Secondary Outcome

Title	Discharge 2 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec)
Description	Forced vital capacity (FVC in L/sec) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 L/sec,and for females from 3.25-2.5 L/sec ,and whether higher scores mean a better outcome.
Time Frame	assessments at 2 weeks after discharge

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group 2 Weeks FVC (Liter(L)/Sec)	The Control Group 2 Weeks FVC(Liter(L)/Sec))
Arm/Group Description	Each subject received FVC assessments at 2 weeks after discharge	Each subject received FVC assessments at 2 weeks discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter(L)/sec]	2.48 (0.80)	2.00 (0.85)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

5. Secondary Outcome

Title	Discharge 2weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec)
Description	The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome.
Time Frame	assessed at 2 weeks after discharge

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group 2 Weeks FEV1 (Liter(L)/Sec)	The Control Group 2 Weeks FEV1(Liter(L)/Sec)
Arm/Group Description	Each subject received FEV1 (liter(L)/sec)assessments at 2 weeks after discharge	Each subject received FEV1(liter(L)/sec) assessments at 2 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter(L)/sec]	1.97 (0.54)	1.57 (0.69)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

6. Secondary Outcome

Title	Discharge 2weeks MMEF 25-75%(Liter(L)/Sec)
Description	Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome.
Time Frame	assessed at discharge 2weeks

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group	The Control Group
Arm/Group Description	Each subject received MMEF25-75%(liter(L)/sec) assessments at 2 weeks after discharge	Each subject received MMEF25-75%(liter(L)/sec) assessments at 2 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter(L)/sec]	2.00 (0.81)	1.58 (0.94)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments	null hypothesis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

7. Secondary Outcome

Title	Discharge 2weeks Peak Expiratory Flow Rate(PEFR , Liter(L)/Sec)
Description	Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome.
Time Frame	assessed at discharge 2weeks

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group	The Control Group
Arm/Group Description	Each subject received PEFR assessments at 2 weeks after discharge	Each subject received PEFR assessments at 2 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter(L)/sec]	5.68 (2.35)	4.27 (2.35)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments	null hypothesis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

8. Secondary Outcome

Title	Discharge 2weeks Inspiratory Muscle Strength(MIP,cmH2O)
Description	Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome.
Time Frame	assessed at discharge 2 weeks.

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for MIP. For group comparisons, an intention-to-treat analysis was performed. group × time interactions were observed for the MIP

Arm/Group Title	Pulmonary Rehabilitation Group 2 Weeks MIP(cmH2O)	The Control Group 2weeks MIP (cmH2O)
Arm/Group Description	Each subject received MIP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge	Each subject received MIP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [cmH2O]	90.00 (25.66)	67.33 (28.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

9. Secondary Outcome

Title	Discharge 2weeks Expiratory Muscle Strength(MEP,cmH2O)
Description	The Maximal Expiratory Pressure (MEP) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cmH2O is always abnormal, and higher scores mean a better outcome.
Time Frame	assessed at discharge 2 weeks

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for MEP. an intention-to-treat analysis was performed.group × time interactions were observed for the MEP

Arm/Group Title	Pulmonary Rehabilitation Group 2 Weeks MEP(cmH2O)	The Control Group 2weeks MEP(cmH2O)
Arm/Group Description	Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge	Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [cmH2O]	89.44 (28.79)	68.89 (22.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

10. Secondary Outcome

Title	Discharge 2 Weeks Modified Borg Score
Description	Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome
Time Frame	assessed at discharge 2 weeks

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for Modified Borg score.an intention-to-treat analysis was performed.group × time interactions were observed for the Modified Borg score

Arm/Group Title	Pulmonary Rehabilitation Group 2 weeksModified Borg Score	The Control Group 2weeks Modified Borg Score
Arm/Group Description	Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge	Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [scores on a scale]	1.06 (0.54)	1.72 (0.67)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

11. Secondary Outcome

Title	Discharge 2weeks Lung Expansion Capacity
Description	Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (ml).higher scores mean a better outcome.
Time Frame	assessed at discharge 2 weeks

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for Lung expansion capacity. an intention-to-treat analysis was performed.group × time interactions were observed for the Lung expansion capacity.

Arm/Group Title	Pulmonary Rehabilitation	Control Group
Arm/Group Description	study group follow Triflo on discharge 2 weeks	control group follow Triflo on discharge 2 weeks
Measure Participants	18	18
Mean (Standard Deviation) [(ml)]	1450.00 (619.53)	1033.33 (388.65)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

12. Secondary Outcome

Title	Postoperative 2 Weeks Pulmonary Complications
Description	Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18.
Time Frame	at 2weeks after discharge

Outcome Measure Data

Analysis Population Description

Pearson chi-square test was used for Pulmonary complication on discharge 2 weeks .Data is presented as either n(%).

Arm/Group Title	Pulmonary Rehabilitation	Control Group
Arm/Group Description	study group follow CXR on discharge 2 weeks	control group follow CXR on discharge 2 weeks
Measure Participants	18	18
pneumonia	0 0%	1 5.6%
atelectasis	1 5.6%	2 11.1%
pleural effusion	0 0%	1 5.6%
emphysema	0 0%	1 5.6%
pulmonary infilation	1 5.6%	0 0%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments	Descriptive statistics were expressed as mean ± standard deviation or median and interquartile range depending on the nature and distribution of the variables
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.05
	Comments
	Method	Chi-squared
	Comments

13. Secondary Outcome

Title	Discharge 6 Weeks Forced Vital Capacity(Liter(L)/Sec)
Description	Forced vital capacity (FVC in (liter(L)/sec)) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 (liter(L)/sec),and for females from 3.25-2.5 (liter(L)/sec) ,and whether higher scores mean a better outcome.
Time Frame	assessments at discharge 6 weeks

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group 6 Weeks FVC(Liter(L)/Sec)	The Control Group 6 Weeks FVC (Liter(L)/Sec)
Arm/Group Description	Each subject received (FVC in liter(L)/sec) assessments at 6 weeks after discharge	Each subject received FVC assessments at 6 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter( L)/sec]	2.48 (0.88)	1.97 (0.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments	null hypothesis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

14. Secondary Outcome

Title	Discharge 6 Weeks Forced Expiratory Volume in 1 Second (FEV1,Liter(L)/Sec)
Description	The Forced Expiratory Volume in 1 Second parameter measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome.
Time Frame	assessed at discharge 6weeks

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group 6 Weeks FEV1,Liter(L)/Sec	The Control Group 6 Weeks FEV1,Liter(L)/Sec
Arm/Group Description	Each subject received FEV1 assessments at discharge 6 weeks after discharge	Each subject received FEV1 assessments at discharge 6 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter(L)/sec]	2.02 (0.60)	1.58 (0.62)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

15. Secondary Outcome

Title	Discharge 6weeks MMEF 25-75%(Liter(L)/Sec)
Description	Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome.
Time Frame	assessed at discharge 6 weeks

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group 6 Weeks MMEF(Liter(L)/Sec)	The Control Group 6 Weeks MMEF(Liter(L)/Sec)
Arm/Group Description	Each subject received MMEF assessments at 6 weeks after discharge	Each subject received MMEF assessments at 6 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter(L)/sec]	2.12 (0.74)	2.08 (1.46)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

16. Secondary Outcome

Title	Discharge 6weeks Peak Expiratory Flow Rate(PEFR in Liter( L)/Sec)
Description	Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome.
Time Frame	assessed at discharge .6weeks

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group	The Control Group
Arm/Group Description	Each subject received PEFRassessments at 6 week after discharge	Each subject received PEFR assessments at 6 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter(L)/sec]	5.13 (1.50)	4.71 (2.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments	null hypothesis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

17. Secondary Outcome

Title	Discharge 6 Weeks Inspiratory Muscle Strength(MIP,cmH2O)
Description	Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome.
Time Frame	assessed at discharge6 weeks.

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for MIP. an intention-to-treat analysis was performed.group × time interactions were observed for the MIP

Arm/Group Title	Pulmonary Rehabilitation Group MIP(cmH2O)	The Control Group MIP(cmH2O)
Arm/Group Description	Each subject received MIP assessments at discharge 6 weeks	Each subject received MIP assessments at discharge 6 weeks
Measure Participants	18	18
Mean (Standard Deviation) [cmH2O]	93.33 (34.47)	64.67 (20.3)

18. Secondary Outcome

Title	Discharge 6weeks Expiratory Muscle Strength (MEP, cmH2O)
Description	The Maximal Expiratory Pressure (MEP,cmH2O) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cm H2O is always abnormal, and higher scores mean a better outcome.
Time Frame	assessed at discharge 6 weeks

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for MEP. an intention-to-treat analysis was performed.group × time interactions were observed for the MEP

Arm/Group Title	Pulmonary Rehabilitation Group 6 Weeks MEP(cmH2O)	The Control Group 6 Weeks MEP(cmH2O)
Arm/Group Description	Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge	Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [cmH2O]	93.89 (30.70)	76.67 (23.51)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

19. Secondary Outcome

Title	Discharge 6 Weeks Modified Borg Score
Description	Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome
Time Frame	assessed at discharge 6week

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for Modified Borg score.an intention-to-treat analysis was performed.group × time interactions were observed for the Modified Borg score

Arm/Group Title	Pulmonary Rehabilitation Group 6 weeksModified Borg Score	The Control Group 6 Weeks Modified Borg Score
Arm/Group Description	Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge	Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [scores on a scale]	0.75 (0.79)	1.11 (1.74)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

20. Secondary Outcome

Title	Discharge 6weeks Lung Expansion Capacity
Description	Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml)).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (mL)c.higher scores mean a better outcome.
Time Frame	assessed at discharge 6 weeks

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for Lung expansion capacity. an intention-to-treat analysis was performed.group × time interactions were observed for the Lung expansion capacity

Arm/Group Title	Pulmonary Rehabilitation	Control Group
Arm/Group Description	study group follow incentive spirometry with the flow-oriented device( Triflow II,(cc/sec) on discharge 6 weeks	control group follow incentive spirometry with the flow-oriented device( Triflow II,(cc/sec) on discharge 6 weeks
Measure Participants	18	18
Mean (Standard Deviation) [(ml)]	1683.33 (667.96)	1116.63 (382.33)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

21. Secondary Outcome

Title	Postoperative 6weeks Pulmonary Complications
Description	Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.In our research,some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18.
Time Frame	at 6weeks after discharge

Outcome Measure Data

Analysis Population Description

Pearson chi-square test was used for Pulmonary complication on discharge 6 weeks .Data is presented as n(%).

Arm/Group Title	Pulmonary Rehabilitation	Control Group
Arm/Group Description	study group follow CXR on discharge 6 weeks	control group follow CXR on discharge 6 weeks
Measure Participants	18	18
pneumonia	0 0%	1 5.6%
atelectasis	0 0%	2 11.1%
pleural effusion	3 16.7%	4 22.2%
emphysema	5 27.8%	11 61.1%
pulmonary infilation	1 5.6%	1 5.6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments	null hypothesis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	Chi-squared
	Comments

22. Secondary Outcome

Title	Discharge 12 Weeks Forced Vital Capacity (FVC in Liter(L)/Sec )
Description	Forced vital capacity (FVC in (liter(L)/sec)) assessment by pulmonary function test.Normal values in healthy males aged 20-60 from 4.5-3.5 (liter(L)/sec),and for females from 3.25-2.5 (liter(L)/sec) ,and whether higher scores mean a better outcome.
Time Frame	assessments at discharge 12 weeks

Outcome Measure Data

Analysis Population Description

.2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group	The Control Group
Arm/Group Description	Each subject received FVC(L/sec) assessments at 12 weeks after discharge	Each subject received FVC(L/sec) assessments at 12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter( L)/sec]	2.32 (0.72)	2.16 (0.96)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments	null hypothesis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

23. Secondary Outcome

Title	Discharge 12 Weeks Forced Expiratory Volume in 1 Second(FEV1,Liter(L)/Sec)
Description	The Forced Expiratory Volume in 1 Second parameter(FEV1,liter(L)/sec) measures the volume of air that was exhaled into the mouthpiece in the first second after a full inhalation. The Measured column represents the total volume exhaled during the first second, in liters. Normal values in healthy males aged 20-60 range from 4.5 to 3.5 liters, and normal values for females aged 20-60 range from 3.25 to 2.5 liters. The Predicted column compares the actual volume breathed out during the first second of your test to an average of the normal volume breathed out in 1 second for a person of the same gender, height, and age. This value is expressed as a percentage, with normal test values being between 80% and 120% of the average (predicted) values.and whether higher scores mean a better outcome.
Time Frame	assessed at discharge12weeks

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group 12 Weeks FEV1,Liter(L)/Sec	The Control Group 12 Weeks FEV1,Liter(L)/Sec
Arm/Group Description	Each subject received FEV1 assessments at discharge12 weeks after discharge	Each subject received FEV1 assessments at discharge12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter(L)/sec]	1.85 (0.45)	1.74 (0.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments	null hypothesis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

24. Secondary Outcome

Title	Discharge 12 Weeks MMEF 25-75%(Liter(L)/Sec)
Description	Forced expiratory flow (FEF) is the flow (or speed) of air coming out of the lung during the middle portion of a forced expiration. It can be given at discrete times, generally defined by what fraction of the forced vital capacity (FVC) has been exhaled. The usual discrete intervals are 25%, 50% and 75%, usually 25-75% (FEF25-75%).Predicted normal values for FEF depend on age, sex, height, mass and ethnicity as well as the research study that they are based on assessment by pulmonary function test and higher scores mean a better outcome.
Time Frame	assessed at discharge12weeks "

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group 12weeks MMEF(Liter(L)/Sec)	The Control Group 12 Weeks MMEF(Liter(L)/Sec)
Arm/Group Description	Each subject received MMEF assessments at 12 weeks after discharge	Each subject received MMEF assessments at 12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter(L)/sec]	2.44 (1.50)	1.85 (0.76)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

25. Secondary Outcome

Title	Discharge 12 Weeks Peak Expiratory Flow Rate (PEFR in Liter(L)/Sec)
Description	Peak expiratory flow rate (PEFR in liter(L)/sec) assessment by pulmonary function test.It measures the airflow through the bronchi and thus the degree of obstruction in the airways. Peak expiratory flow is typically measured in units of liters per second (L/sec).when measured as part of spirometry.The normal range 500-700 L/sec In men, for women, the normal range is 380-500 L/sec.higher scores mean a better outcome.
Time Frame	assessed at discharge 12 weeks

Outcome Measure Data

Analysis Population Description

2-WAY repeated measures ANOVA method was used for pulmonary function test.

Arm/Group Title	Pulmonary Rehabilitation Group	The Control Group
Arm/Group Description	Each subject received PEFR assessments at 12 weeks after discharge	Each subject received PEFR assessments at 12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [liter(L)/sec]	4.94 (1.46)	4.78 (2.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments	null hypothesis
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

26. Secondary Outcome

Title	Discharge 12 Weeks Inspiratory Muscle Strength (MIP,cmH2O)
Description	Inspiratory muscle strength as assessed by Maximum inspiratory pressure (MIP, cmH2O).The MIP is a measure of inspiratory muscle strength produced by a sub-atmospheric pressure The normal.range of MIP in elderly people approximately 60 cm H2O for men and 40 cm H2O for women .An absolute MIP value of < - 40 cm H2O is always abnormal,and higher scores was mean a better outcome.
Time Frame	assessed at discharge12 weeks.

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for MIP. an intention-to-treat analysis was performed.group × time interactions were observed for the MIP

Arm/Group Title	Pulmonary Rehabilitation Group	The Control Group(MIP,cmH2O)
Arm/Group Description	Each subject received MIP assessments at discharge 12 weeks	Each subject received MIP assessments at discharge 12 weeks
Measure Participants	18	18
Mean (Standard Deviation) [cmH2O]	91.11 (30.46)	64.67 (20.30)

27. Secondary Outcome

Title	Discharge 12weeks Expiratory Muscle Strength(MEP,cmH2O)
Description	The Maximal Expiratory Pressure (MEP,cmH2O) are global measures of the maximal strength of the respiratory muscles.(MEP, cmH2O) .MEP is a supra-atmospheric pressure which can be developed in an effort of the abdominal and intercostal muscles.Expiratory muscle strength assesses extrathoracic muscle health.An absolute MEP value of < 80 cm H2O is always abnormal, and higher scores mean a better outcome.
Time Frame	assessed at discharge 12weeks

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for MEP. an intention-to-treat analysis was performed.group × time interactions were observed for the MEP

Arm/Group Title	Pulmonary Rehabilitation Group 12 Weeks MEP(cmH2O)	The Control Group 12 Weeks MEP(cmH2O)
Arm/Group Description	Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge	Each subject received MEP assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [cmH2O]	92.56 (34.37)	74.48 (18.64)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

28. Secondary Outcome

Title	Discharge 12 Weeks Modified Borg Score
Description	Dyspnea score as assessed by Modified Borg score, The literature review clearly showed that the Modified Borg score was a valid and reliable tool when used in pulmonary medicine and in exercise physiology studies.The scale used was perceived exertion adapted to be appropriate for measuring dyspnea. This consisted of a vertical scale labelled 0-10, with corresponding verbal expressions of progressively increasing perceived sensation intensity. It starts at number 0 that mean breathing is no difficulty at all and progresses through to number 10 that mean breathing difficulty is maximal.so higher scores mean a worse outcome
Time Frame	assessed at discharge12weeks

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for Modified Borg score. an intention-to-treat analysis was performed.group × time interactions were observed for the Modified Borg score

Arm/Group Title	Pulmonary Rehabilitation Group 12weeksModified Borg Score	The Control Group 12 Weeks Modified Borg Score
Arm/Group Description	Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge	Each subject received Modified Borg score assessments at discharge, and 2 weeks, 6 weeks, and 12 weeks after discharge
Measure Participants	18	18
Mean (Standard Deviation) [scores on a scale]	0.70 (0.83)	1.05 (0.92)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

29. Secondary Outcome

Title	Discharge 12 Weeks Lung Expansion Capacity
Description	Lung expansion capacity as assessed by incentive spirometry with the flow-oriented device( Triflow II,volume × seconds) (ml)).Incentive spirometry that feedback respiratory training can improve respiratory function, endurance for exercise capacity,Wide flow rate range from 600 - 1200(volume × seconds) (mL)c.higher scores mean a better outcome.
Time Frame	assessed at discharge 12weeks

Outcome Measure Data

Analysis Population Description

Two-way repeated measures ANOVA for Lung expansion capacity. an intention-to-treat analysis was performed.group × time interactions were observed for the Lung expansion capacity

Arm/Group Title	Pulmonary Rehabilitation	Control Group
Arm/Group Description	study group follow incentive spirometry with the flow-oriented device( Triflow II,(cc/sec) on discharge12 weeks	control group follow incentive spirometry with the flow-oriented device( Triflow II,(cc/sec) on discharge12 weeks
Measure Participants	18	18
Mean (Standard Deviation) [(ml)]	1406.67 (798.20)	1150.33 (345.13)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Pulmonary Rehabilitation Group 2 Weeks Six-min Walking Distanc, The Control Group 2weeks Six-min Walking Distanc
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments
	Method	ANOVA
	Comments

30. Secondary Outcome

Title	Postoperative 12 Weeks Pulmonary Complications
Description	Pulmonary complication as assessed by Chest X-ray.pneumonia.lung collapse.atelectasis.emphysema and pleural effusion were collected.some patients have two pulmonary complications at the same time, such as emphysem and infiltration, so the total number is not necessarily equal to 18.
Time Frame	at 12 weeks after discharge

Outcome Measure Data

Analysis Population Description

Pearson chi-square test was used for Pulmonary complication on discharge 12 weeks .Data is presented as n(%).

Arm/Group Title	Pulmonary Rehabilitation	Control Group
Arm/Group Description	study group follow CXR on discharge12 weeks	control group follow CXR on discharge 12 weeks
Measure Participants	18	18
pneumonia	0 0%	1 5.6%
atelectasis	1 5.6%	2 11.1%
pleural effusion	0 0%	1 5.6%
emphysema	1 5.6%	0 0%
pulmonary infilation	0 0%	1 5.6%

Adverse Events

Time Frame	we collect 12 weeks of adverse event data
Adverse Event Reporting Description	Before discharge,If air leakage occurs before discharge, we definition it as an adverse event, because it may extend the patient's hospital stay.After discharge, home-based rehabilitation program design as a low-to-medium intensity and non-invasive .Researchers contacted patients at home every week through phone calls to monitor the occurrence of any uncomfortable reaction and post-op 2weeks,6weeks and 12weeks regular check CXR .PFT. 6min walking test and respiratory muscle power .
Arm/Group Title	Pulmonary Rehabilitation Group		The Control Group
Arm/Group Description	0-2 weeks, the aerobic exercise intensity was targeted to reach 10-11 points of RPE scale. Patients raised their upper limbs while simultaneously performing lower-limb stepping at place for 20 min; in addition, they walked at a comfortable speed for 15 min twice per day.Triflo-II was performed 8-10 times per hour. inspiratory muscle training (30 breaths each time, twice per day) with the initial pressure set at 25%-30% of the maximum inspiratory pressure. 3-6 weeks, the aerobic exercise intensity was targeted to reach 12-15 points on the RPE scale. Patients performed upper-limb resistance exercise (raising of a 250-cc water bottle) and lower-limb stepping for 20 min per day as well as walking exercise (slow walking for 5 min and fast walking for 2 min, followed by 5-min slow walking, for a total of 30 min).Triflo-II was performed 8-10 times per hour, and inspiratory muscle training, with the pressure intensity adjusted to more than 5% of that in the first stage.		The control group accept the pulmonary rehabilitation , breathing exercise, extremities exercise, breathing muscle training, incentive spirometry (Triflo-II) training, intermittent positive pressure ventilation, chest physical therapy and pain control) only in operation stage on before op-day 3 day and after op-day and without home based pulmonary rehabilitation.
All Cause Mortality
	Pulmonary Rehabilitation Group		The Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Serious Adverse Events
	Pulmonary Rehabilitation Group		The Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/18 (0%)		0/18 (0%)
Other (Not Including Serious) Adverse Events
	Pulmonary Rehabilitation Group		The Control Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	6/18 (33.3%)		6/18 (33.3%)
Surgical and medical procedures
Prolonged air leak (PAL)	6/18 (33.3%)	18	6/18 (33.3%)	18

Limitations/Caveats

First,sample size is low,this may affect the result of the study;secondly, pulmonary function should collect DLCO and MVV;third,although the patients were checked via telephone every week,there is no surefire way to enforce intervention.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.