Telerehabilitation Improves QoL, Physical Functions and Compliance in Patients With COPD

Sponsor

National Cheng-Kung University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT04870632

Collaborator

(none)

Enrollment

Location

Arms

16.3

Actual Duration (Months)

1.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The video-delivered pulmonary rehabilitation(PR) program is more convenience for COPD patient to carry out home-based PR. Also, the intervention will improve cardiopulmonary functions, QoL, and physical activity.

Condition or Disease	Intervention/Treatment	Phase
COPD Pulmonary Rehabilitation Telerehabilitation Cardiopulmonary Exercise Test Compliance, Patient	Other: Education Other: Video-based pulmonary rehabilitation Other: Booklet-based pulmonary rehabilitation	N/A

Detailed Description

Background and Purpose: Chronic obstructive pulmonary disease (COPD) is the 3rd global cause of deaths. Pulmonary rehabilitation (PR) is the standard treatment for this disease. However, the dropout rate remains high (33-50%) because of traffic issues and patients' low mobility. Therefore, telerehabilitation seems to be a better way to deliver PR. Using videos to deliver PR is not only easy to manipulate on the cellphone or ipad, but also improve patients' attention and compliance. Thus, the aim of this study is to assess whether tailor-made PR video rehabilitation program improves patients' quality of life (QoL), muscle strengths, cardiopulmonary functions, and compliance.

Methods: This is a randomized controlled trial with 6-week follow-up. Participants were medically stable COPD patients and able to use LINE and YOUTUBE in cellphone. In the process of recruitment, they were all assessed by time-up-and-go test. The performance of time-up-and-go test should be lower than 12 seconds to rule out the participants with high risks of falling. They were randomly assigned to control group or intervention group to conduct 6-week home-based PR program. Patients in control group received the education booklet with words and pictures. Patients in intervention group watched YOUTUBE videos to rehab and recorded the intensity after the exercise by RPE scores. During the intervention, a physical therapist would have weekly telephone calls or LINE calls for 6 times to monitor and modify the intensity of exercise. The videos included 5-minute breathing reeducation, 20-minute interval strengthening exercise and 5-minute education animation. All patients were assessed the performance of spirometry, cardiopulmonary exercise test (CPET), questionnaires about symptoms, QoL, muscle strengths and distances of 6-minute walk test (6MWT) before intervention, after intervention and after 6-week follow-up.

Study Design

Study Type:

Interventional

Actual Enrollment :

25 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Personalized Video-delivered Telerehabilitation Improves QoL, Muscle Strengths, Cardiopulmonary Functions and Compliance in Patients With COPD

Actual Study Start Date :

Mar 2, 2020

Actual Primary Completion Date :

May 31, 2021

Actual Study Completion Date :

Jul 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Sham Comparator: Control group Patients in control group received the education booklet with words and pictures.	Other: Education COPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.
Experimental: Video group Patients in intervention group watched YOUTUBE videos to rehab and recorded the intensity after the exercise by RPE scores. During the intervention, a physical therapist would have weekly telephone calls or LINE calls for 6 times to monitor and modify the intensity of exercise.	Other: Video-based pulmonary rehabilitation COPD patients conduct pulmonary rehabilitation for 6 weeks by watching Youtube videos which were made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form.
Experimental: Booklet group Patients in intervention group read education booklet with words and pictures to rehab and recorded the intensity after the exercise by RPE scores. During the intervention, a physical therapist would have weekly telephone calls or LINE calls for 6 times to monitor and modify the intensity of exercise.	Other: Booklet-based pulmonary rehabilitation COPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form.

Arm

Intervention/Treatment

Sham Comparator: Control group

Patients in control group received the education booklet with words and pictures.

Other: Education

COPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.

Experimental: Video group

Patients in intervention group watched YOUTUBE videos to rehab and recorded the intensity after the exercise by RPE scores. During the intervention, a physical therapist would have weekly telephone calls or LINE calls for 6 times to monitor and modify the intensity of exercise.

Other: Video-based pulmonary rehabilitation

COPD patients conduct pulmonary rehabilitation for 6 weeks by watching Youtube videos which were made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form.

Experimental: Booklet group

Patients in intervention group read education booklet with words and pictures to rehab and recorded the intensity after the exercise by RPE scores. During the intervention, a physical therapist would have weekly telephone calls or LINE calls for 6 times to monitor and modify the intensity of exercise.

Other: Booklet-based pulmonary rehabilitation

COPD patients conduct pulmonary rehabilitation for 6 weeks by read an education booklet with words and pictures which is made by the physiotherapist.The patients are monitored by the physiotherapist by weekly phone call and asked to record RPE scores at the RPE form.

Outcome Measures

Primary Outcome Measures

Time point difference of AT from 1st week to 6th week [From 1st week to 6th week]
Use cardiopulmonary exercise test (CPET) to get the change of time point difference of AT from 1st week(intervention starts) to 6th week(intervention ends)
Time point difference of AT from 1st week to 12th week [From 1st week to 12th week]
Use cardiopulmonary exercise test (CPET) to get the change of time point difference of AT from 1st week(intervention starts) to 12th week(follow up ends)
Time point difference of AT from 6th week to 12th week [From 6th week to 12th week]
Use cardiopulmonary exercise test (CPET) to get the change of time point of AT from 6th week(intervention ends) to 12th week(follow up ends)
Change of maximal exercise work from 1st week to 6th week [From 1st week to 6th week]
Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 1st week(intervention starts) to 6th week(intervention ends)
Change of maximal exercise work from 1st week to 12th week [From 1st week to 12th week]
Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 1st week(intervention starts) to to 12th week(follow up ends)
Change of maximal exercise work from 6th week to 12th week [From 6th week to 12th week]
Use cardiopulmonary exercise test (CPET) to get the change of values of the pateint's total work (watt) from 6th week(intervention ends) to 12th week(follow up ends)
Change of VO2max from 1st week to 6th week [From 1st week to 6th week]
Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 1st week(intervention starts) to 6th week(intervention ends)
Change of VO2max from 1st week to 12th week [From 1st week to 12th week]
Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 1st week(intervention starts) to 12th week(follow up ends)
Change of VO2max from 6th week to 12th week [From 6th week to 12th week]
Use cardiopulmonary exercise test (CPET) to get the change of values of VO2max (mL/min/kg) from 6th week(intervention ends) to 12th week(follow up ends)
Change of VE/VCO2 from 1st week to 6th week [From 1st week to 6th week]
Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 1st week(intervention starts) to 6th week(intervention ends)
Change of VE/VCO2 from 1st week to 12th week [From 1st week to 12th week]
Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 1st week(intervention starts) to 12th week(follow up ends)
Change of VE/VCO2 from 6th week to 12th week [From 6th week to 12th week]
Use cardiopulmonary exercise test (CPET) to get the change of values of VE/VCO2 from 6th week(intervention ends) to 12th week(follow up ends)
Change of muscle strength from 1st week to 6th week [From 1st week to 6th week]
Use dynamometer to measure the changes of muscle strength(kg) from 1st week(intervention starts) to 6th week(intervention ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)
Change of muscle strength from 1st week to 12th week [From 1st week to 12th week]
Use dynamometer to measure the changes of muscle strength(kg) from 1st week(intervention starts) to 12th week(follow up ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)
Change of muscle strength from 6th week to 12th week [From 6th week to 12th week]
Use dynamometer to measure the changes of muscle strength(kg) from 6th week(intervention ends) to 12th week(follow up ends), including bilateral handgrip, elbow flexors (biceps) and knee extensors (quadriceps) for 3 times separately.The patient need to increase the strength to the highest level in 6 seconds and rest for 30 seconds.The highest value will be divided by the patient's body weight (kg/kg)
Change of 6-minute walk test from 1st week to 6th week [From 1st week to 6th week]
Measure the change of 6-minute walk test from 1st(intervention starts) week to 6th week(intervention ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.
Change of 6-minute walk test from 1st week to 12th week [From 1st week to 12th week]
Measure the change of 6-minute walk test from 1st(intervention starts) week to 12th week(follow up ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.
Change of 6-minute walk test from 6th week to 12th week [From 6th week to 12th week]
Measure the change of 6-minute walk test from 6th(intervention ends) week to 12th week(follow up ends).The patient walks in his/her own pace, as far as he/she can in 6 minutes at the 20-meter long straight path and the we will record the distance in meter.Stop when time's up or patient develops clinical symptoms.
Attendance rate in video group or booklet group [From 1st week to 6th week]
If the patient completes 70% or more of the intervention program by being analyzed from the record of RPE form, he/she will be recognize as being completed the intervention.Finally, we will count the number of the patients who completed the intervention to be divided by the number of totally patients in video/booklet group at 6th week.

Secondary Outcome Measures

FEV1 [Baseline, 6 weeks later, and 12 weeks later]
Use spirometry to measure the values of FEV1 (%) for 3 times.The highest result will be recored.
FEV1/FVC [Baseline, 6 weeks later, and 12 weeks later]
Use spirometry to measure the values of FEV1/FVC for 3 times.The highest result will be recored.
Modified Medical Research Council (mMRC) [Baseline, 6 weeks later, and 12 weeks later]
Level of Modified Medical Research Council (mMRC)
COPD Assessment Test (CAT) [Baseline, 6 weeks later, and 12 weeks later]
Total score of COPD Assessment Test (CAT)
EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) [Baseline, 6 weeks later, and 12 weeks later]
Score of EuroQol-5 Dimensions-5 Levels (EQ-5D-5L)
Clinical COPD Questionnaires (CCQ) [Baseline, 6 weeks later, and 12 weeks later]
Score of Clinical COPD Questionnaires (CCQ)

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

COPD
Be medically stable
Ability to use a smartphone and applications (LINE and Youtube)
Access to the internet
Have visual and auditory impairments corrected with assistive devices

Exclusion Criteria:

Other respiratory disease as main complaint other than COPD
Exacerbations within 4 weeks
Had enrolled PR programs within the last 6 months
Unable to follow verbal instructions, suffer from cognitive impairment, or have language difficulties
Unstable medical conditions
Any comorbidities which precluded exercise training