Use of the ADL-Glittre Test in the Pre and Postoperative Period of Patients With Lung Cancer

Sponsor

Centro Universitário Augusto Motta (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT05863013

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

11.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Lung cancer is the most common type of cancer and the leading cause of cancer death worldwide, in both men and women. Improvements in earlier preoperative staging and more effective adjuvant treatment have improved survival in non-small cell lung cancer, although surgical resection remains the mainstay of care for all patients in stages I to IV.

This study proposes to evaluate the functional capacity through TGlittre in patients with non-small cell lung cancer, before and after thoracic surgery, taking into account the predictive role of this test in the risk of complications and in the evaluation of the impact of functional rehabilitation.

Condition or Disease	Intervention/Treatment	Phase
Lung Cancer, Nonsmall Cell Quality of Life Physical Disability Surgery	Other: ADL-Glittre Test	N/A

Detailed Description

In the population of patients with lung cancer, two critical points that constitute gaps in the literature are: 1) the definition of operability using only pulmonary function tests and the consequent preparation of the patient for the surgical act; and 2) the postoperative approach and the consequent screening aimed at improving quality of life and reducing morbidity. In addition to the sophistication of pulmonary rehabilitation that has occurred in recent decades, the ADL-Glittre test was also developed, which is a measure of submaximal effort that assesses functional capacity and encompasses several tasks that simulate activities of daily living involving both lower limbs the higher, being an easy to administer, valid and reliable test to measure the functional status. This study proposes to evaluate the functional capacity through TGlittre in patients with non-small cell lung cancer, before and after thoracic surgery, taking into account the predictive role of this test in the risk of complications and in the evaluation of the impact of functional rehabilitation. As specific objectives, this study seeks to: test the reliability and validity of TGlittre in patients with non-small cell lung cancer; compare the results of TGlittre with those of lung function and quality of life in the pre- and postoperative period; to determine the impact of the preoperative pulmonary rehabilitation program on performance on the TGlittre; to determine the impact of the postoperative PR program on TGlittre performance; and to evaluate the incidence of postoperative complications and length of stay, considering the performance in TGlittre and the performance in the PR program. Using block randomization, participants who meet the inclusion criteria will be randomly assigned to one of 2 groups: 1) Intervention Group: Pulmonary Rehabilitation; and 2) Control Group: Standard Care. PR will be performed pre- and postoperatively, lasting 4 and 12 weeks, respectively. These participants will submit to the following tests: International Physical Activity Questionnaire; St. George's Respiratory Questionnaire; lung function (spirometry, measurement of lung diffusion capacity to carbon monoxide and measurement of respiratory muscle strength); handgrip strength; quadriceps strength; and TGlittre. The aim of this study is to support the applicability of TGlittre as an evaluative strategy for pulmonary rehabilitation in the pre- and postoperative periods of patients with non-small cell lung cancer, and also to verify the impact of pre- and postoperative rehabilitation strategies on quality of life, morbidity and mortality.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Patients included in the study will be evaluated: T0 (baseline): Baseline assessments will be performed immediately prior to randomization and will include lung function [spirometry, measurement of pulmonary CO2 diffusing capacity (DLCO) and measurement of respiratory muscle strength], handgrip measurement , measurement of quadriceps strength (HR ), exercise capacity (TGlittre1), level of physical activity in daily life (International Physical Activity Questionnaire - IPAQ) and assessment of QoL (St. George's Respiratory Questionnaire - SGRQ). T1 (day before surgery): Patients will repeat lung function, HGS measurement, HR measurement, TGlittre2, IPAQ, and SGRQ. T2 (1 month after surgery): Patients will repeat the tests from the previous phase. Data on postoperative complications and 30-day complications and mortality will also be recorded. T3 (4 months after surgery): Patients will have repeat lung function, HGS measurement, HR measurement, TGlittre4, IPAQ, and SGRQ.Patients included in the study will be evaluated:T0 (baseline): Baseline assessments will be performed immediately prior to randomization and will include lung function [spirometry, measurement of pulmonary CO2 diffusing capacity (DLCO) and measurement of respiratory muscle strength], handgrip measurement , measurement of quadriceps strength (HR ), exercise capacity (TGlittre1), level of physical activity in daily life (International Physical Activity Questionnaire - IPAQ) and assessment of QoL (St. George's Respiratory Questionnaire - SGRQ). T1 (day before surgery): Patients will repeat lung function, HGS measurement, HR measurement, TGlittre2, IPAQ, and SGRQ. T2 (1 month after surgery): Patients will repeat the tests from the previous phase. Data on postoperative complications and 30-day complications and mortality will also be recorded. T3 (4 months after surgery): Patients will have repeat lung function, HGS measurement, HR measurement, TGlittre4, IPAQ, and SGRQ.

Masking:

Single (Outcomes Assessor)

Masking Description:

The sample will be divided into two groups: Intervention Group and Control Group. Patients meeting the inclusion criteria will be randomly assigned to one of 2 groups (GI and CG) in a 1:1 ratio using a computer-generated random allocation sequence using the stratified block randomization method of SAS version 9.1. 3 (SAS Institute, Cary, NC, USA). Randomization will be performed by an independent research assistant who will not participate in any other phase of this study. The health professionals who will work in the study (physicians and physiotherapists) will be informed of the assignment of the treatment by telephone confirmation. The evaluators of clinical and statistical results will be "blinded" to the randomization, since it was not feasible to "blind" the other professionals involved in the research.

Primary Purpose:

Treatment

Official Title:

Longitudinal Changes in the ADL-Glittre Test in Patients With Lung Cancer: Pre- and Postoperative Analysis Using Rehabilitation in a Randomized Controlled Trial

Anticipated Study Start Date :

May 1, 2023

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Health education and home care They will receive standard care: a therapeutic education session on admission, plus daily in-house early postoperative rehabilitation, delivered by a physiotherapist. The therapeutic educational session will involve counseling and self-care management, aiming to prepare patients for the postoperative period, emphasizing breathing exercises and sputum clearance techniques, pain control strategies and self-care. It will consist of smoking cessation education, respiratory retraining (pursed-lip breathing, diaphragmatic breathing, and segmental breathing), and secretion clearance training (coughing exercise, huffing, assisted coughing, and postural drainage).
Experimental: Pulmonary rehabilitation They will receive standard care described (AP) plus perioperative PR, with 20 preoperative and 60 postoperative sessions. The preoperative sessions will be held 2X/week, in addition to the home sessions 3X/week. Each outpatient session will last 2 hours and will consist of therapeutic education, aerobic exercises, resistance training of lower limbs, upper limbs and abdominal wall, and respiratory muscle training (RMT), which will include breathing pattern, positive expiratory pressure and inspiratory muscles training and home will last for 1h, unsupervised and personalized MRT plus 30 min of aerobic walking at an intensity of 60-80% of maximum HR. Participants will receive a portable pedometer and HR monitor. Postoperative rehabilitation will be offered only to the IG, from 1 month after surgery, with 60 sessions divided into 24 outpatient sessions performed 2X/week and 36 home sessions 3X/week. The postoperative program will last 12 weeks.	Other: ADL-Glittre Test They will receive standard care described plus perioperative pulmonary rehabilitation, with 20 preoperative sessions and 60 postoperative sessions. Preoperative sessions will be held 2X/week, in addition to home sessions 3X/week. Each outpatient session will last 2 hours and will consist of therapeutic education, aerobic exercises, resistance training of lower limbs, upper limbs and abdominal wall and respiratory muscle training (RMT), which will include breathing pattern, positive expiratory pressure and training of inspiratory and respiratory muscles. home will last 1h, unsupervised and personalized MRT plus 30 min of aerobic walking at 60-80% of maximum HR intensity. Participants will receive a portable pedometer and HR monitor. Postoperative rehabilitation will be offered only to the IG, from 1 month after surgery, with 60 sessions divided into 24 outpatient sessions performed 2X/week and 36 home sessions 3X/week. The postoperative program will last 12 weeks.

Arm

Intervention/Treatment

No Intervention: Health education and home care

They will receive standard care: a therapeutic education session on admission, plus daily in-house early postoperative rehabilitation, delivered by a physiotherapist. The therapeutic educational session will involve counseling and self-care management, aiming to prepare patients for the postoperative period, emphasizing breathing exercises and sputum clearance techniques, pain control strategies and self-care. It will consist of smoking cessation education, respiratory retraining (pursed-lip breathing, diaphragmatic breathing, and segmental breathing), and secretion clearance training (coughing exercise, huffing, assisted coughing, and postural drainage).

Experimental: Pulmonary rehabilitation

They will receive standard care described (AP) plus perioperative PR, with 20 preoperative and 60 postoperative sessions. The preoperative sessions will be held 2X/week, in addition to the home sessions 3X/week. Each outpatient session will last 2 hours and will consist of therapeutic education, aerobic exercises, resistance training of lower limbs, upper limbs and abdominal wall, and respiratory muscle training (RMT), which will include breathing pattern, positive expiratory pressure and inspiratory muscles training and home will last for 1h, unsupervised and personalized MRT plus 30 min of aerobic walking at an intensity of 60-80% of maximum HR. Participants will receive a portable pedometer and HR monitor. Postoperative rehabilitation will be offered only to the IG, from 1 month after surgery, with 60 sessions divided into 24 outpatient sessions performed 2X/week and 36 home sessions 3X/week. The postoperative program will last 12 weeks.

Other: ADL-Glittre Test

They will receive standard care described plus perioperative pulmonary rehabilitation, with 20 preoperative sessions and 60 postoperative sessions. Preoperative sessions will be held 2X/week, in addition to home sessions 3X/week. Each outpatient session will last 2 hours and will consist of therapeutic education, aerobic exercises, resistance training of lower limbs, upper limbs and abdominal wall and respiratory muscle training (RMT), which will include breathing pattern, positive expiratory pressure and training of inspiratory and respiratory muscles. home will last 1h, unsupervised and personalized MRT plus 30 min of aerobic walking at 60-80% of maximum HR intensity. Participants will receive a portable pedometer and HR monitor. Postoperative rehabilitation will be offered only to the IG, from 1 month after surgery, with 60 sessions divided into 24 outpatient sessions performed 2X/week and 36 home sessions 3X/week. The postoperative program will last 12 weeks.

Outcome Measures

Primary Outcome Measures

Functional capacity through the Glittre Activities of Daily Living test (ADL-Glittre test). [six months]
The participant must complete 5 laps in the shortest possible time. The test consists of carrying a backpack containing a 2.5kg weight completing a circuit with the following activities. The participant rises from a seated position and walks on a 10-m flat course, interposed halfway by a stairway with 2 steps to ascend and 2 to descend. After completing the course, the individual approaches a 2-teir shelf containing 3 objects weighing 1kg each, placed on the highest shelf (shoulder height), that must be moved 1 by 1 to the bottom shelf (waist height) and then down to the floor. Then, the objects are placed on the bottom shelf again and finally on the top shelf. Then, the individual turns and walks back over the course; immediately after completion of 1 lap, another lap is started, completing the same circuit. The instructions are standardized, and there is no incentive during the test. Two tests are performed with a minim.

Secondary Outcome Measures

International Physical Activity Questionnaire (IPAQ) [six months]
The International Physical Activity Questionnaire (IPAQ) contains seven open questions and aims to quantify the weekly time spent in physical activities of moderate and vigorous intensity, in different everyday contexts, such as work, transportation, household chores and leisure, and also the time spent in passive activities performed in a sitting position. To answer the questions, participants will be instructed to consider the week before the IPAQ application date and will subsequently be classified according to the level of activity as sedentary, irregularly active, active or very active, according to the weekly frequency and duration of activities performed.
St. George's Respiratory Questionnaire (SGRQ) [six months]
To measure quality of life, the Saint George Hospital questionnaire on respiratory disease was applied, which was validated and adapted for the Brazilian population. This instrument covers aspects in three domains, which are: symptoms, activity and psychosocial impacts that the disease can influence in their daily routine. The answers translate into points that, once added together, can infer about an altered Quality of life in a given domain. A score is calculated for each domain (0-100 points) and a total score is also calculated, the higher the score, the worse the measured quality of life.
Handgrip strength (HGS) [six months]
HGS will be measured in kilograms using a handheld digital dynamometer (SH5001, Saehan Corporation, Korea). The HGS will be evaluated with the participants sitting in a chair without arms, with elbow flexion at 90°, forearms in a neutral position and extension wrist angle between 0 and 30°. The maximum force will be evaluated after sustained contraction of 3s in the dominant hand; the highest value of 3 attempts with 1 min intervals will be considered for analysis.
Quadriceps strength [six months]
Quadriceps strength will be assessed using a traction dynamometer with a sensor capacity of 200 kg (E-lastic 5.0, E-sport SE, Brazil). The amplitude of movement in the execution of the test will be determined in 90°, starting from 90° with the knee in flexion. Maximum strength will be evaluated after a sustained contraction of 5 s on the dominant leg, and the highest value from 3 attempts with 1-min intervals will be considered for analysis.
Spirometry- forced expiratory volume in one second (FEV1) [six months]
During the spirometry test, the individual must remain seated, with the head in a neutral position to avoid changes in expiratory flows. The evaluator must advise that the maneuvers are performed through encouragement and verbal stimulation. The procedure must be guided and demonstrated by the technician, through a tube. It is necessary for the patient to perform a maximum inspiration, followed by a rapid and sustained expiration. The measure of forced expiratory volume in one second (FEV1) will be evaluated, which is the amount of air eliminated in the first second of the forced expiratory maneuver.
Spirometry- Forced Vital Capacity (FVC) [six months]
During the spirometry test, the measurement of forced vital capacity (FVC) will also be evaluated, which can be identified through the volume eliminated in the forced expiratory maneuver from total lung capacity to residual volume.
Spirometry- Peak Expiratory Flow (PEF) [six months]
During the spirometry test, the peak expiratory flow (PEF) will also be evaluated, which represents the maximum air flow during the FVC maneuver. PEF is an effort-dependent expiratory parameter that reflects the caliber of the proximal airways and is often used as an effective cough marker.
Carbon monoxide diffusion capacity (DLCO) [Six months]
For the DLCO analysis, the use of a nose clip will be requested (in order to avoid nasal breathing), remaining in a sitting position and coupling to the pulmonary function device through an appropriate mouthpiece. After slow expiration to residual volume, rapid but not forced inspiration will be performed. Upon reaching full lung capacity, an inspiratory pause of approximately 10s will occur and then the inhaled gas will be exhaled smoothly and without interruptions. The expired air volume will be collected for analysis that will determine the difference between inspired CO and expired CO (diffused CO).
Respiratory muscle strength [Six months]
For analysis of respiratory muscle strength, measurements of inspiratory pressure and maximum expiratory pressure will be recorded. The individual must remain in a sitting position, with the head in a neutral position and is asked to perform a maximum expiration, that is, up to the residual volume, to measure the inspiratory pressure. Next, the patient makes a maximal inspiratory effort against the occluded airway. To verify the expiratory pressure, the patient is instructed to perform a maximum inspiration up to the level of total lung capacity, then, they must perform a maximum expiratory effort against the occluded airway. The maximum value of three maneuvers that varied less than 20%, the variability within the measurements, the predicted value, and the lower limit of normality range will be recorded. National equations will be adopted to calculate the predicted values of each participant.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosis of NSCLC stages I to IV, that is, those patients without evidence of mediastinal disease or local organ invasion.
Age equal to or greater than 18 years.
The following types of lung surgery: pneumonectomy, bilobectomy, lobectomy, segmentectomy and wedge resection.
Resection by thoracotomy or video-assisted thoracoscopic surgery.

Exclusion Criteria:

Patients known to need adjuvant treatments.
Show inability to walk.
Not being able to perform pulmonary function tests and/or functional tests.
Presence of cardiovascular, neurological or orthopedic diseases.
Bronchopleural fistula, sudden increase in chest drainage or active intrathoracic hemorrhage, chylothorax or other serious adverse events.