COPD: A Multi-center Supervised Tele-rehabilitation Study

Study Overview
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Brief Summary
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Chronic obstructive pulmonary disease(COPD) patients could benefit from pulmonary rehabilitation(PR) in better managing of the disease and its symptoms and in avoiding future relapses and hospitalizations. However, due to a large number of drop outs from PR, lack of professionals, and the (Corona Virus Disease 2019) COVID-19 epidemic, the PR has been underutilized, leading to a need for investigation of updated forms. The study aims to investigate the effects of a home-based PR program using minimal accessories, facilitated with wearable activity trackers and smartphones.

Official Title
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Chronic Obstructive Pulmonary Disease: A Multi-center Supervised Tele-rehabilitation Study

Conditions
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Chronic Obstructive Pulmonary Disease

Intervention / Treatment
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* Behavioral: home-based telerehabilitation group
* Behavioral: center-based traditional rehabilitation group


Participation Criteria
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Eligibility Criteria
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Participants with a clinical diagnosis of and meeting the following criteria are eligible: Diagnosis of COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV and without acute exacerbation within the last 2 weeks. Motivated for participating in the project (and acceptance of randomization) Sufficient mobility to attend PR Exclusion Criteria: Certain comorbidities (e.g. unstable coronary complications) Severe cognitive disabilities (e.g. dementia) Inability to cope with the program because of severe hearing or visual disorder.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: home-based telerehabilitation<br>Remotely supervised telerehabilitation at home will be conducted for 8 weeks, comprising lower limb aerobic training, individualized strength training and respiratory training exercises. | Behavioral: home-based telerehabilitation group<br>* Participants will download the web application in their smartphones in the hospital's outpatient clinic and learn to use the sports wristwatch. Remotely supervised telerehabilitation at home will be conducted for 8 weeks, comprising lower limb aerobic training, individualized strength training and respiratory training exercises. The initial aerobic exercise prescription for walking will be set at 80% of the speed walked during a 6-minute walk test (6MWT) and progressed each 4-week according to patient assessments. Resistance training for the arms and legs will utilize elastic bands, while respiratory training will utilize portable breathing trainer. During each training session, participants will be asked to follow the videos in the web application, wearing the sports wristwatch recording their exercise intensity. At the end of every training session, training data could be uploaded to the web platform automatically, which will be checked by staff in hospital.<br>|
| Active Comparator: center-based traditional rehabilitation<br>Participants will undertake an aerobic, strength and respiratory training program of similar intensity and duration to the home-based program, at their site of recruitment. | Behavioral: center-based traditional rehabilitation group<br>* Participants will undertake an aerobic, strength and respiratory training program of similar intensity and duration to the home-based program, at their site of recruitment. The initial aerobic exercise prescription for cycling will be set at 60% of the peak oxygen uptake (VO2) on a cardiopulmonary exercise test (CPET). Resistance training and respiratory training are similar to the telerehabilitation group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk distance (6MWD) | 6-minute walk distance | 8 weeks; 20 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pulmonary function | forced expiratory volume in 1 second (FEV1) [velocity] | 8 weeks; 20 weeks | 
| pulmonary function | ratio between FEV1 and forced vital capacity (FEV1/FVC) [velocity] | 8 weeks; 20 weeks | 
| pulmonary function | forced expiratory flow between 25 and 75% of forced vital capacity (FEF25-75%) [velocity] | 8 weeks; 20 weeks | 
| pulmonary function | inspiratory capacity (IC) [velocity] | 8 weeks; 20 weeks | 
| pulmonary function | residual volume (RV) [velocity] | 8 weeks; 20 weeks | 
| pulmonary function | total lung capacity (TLC) [velocity] | 8 weeks; 20 weeks | 
| pulmonary function | diffusing capacity of the lung for carbon monoxide (DLCO) [velocity] | 8 weeks; 20 weeks | 
| Respiratory muscle strength | maximum inspiratory pressure(MIP), maximum expiratory pressure(MEP) | 8 weeks; 20 weeks | 
| Short Physical Performance Battery(SPPB) | Test for health-related physical performance | 8 weeks; 20 weeks | 
| modified British medical research council(mMRC) | It is a self-reported symptom questionnaire ranging from 0-4 score, higher scores mean a worse outcome. | 8 weeks; 20 weeks | 
| COPD assessment test(CAT) | It is a self-reported quality of life questionnaire ranging from 0-10 score, higher scores mean a worse outcome. | 8 weeks; 20 weeks | 
| St. George's Respiratory Questionnaire (SGRQ) | It is a self-reported symptom questionnaire ranging from 0-100 score, higher scores mean a worse outcome. | 8 weeks; 20 weeks | 
| Hospital Anxiety and Depression Scale(HADS) | It is a self-reported psychological status questionnaire ranging from 0-42 score, higher scores mean a worse outcome. | 8 weeks; 20 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COPD, pulmonary rehabilitation, tele-rehabilitation