COPDMUST: COPD: A Multi-center Supervised Tele-rehabilitation Study

Sponsor

China-Japan Friendship Hospital (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT06085261

Collaborator

(none)

360

Enrollment

Location

Arms

Anticipated Duration (Months)

27.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Behavioral: home-based telerehabilitation group Behavioral: center-based traditional rehabilitation group	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

360 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Anticipated Study Start Date :

Nov 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2024

Anticipated Study Completion Date :

Dec 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: home-based telerehabilitation 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 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.
Active Comparator: center-based traditional rehabilitation 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 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.

Arm

Intervention/Treatment

Experimental: home-based telerehabilitation

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

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.

Active Comparator: center-based traditional rehabilitation

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

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.

Outcome Measures

Primary Outcome Measures

6-minute walk distance (6MWD) [8 weeks; 20 weeks]
6-minute walk distance

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.