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

October 13, 2023 updated by: Ting YANG, China-Japan Friendship Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

360

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
      • Beijing, China
        • China-Japan Friendship Hospital
        • Contact:
          • Shiwei Qumu

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Participants with a clinical diagnosis of and meeting the following criteria are eligible:

  1. Diagnosis of COPD of Global Initiative for Chronic Obstructive Lung Disease (GOLD) II-IV and without acute exacerbation within the last 2 weeks.
  2. Motivated for participating in the project (and acceptance of randomization)
  3. Sufficient mobility to attend PR

Exclusion Criteria:

  1. Certain comorbidities (e.g. unstable coronary complications)
  2. Severe cognitive disabilities (e.g. dementia)
  3. Inability to cope with the program because of severe hearing or visual disorder.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant 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.

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China-Japan Friendship Hospital

Investigators

  • Study Director: Shiwei Qumu, Dr, China-Japan Friendship Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 1, 2023

Primary Completion (Estimated)

August 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

August 6, 2023

First Submitted That Met QC Criteria

October 13, 2023

First Posted (Actual)

October 16, 2023

Study Record Updates

Last Update Posted (Actual)

October 16, 2023

Last Update Submitted That Met QC Criteria

October 13, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-I2M-1-409

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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