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

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
home-based telerehabilitation group
center-based traditional rehabilitation group
Sponsored by
China-Japan Friendship Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring COPD, pulmonary rehabilitation, tele-rehabilitation

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • China-Japan Friendship hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

home-based telerehabilitation

center-based traditional rehabilitation

Arm Description

Remotely supervised telerehabilitation at home will be conducted for 8 weeks, comprising lower limb aerobic training, individualized strength training and respiratory training exercises.

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.

Outcomes

Primary Outcome Measures

6-minute walk distance (6MWD)
6-minute walk distance

Secondary Outcome Measures

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

Full Information

First Posted
August 6, 2023
Last Updated
October 13, 2023
Sponsor
China-Japan Friendship Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT06085261
Brief Title
COPD: A Multi-center Supervised Tele-rehabilitation Study
Acronym
COPDMUST
Official Title
Chronic Obstructive Pulmonary Disease: A Multi-center Supervised Tele-rehabilitation Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
August 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
China-Japan Friendship Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
COPD, pulmonary rehabilitation, tele-rehabilitation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
360 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
home-based telerehabilitation
Arm Type
Experimental
Arm Description
Remotely supervised telerehabilitation at home will be conducted for 8 weeks, comprising lower limb aerobic training, individualized strength training and respiratory training exercises.
Arm Title
center-based traditional rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
home-based telerehabilitation group
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
center-based traditional rehabilitation group
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-minute walk distance (6MWD)
Description
6-minute walk distance
Time Frame
8 weeks; 20 weeks
Secondary Outcome Measure Information:
Title
pulmonary function
Description
forced expiratory volume in 1 second (FEV1) [velocity]
Time Frame
8 weeks; 20 weeks
Title
pulmonary function
Description
ratio between FEV1 and forced vital capacity (FEV1/FVC) [velocity]
Time Frame
8 weeks; 20 weeks
Title
pulmonary function
Description
forced expiratory flow between 25 and 75% of forced vital capacity (FEF25-75%) [velocity]
Time Frame
8 weeks; 20 weeks
Title
pulmonary function
Description
inspiratory capacity (IC) [velocity]
Time Frame
8 weeks; 20 weeks
Title
pulmonary function
Description
residual volume (RV) [velocity]
Time Frame
8 weeks; 20 weeks
Title
pulmonary function
Description
total lung capacity (TLC) [velocity]
Time Frame
8 weeks; 20 weeks
Title
pulmonary function
Description
diffusing capacity of the lung for carbon monoxide (DLCO) [velocity]
Time Frame
8 weeks; 20 weeks
Title
Respiratory muscle strength
Description
maximum inspiratory pressure(MIP), maximum expiratory pressure(MEP)
Time Frame
8 weeks; 20 weeks
Title
Short Physical Performance Battery(SPPB)
Description
Test for health-related physical performance
Time Frame
8 weeks; 20 weeks
Title
modified British medical research council(mMRC)
Description
It is a self-reported symptom questionnaire ranging from 0-4 score, higher scores mean a worse outcome.
Time Frame
8 weeks; 20 weeks
Title
COPD assessment test(CAT)
Description
It is a self-reported quality of life questionnaire ranging from 0-10 score, higher scores mean a worse outcome.
Time Frame
8 weeks; 20 weeks
Title
St. George's Respiratory Questionnaire (SGRQ)
Description
It is a self-reported symptom questionnaire ranging from 0-100 score, higher scores mean a worse outcome.
Time Frame
8 weeks; 20 weeks
Title
Hospital Anxiety and Depression Scale(HADS)
Description
It is a self-reported psychological status questionnaire ranging from 0-42 score, higher scores mean a worse outcome.
Time Frame
8 weeks; 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ting Yang, MD
Phone
84206272
Email
zryyyangting@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shiwei Qumu, Dr
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Study Director
Facility Information:
Facility Name
China-Japan Friendship hospital
City
Beijing
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shiwei Qumu

12. IPD Sharing Statement

Learn more about this trial

COPD: A Multi-center Supervised Tele-rehabilitation Study

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