Skip to content

COPD: A Multi-center Supervised Tele-rehabilitation Study

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06085261
Acronym
COPDMUST
Enrollment
360
Registered
2023-10-16
Start date
2023-11-30
Completion date
2024-12-31
Last updated
2023-10-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD, pulmonary rehabilitation, tele-rehabilitation

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.

Interventions

BEHAVIORALhome-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.

BEHAVIORALcenter-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.

Sponsors

China-Japan Friendship Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

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.

Design outcomes

Primary

MeasureTime frameDescription
6-minute walk distance (6MWD)8 weeks; 20 weeks6-minute walk distance

Secondary

MeasureTime frameDescription
Respiratory muscle strength8 weeks; 20 weeksmaximum inspiratory pressure(MIP), maximum expiratory pressure(MEP)
Short Physical Performance Battery(SPPB)8 weeks; 20 weeksTest for health-related physical performance
modified British medical research council(mMRC)8 weeks; 20 weeksIt is a self-reported symptom questionnaire ranging from 0-4 score, higher scores mean a worse outcome.
pulmonary function8 weeks; 20 weeksforced expiratory volume in 1 second (FEV1) \[velocity\]
St. George's Respiratory Questionnaire (SGRQ)8 weeks; 20 weeksIt 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 weeksIt is a self-reported psychological status questionnaire ranging from 0-42 score, higher scores mean a worse outcome.
COPD assessment test(CAT)8 weeks; 20 weeksIt is a self-reported quality of life questionnaire ranging from 0-10 score, higher scores mean a worse outcome.

Countries

China

Contacts

Primary ContactTing Yang, MD
zryyyangting@163.com84206272

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026