Chronic Obstructive Pulmonary DiseaseCOPDMUSTNCT06085261
COPD: A Multi-center Supervised Tele-rehabilitation Study
A study testing home-based telerehabilitation group and center-based traditional rehabilitation group in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 75 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- home-based telerehabilitation group and center-based traditional rehabilitation group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Nov 2023to Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- home-based telerehabilitation group, center-based traditional rehabilitation group
- Keywords
- COPD, pulmonary rehabilitation, tele-rehabilitation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home-based telerehabilitation groupBehavioural
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.
center-based traditional rehabilitation groupBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| home-based telerehabilitation | Experimental | Remotely supervised telerehabilitation at home will be conducted for 8 weeks, comprising lower limb aerobic training, individualized strength training and respiratory training exercises. Receives: Behavioral: home-based telerehabilitation group |
| center-based traditional rehabilitation | Active comparator | 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. Receives: Behavioral: center-based traditional rehabilitation group |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk distance (6MWD)
6-minute walk distance
Measured: 8 weeks; 20 weeks
Secondary outcomes (13)
pulmonary function
forced expiratory volume in 1 second (FEV1) [velocity]
Measured: 8 weeks; 20 weeks
pulmonary function
ratio between FEV1 and forced vital capacity (FEV1/FVC) [velocity]
Measured: 8 weeks; 20 weeks
pulmonary function
forced expiratory flow between 25 and 75% of forced vital capacity (FEF25-75%) [velocity]
Measured: 8 weeks; 20 weeks
pulmonary function
inspiratory capacity (IC) [velocity]
Measured: 8 weeks; 20 weeks
pulmonary function
residual volume (RV) [velocity]
Measured: 8 weeks; 20 weeks
pulmonary function
total lung capacity (TLC) [velocity]
Measured: 8 weeks; 20 weeks
pulmonary function
diffusing capacity of the lung for carbon monoxide (DLCO) [velocity]
Measured: 8 weeks; 20 weeks
Respiratory muscle strength
maximum inspiratory pressure(MIP), maximum expiratory pressure(MEP)
Measured: 8 weeks; 20 weeks
Short Physical Performance Battery(SPPB)
Test for health-related physical performance
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 8 weeks; 20 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2023
- Study startNov 2023 (estimated)
- Primary completionAug 2024 (estimated)
- Study completionDec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by China-Japan Friendship HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China-Japan Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ting YANG, China-Japan Friendship Hospital
- Investigators
- Shiwei Qumu, Dr, Study director, China-Japan Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06085261
- Sponsor's protocol ID
- 2021-I2M-1-409
- Acronym
- COPDMUST
- Status last verified
- Oct 2023
- First submitted
- 6 Aug 2023
- Last updated
- 16 Oct 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chronic Obstructive Pulmonary Disease: A Multi-center Supervised Tele-rehabilitation Study
- ClinicalTrials.gov ID
- NCT06085261
- Acronym / sponsor ID
- COPDMUST / 2021-I2M-1-409
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- COPD, pulmonary rehabilitation, tele-rehabilitation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- China-Japan Friendship HospitalUniversity, hospital or other
- Study start
- Nov 2023 (estimated)
- Primary completion
- Aug 2024 (estimated)
- Study completion
- Dec 2024 (estimated)
- First posted
- 16 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| home-based telerehabilitation | Experimental | Behavioral: home-based telerehabilitation groupRemotely supervised telerehabilitation at home will be conducted for 8 weeks, comprising lower limb aerobic training, individualized strength training and respiratory training exercises. |
| center-based traditional rehabilitation | Active comparator | Behavioral: center-based traditional rehabilitation groupParticipants will undertake an aerobic, strength and respiratory training program of similar intensity and duration to the home-based program, at their site of recruitment. |
Who may qualify
- Ages
- 40 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home-based telerehabilitation groupParticipants 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. | Behavioural | home-based telerehabilitation |
| center-based traditional rehabilitation groupParticipants 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. | Behavioural | center-based traditional rehabilitation |
Primary outcome
6-minute walk distance (6MWD)
Time frame: 8 weeks; 20 weeks
6-minute walk distance
13 secondary outcomes
pulmonary function
Time frame: 8 weeks; 20 weeks
pulmonary function
Time frame: 8 weeks; 20 weeks
pulmonary function
Time frame: 8 weeks; 20 weeks
pulmonary function
Time frame: 8 weeks; 20 weeks
pulmonary function
Time frame: 8 weeks; 20 weeks
pulmonary function
Time frame: 8 weeks; 20 weeks
pulmonary function
Time frame: 8 weeks; 20 weeks
Respiratory muscle strength
Time frame: 8 weeks; 20 weeks
Short Physical Performance Battery(SPPB)
Time frame: 8 weeks; 20 weeks
modified British medical research council(mMRC)
Time frame: 8 weeks; 20 weeks
COPD assessment test(CAT)
Time frame: 8 weeks; 20 weeks
St. George's Respiratory Questionnaire (SGRQ)
Time frame: 8 weeks; 20 weeks
Hospital Anxiety and Depression Scale(HADS)
Time frame: 8 weeks; 20 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shiwei Qumu, Dr study director
China-Japan Friendship Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing home-based telerehabilitation group and center-based traditional rehabilitation group in people with Chronic Obstructive Pulmonary Disease, run by China-Japan Friendship Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ting Yang, MD (84206272, zryyyangting@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6-minute walk distance (6MWD) (time frame: 8 weeks; 20 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.