ClinicalTrials.gg
Status unknownNCT06085261COPDMUSTUpdated Oct 16, 2023

COPD: A Multi-center Supervised Tele-rehabilitation Study

An interventional study of home-based telerehabilitation group and center-based traditional rehabilitation group in Chronic Obstructive Pulmonary Disease, sponsored by China-Japan Friendship Hospital. Status unknown at 1 site in China. Open to participants aged 40 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-16.

Sponsored by China-Japan Friendship Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
360
Allocation
Non-randomized
Ages
40 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Chronic Obstructive Pulmonary Disease

Keywords

  • COPD
  • pulmonary rehabilitation
  • tele-rehabilitation
03

In context

Pulmonary Disease, Chronic Obstructive

4,253 studies on the registry are indexed under Pulmonary Disease, Chronic Obstructive; 707 are open to participants now.

This study's planned enrollment of 360 is above the median of 70 across 3,008 interventional studies indexed under Pulmonary Disease, Chronic Obstructive.

Browse Pulmonary Disease, Chronic Obstructive studies →

Lead sponsor

China-Japan Friendship Hospital is the lead sponsor of 177 studies on the registry; 110 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
40 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
360 participants (estimated)

Study arms

  • 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

  • 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

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.

06

What researchers measure

Primary outcomes

  1. 6-minute walk distance (6MWD)

    6-minute walk distance

    Time frame: 8 weeks; 20 weeks

Secondary outcomes

  1. pulmonary function

    forced expiratory volume in 1 second (FEV1) \[velocity\]

    Time frame: 8 weeks; 20 weeks

  2. pulmonary function

    ratio between FEV1 and forced vital capacity (FEV1/FVC) \[velocity\]

    Time frame: 8 weeks; 20 weeks

  3. pulmonary function

    forced expiratory flow between 25 and 75% of forced vital capacity (FEF25-75%) \[velocity\]

    Time frame: 8 weeks; 20 weeks

  4. pulmonary function

    inspiratory capacity (IC) \[velocity\]

    Time frame: 8 weeks; 20 weeks

  5. pulmonary function

    residual volume (RV) \[velocity\]

    Time frame: 8 weeks; 20 weeks

  6. pulmonary function

    total lung capacity (TLC) \[velocity\]

    Time frame: 8 weeks; 20 weeks

  7. pulmonary function

    diffusing capacity of the lung for carbon monoxide (DLCO) \[velocity\]

    Time frame: 8 weeks; 20 weeks

  8. Respiratory muscle strength

    maximum inspiratory pressure(MIP), maximum expiratory pressure(MEP)

    Time frame: 8 weeks; 20 weeks

  9. Short Physical Performance Battery(SPPB)

    Test for health-related physical performance

    Time frame: 8 weeks; 20 weeks

  10. modified British medical research council(mMRC)

    It is a self-reported symptom questionnaire ranging from 0-4 score, higher scores mean a worse outcome.

    Time frame: 8 weeks; 20 weeks

  11. COPD assessment test(CAT)

    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

  12. St. George's Respiratory Questionnaire (SGRQ)

    It is a self-reported symptom questionnaire ranging from 0-100 score, higher scores mean a worse outcome.

    Time frame: 8 weeks; 20 weeks

  13. 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.

    Time frame: 8 weeks; 20 weeks

07

Study locations

1 site
  • China-Japan Friendship hospital
    Beijing, China
    • Shiwei Qumu · Contact
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2023; primary completion for Aug 2024, 9 months later.

Of 796 non-industry interventional studies with no phase under Pulmonary Disease, Chronic Obstructive, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 45. This study's planned 9 months is below that.

Counting every sponsor, half of 848 studies reached it within 24 months; a quarter within 11 and three quarters within 42.

How these figures are worked out, and which studies are left out of them.

Registered
Aug 6, 2023
First posted
Oct 16, 2023
StartEst.
Nov 2023
Primary completionEst.
Aug 2024
CompletionEst.
Dec 2024
Last update
Oct 16, 2023
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 16, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06085261
Responsible party
Ting YANG (Principal Investigator, Clinical Professor, China-Japan Friendship Hospital) — Principal investigator
First posted
Oct 16, 2023
Start date
Nov 2023 (estimated)
Primary completion
Aug 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Oct 16, 2023

Study contacts

Ting Yang, MD
Contact
zryyyangting@163.com
84206272
Shiwei Qumu, Dr
study director · China-Japan Friendship Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2023. You cannot join it, but the record below documents what was studied.

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