Long-term Home-based Exercise for Patients With COPD: the COPDtoParis Project
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Home-based cycle-exercise for COPD patients, Standard of Care.
- Who it may be relevant to
- Registry conditions: Telerehabilitation, COPD, Quality of Life, Mobility Limitation. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Denmark
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Cluster Randomised Controlled Trial on the Effects of Long-term Home-based Exercise for Patients With Chronic Obstructive Pulmonary Disease With Recent Exacerbation: the COPDtoParis Project
Overview
This randomised controlled trial (RCT) aims to investigate the effect of long-term, interactive home-based cycle-exercise on patients with Chronic Obstructive Pulmonary Disease (COPD) after a COPD exacerbation requiring hospitalisation. The investigators aim to investigate if patients can maintain or improve the effects of pulmonary rehabilitation in terms of walking distance, intensity of COPD symptoms, health related quality of life and Quality Adjusted Life-Years. Participants will cycle on a pedal-exerciser in the comfort of staying in the participants' own home, whilst getting visual feedback from the 4Mvideo app. The 4Mvideo technology is a Danish designed software system, where users can cycle forward a recording of a cyclist by treading on a pedal-exerciser, thereby getting some of the experience of a real-life cycling trip at home. The investigators will compare the clinical outcomes and daily activity levels with that of a control group consisting of COPD patients.
Detailed description
Patients with chronic obstructive pulmonary disease (COPD) have a higher risk of experiencing disability, and even though participating in pulmonary rehabilitation (PR) are efficient for regaining strength, function and relieving symptoms, effects prove difficult to maintain. Furthermore, physical attendance to outpatient PR is challenging for COPD patients, many of whom are bound to their home, due to said disability and symptoms. Even in patients who follow through with the PR programme, adherence to exercise after is a major challenge.
The investigators hypothesise that an intervention group of COPD-patients, who will receive home-based cycle exercise will maintain or even improve effects on physical fitness from PR, in terms of walking distance, daily activity levels (DAL), exercise tolerance, disease prevention and health related quality of life (HRQoL).
Furthermore, the investigators hypothesise that the participants express improved motivation in terms of adhering to exercise, when participating in home-based, interactive group cycle exercise.
It is expected to measure changes in DAL, lung function, levels of dyspnoea, exercise tolerance, walking distance, mobility, COPD symptoms, activity of daily living (ADL) related performance and HRQoL of the participants, along with assessing disease prevention. Data is compared intrapersonal and in-between groups to identify differences in outcomes at an individual level, and between intervention- and control group. Furthermore, the investigators expect to uncover identifiable in-depth insights into the values and beliefs towards exercising amongst participants.
40 participants are recruited amongst COPD patients that live in Aalborg Municipality and are admitted at Aalborg University Hospital, hospitalised due to acute exacerbation of COPD. After being discharged participants are referred to rehabilitation, for most in their own home. After rehabilitation participants are randomized into either intervention group who will exercise on exercise bikes connected with tablets in their own home. The control group will receive usual care, which consists of offers of exercising in their own home according to a programme or participating in exercise at a facility center.
Interventions
- Other Home-based cycle-exercise for COPD patients
Patients will cycle in their own home using a pedal exerciser connected to the 4M-video app - Other Standard of Care
Exercise at Fitness Center, home based exercise according to a programme
Primary outcome measures
- Five-repetition sit-to-stand test [Time frame: Baseline measurement at initation of intervention]
- Five-repetition sit-to-stand test [Time frame: Changes from baseline lower limb function at follow-up are assessed at 6 weeks]
- Five-repetition sit-to-stand test [Time frame: Changes from baseline lower limb function at follow-up are assessed at 6 months]
- Five-repetition sit-to-stand test [Time frame: Changes from baseline lower limb function at follow-up are assessed at 12 months]
Secondary outcome measures (12)
- Daily Activity Levels [Time frame: Baseline measurement at initation of intervention]
- Daily Activity Levels [Time frame: Changes from baseline activity during rehabilitation at follow-up are assessed 12 months]
- Lung function Test (FEV1) [Time frame: Baseline measurement at initation of intervention]
- Lung function Test (FEV1) [Time frame: Changes from baseline lung function at follow-up are assessed at 6 weeks]
- Lung function Test (FEV1) [Time frame: Changes from baseline lung function at follow-up are assessed at 6 months]
- Lung function Test (FEV1) [Time frame: Changes from baseline lung function at follow-up are assessed at 12 months]
- Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC) [Time frame: Baseline measurement at initation of intervention]
- Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC) [Time frame: Changes from baseline and at follow-up are assessed at 6 weeks]
- Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC) [Time frame: Changes from baseline and at follow-up are assessed at 6 months]
- Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC) [Time frame: Changes from baseline and at follow-up are assessed at 12 months]
- Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ) [Time frame: Baseline measurement at initation of intervention]
- Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ) [Time frame: Changes from baseline health related quality of life at follow-up are assessed at 6 weeks]
Eligibility criteria
Inclusion criteria
- Adults at age > 18 years old
- Hospital admission with COPD exacerbation with pre-existing COPD diagnosis
- Citizens of Aalborg Municipality
- Able to provide informed consent
- Accepting of referral to rehabilitation
Exclusion criteria
- Terminal illness
- Unstable heart disease, i.e., ischemic heart disease, cardiac rhythm disorders
- Other conditions preventing participating in cycle exercise, e.g., amputation, regimens or earlier or upcoming surgeries preventing seated position, blindness
- Inability to understand basic Danish oral and written information or giving informed consent.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Denmark · 1 center
- Aalborg University Hospital — Aalborg
Publications
- Stoustrup AL, Thomsen LP, Andreasen J, Palsson TS, Weinreich UM. Cluster randomised controlled trial on the effects of long-term home-based exercise for patients with chronic obstructive pulmonary disease with recent exacerbation: research protocol of the COPDtoParis Project. BMJ Open Respir Res. 2025 Jan 19;12(1):e002573. doi: 10.1136/bmjresp-2024-002573. PMID 39832888
Identifiers
NCT: NCT06235502 · COPDtoParis