Long-term Home-based Exercise for Patients With COPD: the COPDtoParis Project

NCT06235502 | Recruiting

• 1 other identifier: COPDtoParis
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Telerehabilitation; COPD; Quality of Life; Mobility Limitation

Outcome Measures

Primary Outcomes (4)

• Five-repetition sit-to-stand test

  The five-repetition sit-to-stand test is a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded

  Baseline measurement at initation of intervention

• Five-repetition sit-to-stand test

  The five-repetition sit-to-stand test is a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded

  Changes from baseline lower limb function at follow-up are assessed at 6 weeks

• Five-repetition sit-to-stand test

  The five-repetition sit-to-stand test is a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded

  Changes from baseline lower limb function at follow-up are assessed at 6 months

• Five-repetition sit-to-stand test

  The five-repetition sit-to-stand test is a test of lower limb function that measures the fastest time taken to stand five times from a chair with arms folded

  Changes from baseline lower limb function at follow-up are assessed at 12 months

Secondary Outcomes (52)

• Daily Activity Levels

  Baseline measurement at initation of intervention

• Daily Activity Levels

  Changes from baseline activity during rehabilitation at follow-up are assessed 12 months

• Lung function Test (FEV1)

  Baseline measurement at initation of intervention

• Lung function Test (FEV1)

  Changes from baseline lung function at follow-up are assessed at 6 weeks

• Lung function Test (FEV1)

  Changes from baseline lung function at follow-up are assessed at 6 months

Study Arms (2)

Home-based, longterm cycle-exercise

EXPERIMENTAL

One year home-based cycle exercise on a exercise bike connected to a video app from where participants can cycle push videos forward when cycling.

Other: Home-based cycle-exercise for COPD patients

Standard of Care

ACTIVE COMPARATOR

Standard of Care; exercise at fitness center, home-based exercise according to programme, self-initiated exercise

Other: Standard of Care

Interventions

Home-based cycle-exercise for COPD patients OTHER

Patients will cycle in their own home using a pedal exerciser connected to the 4M-video app

Home-based, longterm cycle-exercise

Standard of Care OTHER

Exercise at Fitness Center, home based exercise according to a programme

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University Hospital: lead
• Karen Elise Jensen Foundation: collaborator
• Simon Fougners Hartmann Family Foundation: collaborator
• 4Mvideo: collaborator
• SENS Innovation Aps: collaborator

Study Sites (1)

Aalborg University Hospital

Aalborg, 9000, Denmark

RECRUITING

Related Publications (1)

• 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 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Mobility Limitation

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Anna L Stoustrup, MSc

  a.stoustrup@rn.dk

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Anna L Stoustrup, MSc

CONTACT

+45 52505879; a.stoustrup@rn.dk

Ulla M Weinreich, PhD

CONTACT

+45 30687526; ulw@rn.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Participants are anonymised with a participant identification
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Fellow

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: May 1, 2023
• First Posted: February 1, 2024
• Study Start: November 1, 2023
• Primary Completion: September 1, 2025
• Study Completion: September 1, 2025
• Last Updated: December 4, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 01/09/2025

Locations

DK (1)