Long-term Home-based Exercise for Patients With COPD: the COPDtoParis Project
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorAalborg University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Home-based cycle-exercise for COPD patients
Other interventionPatients will cycle in their own home using a pedal exerciser connected to the 4M-video app
Standard of Care
Other interventionExercise at Fitness Center, home based exercise according to a programme
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: Home-based, longterm cycle-exerciseExperimental treatment 1 intervention
Group B: Standard of CareActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
Time frame
Baseline measurement at initation of intervention2
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
Time frame
Changes from baseline lower limb function at follow-up are assessed at 6 weeks3
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
Time frame
Changes from baseline lower limb function at follow-up are assessed at 6 months4
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
Time frame
Changes from baseline lower limb function at follow-up are assessed at 12 monthsSecondary outcomes
1
Daily Activity Levels
Triaxial leg-mounted sensor that assesses time spent standing, walking, running, supine, cycling and sleeping/sedentary continuously throughout the day during post-hospitalisation rehabilitation for 6 weeks.
Time frame
Baseline measurement at initation of intervention2
Daily Activity Levels
Triaxial leg-mounted sensor that assesses time spent standing, walking, running, supine, cycling and sleeping/sedentary continuously throughout the day during post-hospitalisation rehabilitation for 6 weeks
Time frame
Changes from baseline activity during rehabilitation at follow-up are assessed 12 months3
Lung function Test (FEV1)
Forced expiratory volume in the first second in a spirometry
Time frame
Baseline measurement at initation of intervention4
Lung function Test (FEV1)
Forced expiratory volume in the first second in a spirometry
Time frame
Changes from baseline lung function at follow-up are assessed at 6 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Aalborg University Hospital
Lead sponsor
Karen Elise Jensen Foundation
Collaborator
Simon Fougners Hartmann Family Foundation
Collaborator
4Mvideo
Collaborator
SENS Innovation Aps
Collaborator
Source ClinicalTrials.gov