TelerehabilitationCOPDtoParisNCT06235502
Long-term Home-based Exercise for Patients With COPD: the COPDtoParis Project
A study testing Home-based cycle-exercise for COPD patients in people with Telerehabilitation and COPD, run by Aalborg University Hospital at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Telerehabilitation, COPD, Quality of Life
- What is being tested?
- Home-based cycle-exercise for COPD patients
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Nov 2023to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Aalborg University Hospital
Aalborg, 9000
Anna L Stoustrup, MSc, +4520866747, a.stoustrup@rn.dk
Ulla M Weinreich, PhD, MD, 30687526, ulw@rn.dk
About this study
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
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.
Read the 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.
- Conditions
- Telerehabilitation, COPD, Quality of Life, Mobility Limitation
- Being tested
- Home-based cycle-exercise for COPD patients, Standard of Care
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Mobility Limitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-based cycle-exercise for COPD patientsOther
Patients will cycle in their own home using a pedal exerciser connected to the 4M-video app
Standard of CareOther
Exercise at Fitness Center, home based exercise according to a programme
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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 Receives: Other: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: Changes from baseline lower limb function at follow-up are assessed at 12 months
Secondary outcomes (52)
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.
Measured: Baseline measurement at initation of intervention
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
Measured: Changes from baseline activity during rehabilitation at follow-up are assessed 12 months
Lung function Test (FEV1)
Forced expiratory volume in the first second in a spirometry
Measured: Baseline measurement at initation of intervention
Lung function Test (FEV1)
Forced expiratory volume in the first second in a spirometry
Measured: Changes from baseline lung function at follow-up are assessed at 6 weeks
Lung function Test (FEV1)
Forced expiratory volume in the first second in a spirometry
Measured: Changes from baseline lung function at follow-up are assessed at 6 months
Lung function Test (FEV1)
Forced expiratory volume in the first second in a spirometry
Measured: 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)
A scale from 0-4 is used to assess the degree of functional disability due to dyspnoea. Higher score indicate higher degree of dyspnea
Measured: Baseline measurement at initation of intervention
Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)
A scale from 0-4 is used to assess the degree of functional disability due to dyspnoea. Higher score indicate higher degree of dyspnea
Measured: Changes from baseline and at follow-up are assessed at 6 weeks
Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)
A scale from 0-4 is used to assess the degree of functional disability due to dyspnoea. Higher score indicate higher degree of dyspnea
Measured: Changes from baseline and at follow-up are assessed at 6 months
Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)
A scale from 0-4 is used to assess the degree of functional disability due to dyspnoea. Higher score indicate higher degree of dyspnea
Measured: Changes from baseline and at follow-up are assessed at 12 months
Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)
The 2 part, 50 item questionnaire with scores from 0-100 is used to assess health impairment related to symptoms, activity, impacts, and total in patients with asthma and Chronic Obstructive Pulmonary Disease. Higher scores indicate better health related quality of life.
Measured: Baseline measurement at initation of intervention
Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)
The 2 part, 50 item questionnaire with scores from 0-100 is used to assess health impairment related to symptoms, activity, impacts, and total in patients with asthma and Chronic Obstructive Pulmonary Disease. Higher scores indicate better health related quality of life.
Measured: Changes from baseline health related quality of life at follow-up are assessed at 6 weeks
Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)
The 2 part, 50 item questionnaire with scores from 0-100 is used to assess health impairment related to symptoms, activity, impacts, and total in patients with asthma and Chronic Obstructive Pulmonary Disease. Higher scores indicate better health related quality of life.
Measured: Changes from baseline health related quality of life at follow-up are assessed at 6 months
Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)
The 2 part, 50 item questionnaire with scores from 0-100 is used to assess health impairment related to symptoms, activity, impacts, and total in patients with asthma and Chronic Obstructive Pulmonary Disease. Higher scores indicate better health related quality of life.
Measured: Changes from baseline health related quality of life at follow-up are assessed at 12 months
Life-Space Assessment (LSA)
Measure of performance on a range of tasks, ie. balance (score range = 0-16) and gait (score range = 0-12). Balance and gait scores are summed to produce a total score (range = 0-28) with higher scores indicate a higher degree of mobility.
Measured: Baseline measurement at initation of intervention
Life-Space Assessment (LSA)
Measure of performance on a range of tasks, ie. balance (score range = 0-16) and gait (score range = 0-12). Balance and gait scores are summed to produce a total score (range = 0-28) with higher scores indicate a higher degree of mobility.
Measured: Changes from baseline mobility at follow-up are assessed at 6 weeks
Life-Space Assessment (LSA)
Measure of performance on a range of tasks, ie. balance (score range = 0-16) and gait (score range = 0-12). Balance and gait scores are summed to produce a total score (range = 0-28) with higher scores indicate a higher degree of mobility.
Measured: Changes from baseline mobility at follow-up are assessed at 6 months
Life-Space Assessment (LSA)
Measure of performance on a range of tasks, ie. balance (score range = 0-16) and gait (score range = 0-12). Balance and gait scores are summed to produce a total score (range = 0-28) with higher scores indicate a higher degree of mobility.
Measured: Changes from baseline mobility at follow-up are assessed at 12 months
COPD Assessment Test (CAT)
Measurement of the impact of COPD on a person's life, and how this changes over time. Scale ranging from 5-30 where a higher score indicates a higher impact of COPD.
Measured: Baseline measurement at initation of intervention
COPD Assessment Test (CAT)
Measurement of the impact of COPD on a person's life, and how this changes over time. Scale ranging from 5-30 where a higher score indicates a higher impact of COPD.
Measured: Changes from baseline COPD impact at follow-up are assessed at 6 weeks
COPD Assessment Test (CAT)
Measurement of the impact of COPD on a person's life, and how this changes over time. Scale ranging from 5-30 where a higher score indicates a higher impact of COPD.
Measured: Changes from baseline COPD impact at follow-up are assessed at 6 months
COPD Assessment Test (CAT)
Measurement of the impact of COPD on a person's life, and how this changes over time. Scale ranging from 5-30 where a higher score indicates a higher impact of COPD.
Measured: Changes from baseline COPD impact at follow-up are assessed at 12 months
Tilburg Frailty Indicator (TFI)
Assessing multidimensional frailty among community-dwelling older people. Scale ranges from 0-15, with a score ranging from 0 to 8 for physical frailty, 0 to 4 for psychological frailty and 0 to 4 for social frailty. Higher scores refer to greater frailty, as older persons with a total TFI score ≥5 are considered to be frail.
Measured: Baseline measurement at initation of intervention
Tilburg Frailty Indicator (TFI)
Assessing multidimensional frailty among community-dwelling older people. Scale ranges from 0-15, with a score ranging from 0 to 8 for physical frailty, 0 to 4 for psychological frailty and 0 to 4 for social frailty. Higher scores refer to greater frailty, as older persons with a total TFI score ≥5 are considered to be frail.
Measured: Changes from baseline frailty at follow-up are assessed at 6 weeks
Tilburg Frailty Indicator (TFI)
Assessing multidimensional frailty among community-dwelling older people. Scale ranges from 0-15, with a score ranging from 0 to 8 for physical frailty, 0 to 4 for psychological frailty and 0 to 4 for social frailty. Higher scores refer to greater frailty, as older persons with a total TFI score ≥5 are considered to be frail.
Measured: Changes from baseline frailty at follow-up are assessed at 6 months
Tilburg Frailty Indicator (TFI)
Assessing multidimensional frailty among community-dwelling older people. Scale ranges from 0-15, with a score ranging from 0 to 8 for physical frailty, 0 to 4 for psychological frailty and 0 to 4 for social frailty. Higher scores refer to greater frailty, as older persons with a total TFI score ≥5 are considered to be frail.
Measured: Changes from baseline frailty at follow-up are assessed at 12 months
Clinical Frailty Scale (CFS)
Assessment of the overall level of fitness or frailty of an older adult. Scale ranges from 1-9 where a higher score indicates a higher degree of frailty.
Measured: Baseline measurement at initation of intervention
Clinical Frailty Scale (CFS)
Assessment of the overall level of fitness or frailty of an older adult. Scale ranges from 1-9 where a higher score indicates a higher degree of frailty.
Measured: Changes from baseline frailty at follow-up are assessed at 6 weeks
Clinical Frailty Scale (CFS)
Assessment of the overall level of fitness or frailty of an older adult. Scale ranges from 1-9 where a higher score indicates a higher degree of frailty.
Measured: Changes from baseline frailty at follow-up are assessed at 6 months
Clinical Frailty Scale (CFS)
Assessment of the overall level of fitness or frailty of an older adult. Scale ranges from 1-9 where a higher score indicates a higher degree of frailty.
Measured: Changes from baseline frailty at follow-up are assessed at 12 months
Canadian Occupational Performance Measure (COPM)
Qualitative outcome measure to assess a patients self-perception of performance in everyday living
Measured: Baseline measurement at initation of intervention
Canadian Occupational Performance Measure (COPM)
Qualitative outcome measure to assess a patients self-perception of performance in everyday living
Measured: Changes from baseline performance at follow-up are assessed at 6 weeks
Canadian Occupational Performance Measure (COPM)
Qualitative outcome measure to assess a patients self-perception of performance in everyday living
Measured: Changes from baseline performance at follow-up are assessed at 6 months
Canadian Occupational Performance Measure (COPM)
Qualitative outcome measure to assess a patients self-perception of performance in everyday living
Measured: Changes from baseline performance at follow-up are assessed at 12 months
Six Minutes Walk Test (6MWT)
A sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Baseline measurement at initation of intervention
Six Minutes Walk Test (6MWT)
a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Changes from baseline mobility at follow-up are assessed at 6 weeks
Six Minutes Walk Test (6MWT)
a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Changes from baseline mobility at follow-up are assessed at 6 months
Six Minutes Walk Test (6MWT)
a sub-maximal exercise test used to assess aerobic capacity and endurance. The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity.
Measured: Changes from baseline and at follow-up are assessed at 12 months
Short Physical Performance Battery (SPPB)
Measurement of balance, lower extremity strength, and functional capacity in older adults (>65 years of age). The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility.
Measured: Baseline measurement at initation of intervention
Short Physical Performance Battery (SPPB)
Measurement of balance, lower extremity strength, and functional capacity in older adults (>65 years of age). The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility.
Measured: Changes from baseline mobility at follow-ups are assessed at 6 weeks
Short Physical Performance Battery (SPPB)
Measurement of balance, lower extremity strength, and functional capacity in older adults (>65 years of age). The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility.
Measured: Changes from baseline mobility at follow-up are assessed at 6 months
Short Physical Performance Battery (SPPB)
Measurement of balance, lower extremity strength, and functional capacity in older adults (>65 years of age). The test includes three different domains (walking, sit-to-stand and balance) to assess functional mobility.
Measured: Changes from baseline mobility at follow-up are assessed at 12 months
Readmissions
From the electronic patient journal, data on number of participants who are readmitted, and number of individual readmissions, are collected
Measured: Readmissions are assessed at 12 months
Survival rates
From the electronic patient journal, potential deaths amongst participants are collected
Measured: Mortality is assessed at 12 months
EuroQol 5-Dimensions 5-Level (EQ-5D-5L)
The EQ-5D-5L test assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels ranging from "no problems" to "extreme problems." Patients select the level that best describes their health, resulting in a 5-digit number representing their health state. The EQ VAS is a separate measure where patients rate their overall health on a scale from "the best health you can imagine" to "the worst health you can imagine."
Measured: Baseline measurement at initation of intervention
EuroQol 5-Dimensions 5-Level (EQ-5D-5L)
The EQ-5D-5L test assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels ranging from "no problems" to "extreme problems." Patients select the level that best describes their health, resulting in a 5-digit number representing their health state. The EQ VAS is a separate measure where patients rate their overall health on a scale from "the best health you can imagine" to "the worst health you can imagine."
Measured: Changes from baseline mobility at follow-ups are assessed at 6 weeks
EuroQol 5-Dimensions 5-Level (EQ-5D-5L)
The EQ-5D-5L test assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels ranging from "no problems" to "extreme problems." Patients select the level that best describes their health, resulting in a 5-digit number representing their health state. The EQ VAS is a separate measure where patients rate their overall health on a scale from "the best health you can imagine" to "the worst health you can imagine."
Measured: Changes from baseline mobility at follow-ups are assessed at 6 months
EuroQol 5-Dimensions 5-Level (EQ-5D-5L)
The EQ-5D-5L test assesses health across five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels ranging from "no problems" to "extreme problems." Patients select the level that best describes their health, resulting in a 5-digit number representing their health state. The EQ VAS is a separate measure where patients rate their overall health on a scale from "the best health you can imagine" to "the worst health you can imagine."
Measured: Changes from baseline mobility at follow-up are assessed at 12 months
30 Seconds Sit To Stand Test
Assessment of mobility and functional capacity, particularly in older adults or individuals with mobility impairments that measures lower body strength and endurance. The patient is asked to sit in a chair with their arms crossed over their chest and then stand up and sit down as many times as possible within 30 seconds. The total number of complete stands is recorded as the score.
Measured: Baseline measurement at initation of intervention
30 Seconds Sit To Stand Test
Assessment of mobility and functional capacity, particularly in older adults or individuals with mobility impairments that measures lower body strength and endurance. The patient is asked to sit in a chair with their arms crossed over their chest and then stand up and sit down as many times as possible within 30 seconds. The total number of complete stands is recorded as the score.
Measured: Changes from baseline mobility at follow-ups are assessed at 6 weeks
30 Seconds Sit To Stand Test
Assessment of mobility and functional capacity, particularly in older adults or individuals with mobility impairments that measures lower body strength and endurance. The patient is asked to sit in a chair with their arms crossed over their chest and then stand up and sit down as many times as possible within 30 seconds. The total number of complete stands is recorded as the score.
Measured: Changes from baseline mobility at follow-ups are assessed at 6 months
30 Seconds Sit To Stand Test
Assessment of mobility and functional capacity, particularly in older adults or individuals with mobility impairments that measures lower body strength and endurance. The patient is asked to sit in a chair with their arms crossed over their chest and then stand up and sit down as many times as possible within 30 seconds. The total number of complete stands is recorded as the score.
Measured: Changes from baseline mobility at follow-ups are assessed at 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start1 Nov 2023
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for TelerehabilitationStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aalborg University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Karen Elise Jensen Foundation, Simon Fougners Hartmann Family Foundation, 4Mvideo, SENS Innovation Aps
- Responsible party
- Principal investigator, Anna Lei Stoustrup, Aalborg University Hospital
- Investigators
- Anna L Stoustrup, MSc, Principal investigator, a.stoustrup@rn.dk
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06235502
- Sponsor's protocol ID
- COPDtoParis
- Acronym
- COPDtoParis
- Status last verified
- Dec 2024
- First submitted
- 1 May 2023
- Last updated
- 4 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data are accessible through enquiry to principal investigator
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.
PubMed 39832888
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06235502
- Acronym / sponsor ID
- COPDtoParis / COPDtoParis
- Conditions
- Telerehabilitation, COPD, Quality of Life, Mobility Limitation
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Aalborg University HospitalUniversity, hospital or other
- Collaborators
- Karen Elise Jensen Foundation, Simon Fougners Hartmann Family Foundation, 4Mvideo, SENS Innovation Aps
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 1 Feb 2024 (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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Home-based, longterm cycle-exercise | Experimental | Other: Home-based cycle-exercise for COPD patientsOne year home-based cycle exercise on a exercise bike connected to a video app from where participants can cycle push videos forward when cycling. |
| Standard of Care | Active comparator | Other: Standard of CareStandard of Care; exercise at fitness center, home-based exercise according to programme, self-initiated exercise |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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.
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 cycle-exercise for COPD patientsPatients will cycle in their own home using a pedal exerciser connected to the 4M-video app | Other | Home-based, longterm cycle-exercise |
| Standard of CareExercise at Fitness Center, home based exercise according to a programme | Other | Standard of Care |
Primary outcome
Five-repetition sit-to-stand test
Time frame: Baseline measurement at initation of intervention
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
Five-repetition sit-to-stand test
Time frame: Changes from baseline lower limb function at follow-up are assessed at 6 weeks
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
Five-repetition sit-to-stand test
Time frame: Changes from baseline lower limb function at follow-up are assessed at 6 months
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
Five-repetition sit-to-stand test
Time frame: Changes from baseline lower limb function at follow-up are assessed at 12 months
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
52 secondary outcomes
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
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 months
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 12 months
Life-Space Assessment (LSA)
Time frame: Baseline measurement at initation of intervention
Life-Space Assessment (LSA)
Time frame: Changes from baseline mobility at follow-up are assessed at 6 weeks
Life-Space Assessment (LSA)
Time frame: Changes from baseline mobility at follow-up are assessed at 6 months
Life-Space Assessment (LSA)
Time frame: Changes from baseline mobility at follow-up are assessed at 12 months
COPD Assessment Test (CAT)
Time frame: Baseline measurement at initation of intervention
COPD Assessment Test (CAT)
Time frame: Changes from baseline COPD impact at follow-up are assessed at 6 weeks
COPD Assessment Test (CAT)
Time frame: Changes from baseline COPD impact at follow-up are assessed at 6 months
COPD Assessment Test (CAT)
Time frame: Changes from baseline COPD impact at follow-up are assessed at 12 months
Tilburg Frailty Indicator (TFI)
Time frame: Baseline measurement at initation of intervention
Tilburg Frailty Indicator (TFI)
Time frame: Changes from baseline frailty at follow-up are assessed at 6 weeks
Tilburg Frailty Indicator (TFI)
Time frame: Changes from baseline frailty at follow-up are assessed at 6 months
Tilburg Frailty Indicator (TFI)
Time frame: Changes from baseline frailty at follow-up are assessed at 12 months
Clinical Frailty Scale (CFS)
Time frame: Baseline measurement at initation of intervention
Clinical Frailty Scale (CFS)
Time frame: Changes from baseline frailty at follow-up are assessed at 6 weeks
Clinical Frailty Scale (CFS)
Time frame: Changes from baseline frailty at follow-up are assessed at 6 months
Clinical Frailty Scale (CFS)
Time frame: Changes from baseline frailty at follow-up are assessed at 12 months
Canadian Occupational Performance Measure (COPM)
Time frame: Baseline measurement at initation of intervention
Canadian Occupational Performance Measure (COPM)
Time frame: Changes from baseline performance at follow-up are assessed at 6 weeks
Canadian Occupational Performance Measure (COPM)
Time frame: Changes from baseline performance at follow-up are assessed at 6 months
Canadian Occupational Performance Measure (COPM)
Time frame: Changes from baseline performance at follow-up are assessed at 12 months
Six Minutes Walk Test (6MWT)
Time frame: Baseline measurement at initation of intervention
Six Minutes Walk Test (6MWT)
Time frame: Changes from baseline mobility at follow-up are assessed at 6 weeks
Six Minutes Walk Test (6MWT)
Time frame: Changes from baseline mobility at follow-up are assessed at 6 months
Six Minutes Walk Test (6MWT)
Time frame: Changes from baseline and at follow-up are assessed at 12 months
Short Physical Performance Battery (SPPB)
Time frame: Baseline measurement at initation of intervention
Short Physical Performance Battery (SPPB)
Time frame: Changes from baseline mobility at follow-ups are assessed at 6 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2024.
- Derived from this study: PubMed 39832888Stoustrup 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.
- Individual participant dataSharing planned: Yes. Data are accessible through enquiry to principal investigator
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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.
Anna L Stoustrup, MSc principal investigator
a.stoustrup@rn.dk
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 cycle-exercise for COPD patients in people with Telerehabilitation and COPD, run by Aalborg University Hospital at 1 site in Denmark.
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 5 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 4 Dec 2024. 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 Denmark. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Anna L Stoustrup, MSc (+45 52505879, a.stoustrup@rn.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Five-repetition sit-to-stand test (time frame: Baseline measurement at initation of intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06235502, which also lists 1 linked publication.
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 4 Dec 2024.