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| Name | Class |
|---|---|
| Karen Elise Jensen Foundation | OTHER |
| Simon Fougners Hartmann Family Foundation | UNKNOWN |
| 4Mvideo | UNKNOWN |
| SENS Innovation Aps |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Standard of Care | Active Comparator | Standard of Care; exercise at fitness center, home-based exercise according to programme, self-initiated exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline measurement at initation of intervention |
| Daily Activity Levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Anna L Stoustrup, MSc | Contact | +45 52505879 | a.stoustrup@rn.dk | |
| Ulla M Weinreich, PhD | Contact | +45 30687526 | ulw@rn.dk |
| Name | Affiliation | Role |
|---|---|---|
| Anna L Stoustrup, MSc | a.stoustrup@rn.dk | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Aalborg University Hospital | Recruiting | Aalborg | 9000 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39832888 | Derived | 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. |
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Data are accessible through enquiry to principal investigator
01/09/2025
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D051346 | Mobility Limitation |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| UNKNOWN |
Randomized Controlled Trial
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Participants are anonymised with a participant identification
| Standard of Care | Other | Exercise at Fitness Center, home based exercise according to a programme |
|
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 |
| 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 | Baseline measurement at initation of intervention |
| Lung function Test (FEV1) | Forced expiratory volume in the first second in a spirometry | 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 | 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 | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | 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 | 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 | 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 | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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 | Readmissions are assessed at 12 months |
| Survival rates | From the electronic patient journal, potential deaths amongst participants are collected | 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." | 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." | 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." | 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." | 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. | 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. | 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. | 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. | Changes from baseline mobility at follow-ups are assessed at 12 months |
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |