Tele-rehabilitation to Maintain Function and Health: COPD Patients on Bike to Paris

Quality of Life Clinical Trial

— COPDParis  

Official title:

Vedligeholdende og Forebyggende Holdbaseret hjemmetræning: KOL-patienter Cykler Til Paris English: Tele-rehabilitation to Maintain Function and Health: COPD Patients on Bike to Paris

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06235502
• Other study ID #: COPDParis
• Status: Recruiting
• Phase: N/A
• Start date: November 1, 2023
• Est. completion date: May 31, 2025

Study information

• Verified date: January 2024
• Source: Aalborg University Hospital
• Contact: Anna L Stoustrup, MSc
• Phone: +45 52505879
• Email: a.stoustrup[@]rn.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: May 31, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults at age > 18 years old

• Patients with an established diagnosis of COPD, admitted to Aalborg University Hospital for AECOPD

• Citizens of Aalborg Municipality

• Accepting of referral to PR

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.

Related Conditions & MeSH terms

• COPD
• Mobility Limitation
• Quality of Life
• Telerehabilitation

Intervention

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
• Standard of Care
Exercise at Fitness Center, home based exercise according to a programme

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg

Sponsors (5)

Lead Sponsor	Collaborator
Aalborg University Hospital	4Mvideo, Karen Elise Jensen Foundation, SENS Innovation Aps, Simon Fougners Hartmann Family Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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 3 months
Primary	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 5 months
Primary	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 9 months
Primary	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 15 months
Primary	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 3 months
Primary	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 5 months
Primary	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 9 months
Primary	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 15 months
Secondary	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.	Changes from baseline activity during rehabilitation at follow-up are assessed 9 months
Secondary	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	Changes from baseline activity during rehabilitation at follow-up are assessed 15 months
Secondary	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 3 months
Secondary	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 5 months
Secondary	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 9 months
Secondary	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 15 months
Secondary	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 3 months
Secondary	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 5 months
Secondary	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 9 months
Secondary	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 15 months
Secondary	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 3 months
Secondary	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 5 months
Secondary	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 9 months
Secondary	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 15 months
Secondary	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 3 months
Secondary	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 5 months
Secondary	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 9 months
Secondary	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 15 months
Secondary	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 3 months
Secondary	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 5 months
Secondary	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 9 months
Secondary	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 15 months
Secondary	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 3 months
Secondary	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 5 months
Secondary	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 9 months
Secondary	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 15 months
Secondary	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 3 months
Secondary	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 5 months
Secondary	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 9 months
Secondary	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 15 months
Secondary	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 3 months
Secondary	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 5 months
Secondary	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 9 months
Secondary	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 15 months