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

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.

Study Overview

• Status: Recruiting
• Conditions: Quality of Life; Telerehabilitation; COPD; Mobility Limitation
• Intervention / Treatment: Other: Home-based cycle-exercise for COPD patients; Other: Standard of Care

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 Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna L Stoustrup, MSc; Phone Number: +45 52505879; Email: a.stoustrup@rn.dk
• Study Contact Backup: Name: Ulla M Weinreich, PhD; Phone Number: +45 30687526; Email: ulw@rn.dk

Study Locations

• Denmark
  • Aalborg, Denmark, 9000
    • Recruiting
    • Aalborg University Hospital
    • Contact: Anna L Stoustrup, MSc; Phone Number: +4520866747; Email: a.stoustrup@rn.dk
    • Contact: Ulla M Weinreich, PhD, MD; Phone Number: 30687526; Email: ulw@rn.dk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based, longterm cycle-exercise; One year home-based cycle exercise on a exercise bike connected to a video app from where participants can cycle push videos forward when cycling.	Other: Home-based cycle-exercise for COPD patients; Patients will cycle in their own home using a pedal exerciser connected to the 4M-video app
Active Comparator: Standard of Care; Standard of Care; exercise at fitness center, home-based exercise according to programme, self-initiated exercise	Other: Standard of Care; Exercise at Fitness Center, home based exercise according to a programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Aalborg University Hospital
• Collaborators: Karen Elise Jensen Foundation; SENS Innovation Aps; Simon Fougners Hartmann Family Foundation; 4Mvideo
• Investigators: Principal Investigator: Anna L Stoustrup, MSc, a.stoustrup@rn.dk

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2023
• Primary Completion (Estimated): September 1, 2025
• Study Completion (Estimated): September 1, 2025

Study Registration Dates

• First Submitted: May 1, 2023
• First Submitted That Met QC Criteria: January 31, 2024
• First Posted (Actual): February 1, 2024

Study Record Updates

• Last Update Posted (Estimated): December 4, 2024
• Last Update Submitted That Met QC Criteria: December 2, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mobility Limitation
• Other Study ID Numbers: COPDtoParis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Data are accessible through enquiry to principal investigator
• IPD Sharing Time Frame: 01/09/2025
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No