Clinical trial NCT06235502: Long-term Home-based Exercise for Patients With COPD: the COPDtoParis Project
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Telerehabilitation
COPD
Quality of Life
Mobility Limitation
Lead sponsor: Aalborg University Hospital
Sponsor class: OTHER
Collaborators: name: Karen Elise Jensen Foundation
name: Simon Fougners Hartmann Family Foundation
name: 4Mvideo
name: SENS Innovation Aps
First posted: 2024-02-01
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Five-repetition sit-to-stand test
timeFrame: Baseline measurement at initation of intervention
measure: Five-repetition sit-to-stand test
timeFrame: Changes from baseline lower limb function at follow-up are assessed at 6 weeks
measure: Five-repetition sit-to-stand test
timeFrame: Changes from baseline lower limb function at follow-up are assessed at 6 months
measure: Five-repetition sit-to-stand test
timeFrame: Changes from baseline lower limb function at follow-up are assessed at 12 months
Secondary outcomes:
measure: Daily Activity Levels
timeFrame: Baseline measurement at initation of intervention
measure: Daily Activity Levels
timeFrame: Changes from baseline activity during rehabilitation at follow-up are assessed 12 months
measure: Lung function Test (FEV1)
timeFrame: Baseline measurement at initation of intervention
measure: Lung function Test (FEV1)
timeFrame: Changes from baseline lung function at follow-up are assessed at 6 weeks
measure: Lung function Test (FEV1)
timeFrame: Changes from baseline lung function at follow-up are assessed at 6 months
measure: Lung function Test (FEV1)
timeFrame: Changes from baseline lung function at follow-up are assessed at 12 months
measure: Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)
timeFrame: Baseline measurement at initation of intervention
measure: Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)
timeFrame: Changes from baseline and at follow-up are assessed at 6 weeks
measure: Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)
timeFrame: Changes from baseline and at follow-up are assessed at 6 months
measure: Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC)
timeFrame: Changes from baseline and at follow-up are assessed at 12 months
measure: Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Baseline measurement at initation of intervention
measure: Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Changes from baseline health related quality of life at follow-up are assessed at 6 weeks
measure: Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Changes from baseline health related quality of life at follow-up are assessed at 6 months
measure: Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ)
timeFrame: Changes from baseline health related quality of life at follow-up are assessed at 12 months
measure: Life-Space Assessment (LSA)
timeFrame: Baseline measurement at initation of intervention
measure: Life-Space Assessment (LSA)
timeFrame: Changes from baseline mobility at follow-up are assessed at 6 weeks
measure: Life-Space Assessment (LSA)
timeFrame: Changes from baseline mobility at follow-up are assessed at 6 months
measure: Life-Space Assessment (LSA)
timeFrame: Changes from baseline mobility at follow-up are assessed at 12 months
measure: COPD Assessment Test (CAT)
timeFrame: Baseline measurement at initation of intervention
measure: COPD Assessment Test (CAT)
timeFrame: Changes from baseline COPD impact at follow-up are assessed at 6 weeks
measure: COPD Assessment Test (CAT)
timeFrame: Changes from baseline COPD impact at follow-up are assessed at 6 months
measure: COPD Assessment Test (CAT)
timeFrame: Changes from baseline COPD impact at follow-up are assessed at 12 months
measure: Tilburg Frailty Indicator (TFI)
timeFrame: Baseline measurement at initation of intervention
measure: Tilburg Frailty Indicator (TFI)
timeFrame: Changes from baseline frailty at follow-up are assessed at 6 weeks
measure: Tilburg Frailty Indicator (TFI)
timeFrame: Changes from baseline frailty at follow-up are assessed at 6 months
measure: Tilburg Frailty Indicator (TFI)
timeFrame: Changes from baseline frailty at follow-up are assessed at 12 months
measure: Clinical Frailty Scale (CFS)
timeFrame: Baseline measurement at initation of intervention
measure: Clinical Frailty Scale (CFS)
timeFrame: Changes from baseline frailty at follow-up are assessed at 6 weeks
measure: Clinical Frailty Scale (CFS)
timeFrame: Changes from baseline frailty at follow-up are assessed at 6 months
measure: Clinical Frailty Scale (CFS)
timeFrame: Changes from baseline frailty at follow-up are assessed at 12 months
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Baseline measurement at initation of intervention
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Changes from baseline performance at follow-up are assessed at 6 weeks
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Changes from baseline performance at follow-up are assessed at 6 months
measure: Canadian Occupational Performance Measure (COPM)
timeFrame: Changes from baseline performance at follow-up are assessed at 12 months
measure: Six Minutes Walk Test (6MWT)
timeFrame: Baseline measurement at initation of intervention
measure: Six Minutes Walk Test (6MWT)
timeFrame: Changes from baseline mobility at follow-up are assessed at 6 weeks
measure: Six Minutes Walk Test (6MWT)
timeFrame: Changes from baseline mobility at follow-up are assessed at 6 months
measure: Six Minutes Walk Test (6MWT)
timeFrame: Changes from baseline and at follow-up are assessed at 12 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: Baseline measurement at initation of intervention
measure: Short Physical Performance Battery (SPPB)
timeFrame: Changes from baseline mobility at follow-ups are assessed at 6 weeks
measure: Short Physical Performance Battery (SPPB)
timeFrame: Changes from baseline mobility at follow-up are assessed at 6 months
measure: Short Physical Performance Battery (SPPB)
timeFrame: Changes from baseline mobility at follow-up are assessed at 12 months
measure: Readmissions
timeFrame: Readmissions are assessed at 12 months
measure: Survival rates
timeFrame: Mortality is assessed at 12 months
measure: EuroQol 5-Dimensions 5-Level (EQ-5D-5L)
timeFrame: Baseline measurement at initation of intervention
measure: EuroQol 5-Dimensions 5-Level (EQ-5D-5L)
timeFrame: Changes from baseline mobility at follow-ups are assessed at 6 weeks
measure: EuroQol 5-Dimensions 5-Level (EQ-5D-5L)
timeFrame: Changes from baseline mobility at follow-ups are assessed at 6 months
measure: EuroQol 5-Dimensions 5-Level (EQ-5D-5L)
timeFrame: Changes from baseline mobility at follow-up are assessed at 12 months
measure: 30 Seconds Sit To Stand Test
timeFrame: Baseline measurement at initation of intervention
measure: 30 Seconds Sit To Stand Test
timeFrame: Changes from baseline mobility at follow-ups are assessed at 6 weeks
measure: 30 Seconds Sit To Stand Test
timeFrame: Changes from baseline mobility at follow-ups are assessed at 6 months
measure: 30 Seconds Sit To Stand Test
timeFrame: Changes from baseline mobility at follow-ups are assessed at 12 months
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
Study officials:
affiliation: a.stoustrup@rn.dk
name: Anna L Stoustrup, MSc
role: PRINCIPAL_INVESTIGATOR
References: