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

A

Aalborg University Hospital

Status

Enrolling

Conditions

Telerehabilitation
Quality of Life
COPD
Mobility Limitation

Treatments

Other: Standard of Care
Other: Home-based cycle-exercise for COPD patients

Study type

Interventional

Funder types

Other

Identifiers

NCT06235502
COPDtoParis

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

40 participants in 2 patient groups

Home-based, longterm cycle-exercise
Experimental group
Description:
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.
Treatment:
Other: Home-based cycle-exercise for COPD patients
Standard of Care
Active Comparator group
Description:
Standard of Care; exercise at fitness center, home-based exercise according to programme, self-initiated exercise
Treatment:
Other: Standard of Care

Trial contacts and locations

1

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Central trial contact

Anna L Stoustrup, MSc; Ulla M Weinreich, PhD

Data sourced from clinicaltrials.gov

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