COPD, Mobility Limitation, Quality of Life, Telerehabilitation
Conditions
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.
Interventions
OTHERHome-based cycle-exercise for COPD patients
Patients will cycle in their own home using a pedal exerciser connected to the 4M-video app
OTHERStandard of Care
Exercise at Fitness Center, home based exercise according to a programme
Sponsors
Karen Elise Jensen Foundation
Simon Fougners Hartmann Family Foundation
4Mvideo
SENS Innovation Aps
Aalborg University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
Participants are anonymised with a participant identification
Intervention model description
Randomized Controlled Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Five-repetition sit-to-stand test | Baseline measurement at initation of intervention | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung function Test (FEV1) | Baseline measurement at initation of intervention | Forced expiratory volume in the first second in a spirometry |
| Level of Dyspnea with the Modified Medical Research Council Dyspnoea Scale (mMRC) | Baseline measurement at initation of intervention | A scale from 0-4 is used to assess the degree of functional disability due to dyspnoea. Higher score indicate higher degree of dyspnea |
| Health Related Quality of Life with St. George's Respiratory Questionnaire (SGRQ) | Baseline measurement at initation of intervention | 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. |
| Six Minutes Walk Test (6MWT) | Baseline measurement at initation of intervention | 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. |
| Life-Space Assessment (LSA) | Baseline measurement at initation of intervention | 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. |
| COPD Assessment Test (CAT) | Baseline measurement at initation of intervention | 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. |
| Tilburg Frailty Indicator (TFI) | Baseline measurement at initation of intervention | 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. |
| Daily Activity Levels | Baseline measurement at initation of intervention | 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. |
| Canadian Occupational Performance Measure (COPM) | Baseline measurement at initation of intervention | Qualitative outcome measure to assess a patients self-perception of performance in everyday living |
| Short Physical Performance Battery (SPPB) | Baseline measurement at initation of intervention | 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. |
| Readmissions | Readmissions are assessed at 12 months | From the electronic patient journal, data on number of participants who are readmitted, and number of individual readmissions, are collected |
| Survival rates | Mortality is assessed at 12 months | From the electronic patient journal, potential deaths amongst participants are collected |
| EuroQol 5-Dimensions 5-Level (EQ-5D-5L) | Baseline measurement at initation of intervention | 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. |
| 30 Seconds Sit To Stand Test | Baseline measurement at initation of intervention | 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. |
| Clinical Frailty Scale (CFS) | Baseline measurement at initation of intervention | 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. |
Countries
Denmark
Contacts
Primary ContactAnna L Stoustrup, MSc
Backup ContactUlla M Weinreich, PhD
Outcome results
None listed