The Role of Home-monitoring in the Adherence of Patients With Chronic Obstructive Pulmonary Disease to Long-term Rehabilitation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change in physical activity levels
Study Overview
Brief Summary
The aim of this randomized controlled trial is to investigate the effects of adding PA monitoring and regular feedback of a pedometer (step counter) to an outpatient pulmonary rehabilitation (PR) program on daily PA levels and health status of patients with COPD.
Patients will be randomized to either receive a PR program with PA monitoring and regular feedback of a pedometer (experimental group [EG]) or a PR program alone (control group [CG]). During the PR program, patients in the EG will receive a pedometer to self-monitor their PA and individualized step-count goals. They will continue to use the pedometers and receive individualized goals for 3 months after the program.
It is expected that, by receiving individualized goals and a simple pedometer to self-monitor their PA during and after a PR program, patients with COPD will become more active and adhere to long-term rehabilitation, thus reducing the overall impact of COPD.
Detailed Description
Patients with Chronic Obstructive Pulmonary Disease (COPD) present lower levels of physical activity (PA), which have been associated with increased healthcare utilization and reduced survival. Thus, optimizing PA levels has become one therapeutic priority in COPD management.
Pulmonary rehabilitation (PR) is an effective intervention in reducing symptoms and improving patients' functional status and quality of life. However, its effects in increasing patients' physical activity (PA) levels are limited. Previous research has suggested that PR with continuous PA monitoring with feedback may be a suitable approach to increase and maintain patients' PA levels.
Patients who agree to participate will be randomized to either receive a PR program with PA monitoring and regular feedback of a pedometer (experimental group [EG]) or a PR program alone (control group [CG]). Both PR programs will last 12 weeks and consist of exercise training and psychoeducation sessions. During the PR program, patients in the EG will receive a pedometer to self-monitor their PA and individualized step-count goals. They will continue to use the pedometers and receive individualized goals for 3 months after the program.
The impact of the intervention will be explored using a mixed-methods approach.
Assessments will be conducted in both groups at 4 time points: before, immediately after, 3 and 6 months after the PR program. Physical activity levels, lung function, breathlessness, exercise tolerance, peripheral muscle strength, health-related quality of life and healthcare utilization will be assessed in both groups in these time points.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •clinical diagnosis of COPD according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD) criteria
- •≥ 18 years old
- •clinical stability for 1 month prior to the study (no hospital admissions or exacerbations)
- •able to provide their own informed consent
Exclusion Criteria
- •inability to understand and co-operate
- •presence of severe psychiatric conditions
- •presence of severe neurologic/ musculoskeletal conditions and/or unstable cardiovascular disease
- •participation in regular strenuous exercise (e.g., greater than 10 hours per week of running, swimming, weightlifting or any other similar physical activity) prior to the study
Arms & Interventions
Control group
Intervention: Pulmonary rehabilitation (PR) (Behavioral)
Experimental group
Intervention: Pulmonary rehabilitation (PR) plus PA monitoring and feedback from a pedometer (Behavioral)
Outcomes
Primary Outcomes
Change in physical activity levels
Time Frame: 1 week before, 1 week after, 3 and 6 months after the PR program
Physical activity data will be collected using a triaxial accelerometer. Number of steps per day and time spent in sedentary, light and moderate-to-vigorous intensity activities will be assessed. Time spent in different postures (i.e., standing, sitting and lying) will also be determined.
Secondary Outcomes
- Change in behavioral regulations in exercise(1 week before, 1 week after, 3 and 6 months after the PR program)
- Change in activities limitation resulting from breathlessness(1 week before, 1 week after, 3 and 6 months after the PR program)
- Change in general self-efficacy(1 week before, 1 week after, 3 and 6 months after the PR program)
- Change in health-related quality of life(1 week before, 1 week after, 3 and 6 months after the PR program)
- Patients' perspectives about the intervention (experimental group only)(Immediately after the intervention)
- Change in exercise tolerance(1 week before, 1 week after, 3 and 6 months after the PR program)
- Change in peripheral muscle strength(1 week before, 1 week after, 3 and 6 months after the PR program)
Investigators
Alda Sofia Pires de Dias Marques
Senior Lecturer
Aveiro University