Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
Official title:
The Role of Home-monitoring in the Adherence of Patients With Chronic Obstructive Pulmonary Disease to Long-term Rehabilitation
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.
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.
Descriptive statistics will be used to characterize the sample. To analyze changes in
outcome measures, data from the two groups will be compared at each time point.
Patients in the EG will also be invited to attend focus groups after the intervention to
assess their perspective about the intervention and their satisfaction with the use of the
pedometer.
A sample size calculation using the primary outcome was performed based in a previous pilot
study. It was found that 12 patients with COPD would be required in each group to provide
80% power (alpha = 0.05) to detect significant differences between groups. However, as PR
programs usually have considerable dropouts (around 30%), 16 patients with COPD were
recruited for each group.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
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