Accepted for/Published in: JMIR Research Protocols
Date Submitted: May 11, 2023
Date Accepted: May 25, 2023
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Feasibility of a Home-Based Cognitive-Physical Exercise Program in Chronic Obstructive Pulmonary Disease Patients: Protocol for a Feasibility and Pilot Randomized Controlled Trial
ABSTRACT
Background:
Chronic Obstructive Pulmonary Disease (COPD) is a progressive condition associated with physical and cognitive impairments contributing to difficulty performing activities of daily living (ADL) that require dual tasking (e.g., walking and talking). Despite evidence showing that cognitive decline occurs among COPD patients and may contribute to functional limitations and decreased health-related quality of life (HRQL), pulmonary rehabilitation continues to focus mainly on physical training (i.e., aerobic and strength exercises). An integrated cognitive and physical training program compared to physical training alone may be more effective towards increasing dual-tasking ability among people living with COPD, leading to greater improvements in performance of ADL and HRQL.
Objective:
The aims of this study are: (1) To evaluate the feasibility of an 8-week randomized controlled trial of a home-based, cognitive-physical training (C-PT) versus physical training (PT) for patients with moderate-severe COPD; and (2) To derive preliminary estimates of C-PT intervention efficacy on measures of physical and cognitive function, dual-task performance, ADL, and HRQL.
Methods:
Twenty-four participants with moderate-severe COPD will be recruited and randomized to C-PT or PT. All participants will be prescribed an individualized home physical exercise program comprised of five days of moderate intensity aerobic exercise (30-50 minutes per session) and two days of whole-body strength training per week. The C-PT group will also perform cognitive training for approximately 60 minutes, five days per week via the BrainHQ platform (Posit Science Corporation). Participants will meet once weekly with an exercise professional (via videoconference) who will provide support by reviewing progression of their training and addressing any queries. Feasibility will be assessed through recruitment rate, program adherence, satisfaction, attrition, and safety. Intervention efficacy of dual-task performance, physical function, ADL, and HRQL will be evaluated at baseline, 4 and 8 weeks. Descriptive statistics will be used to summarize intervention feasibility. Paired t-tests and t-tests will be used to compare the changes in the outcome measures over the 8-week study period within and between the 2 randomized groups.
Results:
Enrollment started in January 2022. It is estimated that the enrollment period will be 24 months with data collection to be completed by December 2023.
Conclusions:
A supervised home-based cognitive-physical training program may be an accessible intervention to improve dual-tasking ability in people living with COPD. Evaluating feasibility and effect estimates is a critical first step to inform future clinical trials evaluating this approach and its effects on physical and cognitive function, ADL performance and HRQL. Clinical Trial: ClinicalTrials.gov NCT05140226; https://clinicaltrials.gov/ct2/show/NCT05140226
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