Feasibility of a Home-Based Cognitive-Physical Exercise Program in Patients With Chronic Obstructive Pulmonary Disease: Protocol for a Feasibility and Pilot Randomized Controlled Trial

Dmitry Rozenberg; Josh Shore; Encarna Camacho Perez; Sahar Nourouzpour; Megha Ibrahim Masthan; Daniel Santa Mina; Jennifer L Campos; Ella Huszti; Robin Green; Mohammad Hashim Khan; Ambrose Lau; David Gold; Matthew B Stanbrook; W Darlene Reid

doi:10.2196/48666

Feasibility of a Home-Based Cognitive-Physical Exercise Program in Patients With Chronic Obstructive Pulmonary Disease: Protocol for a Feasibility and Pilot Randomized Controlled Trial

JMIR Res Protoc. 2023 Jul 12:12:e48666. doi: 10.2196/48666.

Authors

Dmitry Rozenberg^{1

2}, Josh Shore³, Encarna Camacho Perez³, Sahar Nourouzpour³, Megha Ibrahim Masthan³, Daniel Santa Mina^{4

5}, Jennifer L Campos^{6

7}, Ella Huszti⁸, Robin Green⁶, Mohammad Hashim Khan³, Ambrose Lau^{2

3}, David Gold⁹, Matthew B Stanbrook^{2

3}, W Darlene Reid^{6

10

11}

Affiliations

¹ Respirology and Lung Transplantation, Toronto General Hospital Research Institute, University Health Network, Toronto, ON, Canada.
² Temerty Faculty of Medicine, University of Toronto, Toronto, ON, Canada.
³ Division of Respirology, University Health Network, Toronto, ON, Canada.
⁴ Faculty of Kinesiology and Physical Education, University of Toronto, Toronto, ON, Canada.
⁵ Department of Anesthesia and Pain Management, University Health Network, Toronto, ON, Canada.
⁶ Toronto Rehabilitation Institute (KITE), University Health Network, Toronto, ON, Canada.
⁷ Department of Psychology, University of Toronto, Toronto, ON, Canada.
⁸ Biostatistics Research Unit, University Health Network, Toronto, ON, Canada.
⁹ Krembil Neuroscience Centre, Toronto Western Hospital, University Health Network, Toronto, ON, Canada.
¹⁰ Department of Physical Therapy, University of Toronto, Toronto, ON, Canada.
¹¹ Interdivisional Department of Critical Care Medicine, University of Toronto, Toronto, ON, Canada.

PMID: 37436794
PMCID: PMC10372770
DOI: 10.2196/48666

Abstract

Background: Chronic obstructive pulmonary disease (COPD) is a progressive condition associated with physical and cognitive impairments contributing to difficulty in performing activities of daily living (ADLs) that require dual tasking (eg, walking and talking). Despite evidence showing that cognitive decline occurs among patients with COPD and may contribute to functional limitations and decreased health-related quality of life (HRQL), pulmonary rehabilitation continues to focus mainly on physical training (ie, aerobic and strength exercises). An integrated cognitive and physical training program compared to physical training alone may be more effective in increasing dual-tasking ability among people living with COPD, leading to greater improvements in performance of ADLs and HRQL.

Objective: The aims of this study are to evaluate the feasibility of an 8-week randomized controlled trial of home-based, cognitive-physical training versus physical training for patients with moderate to severe COPD and derive preliminary estimates of cognitive-physical training intervention efficacy on measures of physical and cognitive function, dual task performance, ADLs, and HRQL.

Methods: A total of 24 participants with moderate to severe COPD will be recruited and randomized into cognitive-physical training or physical training. All participants will be prescribed an individualized home physical exercise program comprising 5 days of moderate-intensity aerobic exercise (30-50 minutes/session) and 2 days of whole-body strength training per week. The cognitive-physical training group will also perform cognitive training for approximately 60 minutes, 5 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 the progression of their training and addressing any queries. Feasibility will be assessed through the recruitment rate, program adherence, satisfaction, attrition, and safety. The intervention efficacy regarding dual task performance, physical function, ADLs, and HRQL will be evaluated at baseline and at 4 and 8 weeks. Descriptive statistics will be used to summarize intervention feasibility. Paired 2-tailed t tests and 2-tailed 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, respectively.

Results: Enrollment started in January 2022. It is estimated that the enrollment period will be 24 months long, 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 the 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.

Trial registration: ClinicalTrials.gov NCT05140226; https://clinicaltrials.gov/ct2/show/NCT05140226.

International registered report identifier (irrid): DERR1-10.2196/48666.

Keywords: chronic obstructive; cognitive training; physical exercise; pilot study; pulmonary disease; randomized controlled trial; telerehabilitation.

©Dmitry Rozenberg, Josh Shore, Encarna Camacho Perez, Sahar Nourouzpour, Megha Ibrahim Masthan, Daniel Santa Mina, Jennifer L Campos, Ella Huszti, Robin Green, Mohammad Hashim Khan, Ambrose Lau, David Gold, Matthew B Stanbrook, W Darlene Reid. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 12.07.2023.

Associated data

ClinicalTrials.gov/NCT05140226