Healthy Body and Mind Program to Improve Health Outcomes and Reduce Dementia Risk in People With Osteoarthritis: Protocol for a Feasibility and Acceptability Pilot Randomized Controlled Trial

JMIR Res Protoc. 2025 Nov 6;14:e75816. doi: 10.2196/75816.

ABSTRACT

BACKGROUND: Globally, approximately 55 million people are living with dementia. Osteoarthritis occurs in half of all older adults and is associated with pain, depression, and increased dementia risk. Currently, no program exists for people with osteoarthritis and cognitive decline that addresses modifiable risk factors, such as physical inactivity and lifestyle behaviors.

OBJECTIVE: This study aims to examine the feasibility, acceptability, and health outcomes following the 12-week Healthy Body and Mind Program, designed for people with osteoarthritis who are experiencing cognitive decline. The findings will inform the designs of larger trials.

METHODS: In total, 20 consenting participants aged 45 years or older with osteoarthritis and cognitive decline will be randomly allocated to the 12-week program or a waitlist control group. Feasibility and acceptability will be assessed based on retention and adherence rates to the program, the number of people who provide consent to take part in the study, and evaluation questions following completion of the program. Health outcomes will include quality of life, cognition (global, attention, learning, and memory), pain, psychological health (stress, anxiety, and depression), and physical health.

RESULTS: This study has been reviewed and approved by the University of New South Wales Human Research Ethics Committee (HC230506). This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). As of October 2025, we have enrolled 18 participants and completed their data collection. Results are expected to be published in peer-reviewed journals during the first quarter of 2026. Participant confidentiality will be maintained in line with ethical considerations.

CONCLUSIONS: This protocol reports methods to determine feasibility, acceptability, and preliminary health outcome data of the Healthy Body and Mind Program informed by individuals with lived experience of dementia and osteoarthritis.

TRIAL REGISTRATION: ClinicalTrials.gov NCT06070818; clinicaltrials.gov/study/NCT06070818.

INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/75816.

PMID:41197122 | DOI:10.2196/75816