Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 11, 2025
Date Accepted: Sep 30, 2025
Warning: This is an author submission that is not peer-reviewed or edited.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 and acceptability of an evidence-based, pilot randomised controlled trial to improve health outcomes and reduce dementia risk in people with osteoarthritis. Study protocol for the Healthy Body & Mind Program (HBMP)
ABSTRACT
Introduction: Fifty-five million people worldwide are living with dementia. Osteoarthritis (OA) occurs in half of older adults and is associated with pain, depression and increased dementia risk. Currently, no program exists for people living with OA and cognitive decline that addresses modifiable risk factors such as physical inactivity and lifestyle behaviours. This study will examine feasibility, acceptability and health outcomes following a 12-week Healthy Body & Mind Program designed for people with OA and cognitive decline. Findings will inform designs for larger trials.
Methods:
Twenty consenting participants aged 45 years and over, with OA and cognitive decline will be randomly allocated to the 12-week program or a wait-list control group. The trial is registered at clinicaltrials.gov, registration number: NCT06070818 (6th October 2023). Feasibility and acceptability will be assessed by retention and adherence rates to the program, the number of people who 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, memory), pain, psychological health (stress, anxiety and depression) and physical health. Ethics and dissemination: This study has been reviewed and approved by the University of New South Wales Human Research Ethics Committee (HREC: HC230506). This project will be carried out according to the National Statement on Ethical Conduct in Human Research (2007). The study’s findings will be published in peer- reviewed journals and disseminated at national and international conferences and through social media. Participant confidentiality will be maintained in line with ethical procedures. Conclusion: This protocol reports methods to determine feasibility, acceptability and preliminary health outcome data of a Healthy Body & Mind Program informed by consumers with lived experience of dementia and OA.
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