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

Claire V Burley; William Yeates; Kelly A McLeod; Matthew D Jones; Nattai Borges; Henry Brodaty; Belinda J Parmenter

doi:10.2196/75816

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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

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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

Claire V Burley, William Yeates, Kelly A McLeod, Matthew D Jones, Nattai Borges, Henry Brodaty and Belinda J Parmenter

JMIR Research Protocols, Vol.14, pp.1-14

2025

DOI: https://doi.org/10.2196/75816

PMCID: PMC12635591

PMID: 41197122

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Abstract

healthy aging

osteoarthritis

pilot randomized controlled trial

dementia

lifestyle

physical activity

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

Details

Title: 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
Authors: Claire V Burley (Corresponding Author) - Curtin University
William Yeates - Hammond Innovations (Australia)
Kelly A McLeod - UNSW Sydney
Matthew D Jones - Neuroscience Research Australia
Nattai Borges - UNSW Sydney
Henry Brodaty - UNSW Sydney
Belinda J Parmenter - University of the Sunshine Coast, Queensland, School of Health - Sports & Exercise Science
Publication details: JMIR Research Protocols, Vol.14, pp.1-14
Publisher: JMIR Publications, Inc.
Date published: 2025
DOI: 10.2196/75816
ISSN: 1929-0748
PMID: 41197122; PMC12635591
Copyright note: ©Claire V Burley, William Yeates, Kelly A McLeod, Matthew D Jones, Nattai Borges, Henry Brodaty, Belinda J Parmenter. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 06.Nov.2025. This is an open-access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on https://www.researchprotocols.org, as well as this copyright and license information must be included.
Data Availability: The datasets generated or analyzed during this study are available from the corresponding author on reasonable request.
Grant note: This research is supported by philanthropic funding provided by the Faye Patricia Williams Estate.
Organisation Unit: School of Health - Sports & Exercise Science
Language: English
Record Identifier: 991192243602621
Output Type: Journal article

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