Healthy Body & Mind Program for Older Adults Living With Osteoarthritis and Cognitive Decline

Study Overview
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Brief Summary
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The goal of this pilot randomised clinical trial is to compare a 12-week Healthy Body & Mind Program to usual care in older adults living with cognitive decline and osteoarthritis. The main questions it aims to answer are: Does the Healthy Body & Mind Program improve health-related quality of life in older adults living with cognitive decline and osteoarthritis (pre/post and intervention/control)? Does the Healthy Body & Mind Program improve other health outcomes (cognition, pain, anxiety/depression, physical function) in older adults living with cognitive decline and osteoarthritis (pre/post and intervention/control)? Participants will complete a co-designed and multidisciplinary 12-week program that includes physical activity and lifestyle education (nutrition, social activity and managing anxiety/depression). Researchers will compare outcomes between the intervention group and a wait-list control to see if there are difference in outcome measures (quality of life, cognition, pain, anxiety/depression, physical function).

Official Title
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Healthy Body & Mind Program: A Pilot Randomised Controlled Trial to Improve Quality of Life, Reduce Pain, and Reduce Dementia Risk in People Living With Cognitive Decline and Osteoarthritis

Conditions
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Cognitive Decline, Osteoarthritis

Intervention / Treatment
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* Other: Healthy Body & Mind Program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults aged 55 or above. Montreal Cognitive Assessment score 18-25 indicating mild cognitive decline or mild dementia. Diagnosed with osteoarthritis. Able to safely undertake study assessments and complete exercise without assistance. Exclusion Criteria: Montreal Cognitive Assessment score below 18. Display an abnormal cardiovascular response to exercise (as seen during the baseline exercise test) and your doctor does not provide medical clearance to exercise. Are unable to speak English and do not have a translator. Have orthopedic or neuromuscular limitations that prevent you from performing the exercise. Are deemed unsuitable for group exercise sessions following initial assessment by an Accredited Exercise Physiologist within the UNSW Lifestyle Clinic.

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: A randomised trial with a wait-list control.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention<br>Healthy Body & Mind Program: In summary, the program includes two visits to the University of New South Wales (UNSW) Medicine & Health Lifestyle Clinic at the beginning and end of the program for Initial and Final Assessments, and two weekly sessions for 12 weeks (24 sessions in total) to the UNSW Medicine & Health Lifestyle Clinic to complete the Healthy Body & Mind Program. Participants will also be invited to take part in a focus group either at the clinic or online (via Teams/ zoom) at the end of the program. | Other: Healthy Body & Mind Program<br>* 12-week physical activity and lifestyle education program<br>|
| No Intervention: Wait-list control<br>Usual care. Participants will not be recruited if they are taking part in another research intervention or receiving treatment other than usual care. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life questionnaire | EuroQoL health-related quality of life (EQ-5D; https://euroqol.org/); Score range 0-1; 1 indicating full health, 0 indicating bad health. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognition questionnaire | Montreal Cognitive Assessment (MoCA); Score range 0-30; higher scores mean better cognition. Measure can also be broken down into subscales. | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anxiety, dementia, lifestyle, multidisciplinary, physical activity, nutrition, depression, pain, osteoarthritis, cognitive decline