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

Not Applicable

Recruiting

• Conditions: Cognitive Decline; Osteoarthritis
• Interventions: Other: Healthy Body & Mind Program

• Registration Number: NCT06070818
• Lead Sponsor: The University of New South Wales

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-09
• Study Start: 2023-09-18
• Study First Submitted: 2023-09-25
• Study First Submitted QC: 2023-09-30
• Last Update Submitted: 2023-09-30
• Study First Posted: 2023-10-06
• Last Update Posted: 2023-10-06
• Primary Completion: 2024-06-26
• Study Completion: 2024-07-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Intervention	Healthy Body & Mind Program	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

UNSW Medicine & Health Lifestyle Clinic; 🇦🇺 Sydney, New South Wales, Australia