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

Not Applicable

Recruiting

• Conditions: Cognitive Decline; Osteoarthritis

• 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

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