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

NCT06070818 | Unknown DMC

• 1 other identifier: HC230506
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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).

Conditions

Cognitive Decline; Osteoarthritis

Keywords

dementia; lifestyle; multidisciplinary; physical activity; nutrition; depression; anxiety; pain; osteoarthritis; cognitive decline

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Cognition questionnaire

  12 weeks

Other Outcomes (7)

• Chronic pain questionnaire

  12 weeks

• Depression, anxiety & stress questionnaire

  12 weeks

• Physical function: 6-minute walk test

  12 weeks

Study Arms (2)

Intervention

EXPERIMENTAL

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

Wait-list control

NO INTERVENTION

Usual care. Participants will not be recruited if they are taking part in another research intervention or receiving treatment other than usual care.

Interventions

Healthy Body & Mind Program OTHER

12-week physical activity and lifestyle education program

Intervention

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• The University of New South Wales: lead

Study Sites (1)

UNSW Medicine & Health Lifestyle Clinic

Sydney, New South Wales, 2052, Australia

RECRUITING

Related Publications (1)

• Burley CV, Yeates W, McLeod KA, Jones MD, Borges N, Brodaty H, Parmenter BJ. 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. JMIR Res Protoc. 2025 Nov 6;14:e75816. doi: 10.2196/75816.

  PMID: 41197122 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Osteoarthritis; Dementia; Motor Activity; Depression; Anxiety Disorders; Pain

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Behavior; Behavioral Symptoms; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Claire Burley, PhD

CONTACT

+61 (2) 9065 3510; c.burley@unsw.edu.au

Belinda Parmenter, PhD

CONTACT

+61 (2) 9065 7411; b.parmenter@unsw.edu.au

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher collecting the outcome measures will not know whether the person is in the intervention or control group.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator Dr Claire Burley

Model Details: A randomised trial with a wait-list control.

Study Record Dates

• First Submitted: September 25, 2023
• First Posted: October 6, 2023
• Study Start: September 18, 2023
• Primary Completion: June 26, 2024
• Study Completion: July 28, 2024
• Last Updated: October 6, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)