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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06070818
Enrollment
20
Registered
2023-10-06
Start date
2023-09-18
Completion date
2024-07-28
Last updated
2023-10-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Decline, Osteoarthritis

Keywords

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

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).

Interventions

OTHERHealthy Body & Mind Program

12-week physical activity and lifestyle education program

Sponsors

The University of New South Wales
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

The researcher collecting the outcome measures will not know whether the person is in the intervention or control group.

Intervention model description

A randomised trial with a wait-list control.

Eligibility

Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Health-related quality of life questionnaire12 weeksEuroQoL health-related quality of life (EQ-5D; https://euroqol.org/); Score range 0-1; 1 indicating full health, 0 indicating bad health.

Secondary

MeasureTime frameDescription
Cognition questionnaire12 weeksMontreal Cognitive Assessment (MoCA); Score range 0-30; higher scores mean better cognition. Measure can also be broken down into subscales.

Other

MeasureTime frameDescription
Physical function: 6-minute walk test12 weeksAssesses distance in metres walked over 6 minutes as a sub-maximal test of aerobic capacity/endurance. Higher number of metres walked means better physical function and aerobic capacity.
Cardiovascular disease (CVD) risk profile questionnaire12 weeksADCVD (https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/). Tool calculated % risk, higher % indicates greater risk for CVD.
Chronic pain questionnaire12 weeksWestern Ontario and McMaster Universities Arthritis Index (WOMAC); Score range 0-96; 0 represents best health, higher scores indicate more pain. Measure can also be broken down into subscales (e.g., pain and function).
Physical function: handgrip strength physical test12 weeksAccesses physical strength in kilograms (kg). Average score of 3 attempts on each hand using a dynamometer; higher kg indicates more strength.
Physical function: single leg stance test (balance) physical test12 weeksPhysical test used to assess static postural and balance control. The participant must stand unassisted on one leg and is timed in seconds from the time one foot is flexed off the floor to the time when it touches the ground or the standing leg or an arm leaves the hips. Higher number of seconds indicates better balance.
Sleep questionnaire12 weeksPittsburgh Sleep Quality Index (PSQI); Score range 0-21; higher scores indicate worse sleep)
Depression, anxiety & stress questionnaire12 weeksDepression Anxiety Stress Scales (DASS-21); Score range 0-21; higher scores mean worse psychological health. Measure can also be broken down into subscales: depression, anxiety & stress.

Countries

Australia

Contacts

Primary ContactClaire Burley, PhD
c.burley@unsw.edu.au+61 (2) 9065 3510
Backup ContactBelinda Parmenter, PhD
b.parmenter@unsw.edu.au+61 (2) 9065 7411

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026