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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Health-related quality of life questionnaire
Study Overview
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).
Study Design
- Study Type
- Interventional
- 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.
Eligibility Criteria
- Ages
- 55 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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
- •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.
Arms & Interventions
Intervention
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.
Intervention: Healthy Body & Mind Program (Other)
Wait-list control
Usual care. Participants will not be recruited if they are taking part in another research intervention or receiving treatment other than usual care.
Outcomes
Primary Outcomes
Health-related quality of life questionnaire
Time Frame: 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 Outcomes
- Cognition questionnaire(12 weeks)
Investigators
Claire Burley
Principal Investigator Dr Claire Burley
The University of New South Wales