Clinical trial NCT06070818: Healthy Body & Mind Program for Older Adults Living With Osteoarthritis and Cognitive Decline
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Decline
Osteoarthritis
Keywords: dementia
lifestyle
multidisciplinary
physical activity
nutrition
depression
anxiety
pain
osteoarthritis
cognitive decline
Lead sponsor: The University of New South Wales
Sponsor class: OTHER
First posted: 2023-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 55
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: A randomised trial with a wait-list control.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Health-related quality of life questionnaire
timeFrame: 12 weeks
Secondary outcomes:
measure: Cognition questionnaire
timeFrame: 12 weeks
Other outcomes:
measure: Chronic pain questionnaire
timeFrame: 12 weeks
measure: Depression, anxiety & stress questionnaire
timeFrame: 12 weeks
measure: Physical function: 6-minute walk test
timeFrame: 12 weeks
measure: Cardiovascular disease (CVD) risk profile questionnaire
timeFrame: 12 weeks
measure: Sleep questionnaire
timeFrame: 12 weeks
measure: Physical function: handgrip strength physical test
timeFrame: 12 weeks
measure: Physical function: single leg stance test (balance) physical test
timeFrame: 12 weeks
Locations:
city: Sydney
country: Australia
facility: UNSW Medicine & Health Lifestyle Clinic
state: New South Wales
Study officials:
References: