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

Osteoarthritis Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06070818
• Other study ID #: HC230506
• Status: Recruiting
• Phase: N/A
• Start date: September 18, 2023
• Est. completion date: July 28, 2024

Study information

• Verified date: September 2023
• Source: The University of New South Wales
• Contact: Claire Burley, PhD
• Phone: +61 (2) 9065 3510
• Email: c.burley[@]unsw.edu.au
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 28, 2024
• Est. primary completion date: June 26, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Decline
• Cognitive Dysfunction
• Osteoarthritis

Intervention

Other:
• Healthy Body & Mind Program
12-week physical activity and lifestyle education program

Locations

Country	Name	City	State
Australia	UNSW Medicine & Health Lifestyle Clinic	Sydney	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
The University of New South Wales

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Chronic pain questionnaire	Western 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).	12 weeks
Other	Depression, anxiety & stress questionnaire	Depression 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.	12 weeks
Other	Physical function: 6-minute walk test	Assesses 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.	12 weeks
Other	Cardiovascular disease (CVD) risk profile questionnaire	ADCVD (https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/). Tool calculated % risk, higher % indicates greater risk for CVD.	12 weeks
Other	Sleep questionnaire	Pittsburgh Sleep Quality Index (PSQI); Score range 0-21; higher scores indicate worse sleep)	12 weeks
Other	Physical function: handgrip strength physical test	Accesses physical strength in kilograms (kg). Average score of 3 attempts on each hand using a dynamometer; higher kg indicates more strength.	12 weeks
Other	Physical function: single leg stance test (balance) physical test	Physical 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.	12 weeks
Primary	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	Cognition questionnaire	Montreal Cognitive Assessment (MoCA); Score range 0-30; higher scores mean better cognition. Measure can also be broken down into subscales.	12 weeks