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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06070818
Other study ID # HC230506
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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