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

Primary Purpose

Cognitive Decline, Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Healthy Body & Mind Program
Sponsored by
The University of New South Wales
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cognitive Decline focused on measuring dementia, lifestyle, multidisciplinary, physical activity, nutrition, depression, anxiety, pain, osteoarthritis, cognitive decline

Eligibility Criteria

55 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • UNSW Medicine & Health Lifestyle ClinicRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Wait-list control

Arm Description

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.

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 Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
September 25, 2023
Last Updated
September 30, 2023
Sponsor
The University of New South Wales
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1. Study Identification

Unique Protocol Identification Number
NCT06070818
Brief Title
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

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
September 18, 2023 (Actual)
Primary Completion Date
June 26, 2024 (Anticipated)
Study Completion Date
July 28, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The University of New South Wales

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline, Osteoarthritis
Keywords
dementia, lifestyle, multidisciplinary, physical activity, nutrition, depression, anxiety, pain, osteoarthritis, cognitive decline

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
A randomised trial with a wait-list control.
Masking
Outcomes Assessor
Masking Description
The researcher collecting the outcome measures will not know whether the person is in the intervention or control group.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait-list control
Arm Type
No Intervention
Arm Description
Usual care. Participants will not be recruited if they are taking part in another research intervention or receiving treatment other than usual care.
Intervention Type
Other
Intervention Name(s)
Healthy Body & Mind Program
Intervention Description
12-week physical activity and lifestyle education program
Primary Outcome Measure Information:
Title
Health-related quality of life questionnaire
Description
EuroQoL health-related quality of life (EQ-5D; https://euroqol.org/); Score range 0-1; 1 indicating full health, 0 indicating bad health.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Cognition questionnaire
Description
Montreal Cognitive Assessment (MoCA); Score range 0-30; higher scores mean better cognition. Measure can also be broken down into subscales.
Time Frame
12 weeks
Other Pre-specified Outcome Measures:
Title
Chronic pain questionnaire
Description
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).
Time Frame
12 weeks
Title
Depression, anxiety & stress questionnaire
Description
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.
Time Frame
12 weeks
Title
Physical function: 6-minute walk test
Description
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.
Time Frame
12 weeks
Title
Cardiovascular disease (CVD) risk profile questionnaire
Description
ADCVD (https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/). Tool calculated % risk, higher % indicates greater risk for CVD.
Time Frame
12 weeks
Title
Sleep questionnaire
Description
Pittsburgh Sleep Quality Index (PSQI); Score range 0-21; higher scores indicate worse sleep)
Time Frame
12 weeks
Title
Physical function: handgrip strength physical test
Description
Accesses physical strength in kilograms (kg). Average score of 3 attempts on each hand using a dynamometer; higher kg indicates more strength.
Time Frame
12 weeks
Title
Physical function: single leg stance test (balance) physical test
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Claire Burley, PhD
Phone
+61 (2) 9065 3510
Email
c.burley@unsw.edu.au
First Name & Middle Initial & Last Name or Official Title & Degree
Belinda Parmenter, PhD
Phone
+61 (2) 9065 7411
Email
b.parmenter@unsw.edu.au
Facility Information:
Facility Name
UNSW Medicine & Health Lifestyle Clinic
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2052
Country
Australia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Claire Burley, PhD
Phone
+61 (02) 9065 3510
Email
c.burley@unsw.edu.au

12. IPD Sharing Statement

Plan to Share IPD
No

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

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