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

NCT ID: NCT06070818

Last Updated: 2023-10-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-18

Study Completion Date

2024-07-28

Brief Summary

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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).

Detailed Description

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Conditions

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Cognitive Decline Osteoarthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

A randomised trial with a wait-list control.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
The researcher collecting the outcome measures will not know whether the person is in the intervention or control group.

Study Groups

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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.

Group Type EXPERIMENTAL

Healthy Body & Mind Program

Intervention Type OTHER

12-week physical activity and lifestyle education program

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Healthy Body & Mind Program

12-week physical activity and lifestyle education program

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The University of New South Wales

OTHER

Sponsor Role lead

Responsible Party

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Claire Burley

Principal Investigator Dr Claire Burley

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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UNSW Medicine & Health Lifestyle Clinic

Sydney, New South Wales, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Claire Burley, PhD

Role: CONTACT

+61 (2) 9065 3510

Belinda Parmenter, PhD

Role: CONTACT

+61 (2) 9065 7411

Facility Contacts

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Claire Burley, PhD

Role: primary

+61 (02) 9065 3510

Other Identifiers

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HC230506

Identifier Type: -

Identifier Source: org_study_id

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