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

September 30, 2023 updated by: Claire Burley, The University of New South Wales

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

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia, 2052
        • Recruiting
        • UNSW Medicine & Health Lifestyle Clinic
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Other: Healthy Body & Mind Program
12-week physical activity and lifestyle education program
No Intervention: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life questionnaire
Time Frame: 12 weeks
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cognition questionnaire
Time Frame: 12 weeks
Montreal Cognitive Assessment (MoCA); Score range 0-30; higher scores mean better cognition. Measure can also be broken down into subscales.
12 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Chronic pain questionnaire
Time Frame: 12 weeks
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
Depression, anxiety & stress questionnaire
Time Frame: 12 weeks
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
Physical function: 6-minute walk test
Time Frame: 12 weeks
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
Cardiovascular disease (CVD) risk profile questionnaire
Time Frame: 12 weeks
ADCVD (https://tools.acc.org/ascvd-risk-estimator-plus/#!/calculate/estimate/). Tool calculated % risk, higher % indicates greater risk for CVD.
12 weeks
Sleep questionnaire
Time Frame: 12 weeks
Pittsburgh Sleep Quality Index (PSQI); Score range 0-21; higher scores indicate worse sleep)
12 weeks
Physical function: handgrip strength physical test
Time Frame: 12 weeks
Accesses physical strength in kilograms (kg). Average score of 3 attempts on each hand using a dynamometer; higher kg indicates more strength.
12 weeks
Physical function: single leg stance test (balance) physical test
Time Frame: 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of New South Wales

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 18, 2023

Primary Completion (Estimated)

June 26, 2024

Study Completion (Estimated)

July 28, 2024

Study Registration Dates

First Submitted

September 25, 2023

First Submitted That Met QC Criteria

September 30, 2023

First Posted (Actual)

October 6, 2023

Study Record Updates

Last Update Posted (Actual)

October 6, 2023

Last Update Submitted That Met QC Criteria

September 30, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HC230506

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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