Cognitive DeclineNCT06070818
Healthy Body & Mind Program for Older Adults Living With Osteoarthritis and Cognitive Decline
A study testing Healthy Body & Mind Program in people with Cognitive Decline and Osteoarthritis, run by The University of New South Wales at 1 site in Australia.
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. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Cognitive Decline, Osteoarthritis
- What is being tested?
- Healthy Body & Mind Program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteAustralia
- Study dates
- 18 Sep 2023to 28 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
UNSW Medicine & Health Lifestyle Clinic
Sydney, New South Wales, 2052
Claire Burley, PhD, +61 (02) 9065 3510, c.burley@unsw.edu.au
About this study
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
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:
Read more
- 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).
- Conditions
- Cognitive Decline, Osteoarthritis
- Being tested
- Healthy Body & Mind Program
- Keywords
- dementia, lifestyle, multidisciplinary, physical activity, nutrition, depression, anxiety, pain, osteoarthritis, cognitive decline
- Medical subject headings
- Cognitive Dysfunction, Osteoarthritis, Dementia, Motor Activity, Depression, Anxiety Disorders, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Healthy Body & Mind ProgramOther
12-week physical activity and lifestyle education program
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | 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. Receives: Other: Healthy Body & Mind Program |
| Wait-list control | No intervention | 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 being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 weeks
Secondary outcomes (1)
Cognition questionnaire
Montreal Cognitive Assessment (MoCA); Score range 0-30; higher scores mean better cognition. Measure can also be broken down into subscales.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2023
- Study start18 Sep 2023
- Primary completion26 Jun 2024 (estimated)
- Study completion28 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cognitive DeclineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomised trial with a wait-list control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The University of New South Wales
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Claire Burley, The University of New South Wales
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06070818
- Sponsor's protocol ID
- HC230506
- Status last verified
- Sep 2023
- First submitted
- 25 Sep 2023
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Burley CV, Yeates W, McLeod KA, Jones MD, Borges N, Brodaty H, Parmenter BJ. Healthy Body and Mind Program to Improve Health Outcomes and Reduce Dementia Risk in People With Osteoarthritis: Protocol for a Feasibility and Acceptability Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Nov 6;14:e75816. doi: 10.2196/75816.
PubMed 41197122
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06070818
- Acronym / sponsor ID
- HC230506
- Conditions
- Cognitive Decline, Osteoarthritis
- Keywords
- dementia, lifestyle, multidisciplinary, physical activity, nutrition, depression, anxiety, pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- The University of New South WalesUniversity, hospital or other
- Study start
- 18 Sep 2023 (actual)
- Primary completion
- 26 Jun 2024 (estimated)
- Study completion
- 28 Jul 2024 (estimated)
- First posted
- 6 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A randomised trial with a wait-list control.
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Healthy Body & Mind ProgramHealthy 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. |
| Wait-list control | No intervention | –Usual care. Participants will not be recruited if they are taking part in another research intervention or receiving treatment other than usual care. |
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Healthy Body & Mind Program12-week physical activity and lifestyle education program | Other | Intervention |
Primary outcome
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.
1 secondary outcome
Cognition questionnaire
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
- Derived from this study: PubMed 41197122Burley CV, Yeates W, McLeod KA, Jones MD, Borges N, Brodaty H, Parmenter BJ. Healthy Body and Mind Program to Improve Health Outcomes and Reduce Dementia Risk in People With Osteoarthritis: Protocol for a Feasibility and Acceptability Pilot Randomized Controlled Trial. JMIR Res Protoc. 2025 Nov 6;14:e75816. doi: 10.2196/75816.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Healthy Body & Mind Program in people with Cognitive Decline and Osteoarthritis, run by The University of New South Wales at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Claire Burley, PhD (+61 (2) 9065 3510, c.burley@unsw.edu.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life questionnaire (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06070818, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2023.