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Changing the focus: Facilitating engagement in physical activity for people living with mild dementia in a local community - A feasibility study

Changing the focus: Facilitating engagement in physical activity for people living with mild dementia in a local community - A pre and post mixed methods feasibility study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000983606
Enrollment
7
Registered
2023-09-08
Start date
2024-04-19
Completion date
2025-03-28
Last updated
2025-09-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

"Changing the Focus" program addresses two significant health problems of older Australians: (a) Dementia. The incidence and prevalence of dementia in Australia is projected to grow from 459,000 in 2020, to 1,076,000 by 2058. While the major direct impacts of dementia are cognitive impairment and progressive cognitive decline, onset and progression of dementia are also associated with other health problems that have significant negative personal and carer impact, and add resource and economic cost to health and care systems. Impacts to the individual include reduced independence, physical function, balance, mobility, and community participation, poor mental health, and increased falls. (b) Low levels of physical activity. Older people generally have low physical activity levels, with only 25% of Australians aged >65 years meeting physical activity guidelines. People with dementia have even lower activity levels. Further, physical activity reduction post dementia diagnosis is associated with accelerated cognitive decline. For older people, higher physical activity levels reduce the risk of chronic disease and falls, and improve balance, mobility, function, psychological health, wellbeing and quality of life. Systematic review evidence supports that various forms of physical activity can be implemented safely, and achieve similar outcomes for people with dementia and improve or delay decline in cognition and structural brain changes. Other benefits include improved activities of daily living and reduced social isolation. No systematic approach exists for identifying physical activity needs, or promoting physical activity in people with dementia, despite growing evidence of physical activity benefits along the dementia pathway. This research addresses this major unmet need for an early, systematic approach to identify physical activity needs for people with mild dementia, and embed referral pathways/training opportunities for exercise leaders to support improved physical activity options. Effective management of physical inactivity is required to improve outcomes for the person with dementia and their carer before later stages of dementia, when problems become greater and less amenable to intervention.

Interventions

Preparation: In preparation for the intervention, the project team will develop a training program for exercise practitioners in the Frankston / Mornington Peninsula area, Victoria, Australia who are interested in improving their understanding of strategies to support working with people with mild dementia in programs they provide. Training will include in-person opportunities at the start of the intervention period, and online resources will be made available for exercise practitioners who eng

Preparation: In preparation for the intervention, the project team will develop a training program for exercise practitioners in the Frankston / Mornington Peninsula area, Victoria, Australia who are interested in improving their understanding of strategies to support working with people with mild dementia in programs they provide. Training will include in-person opportunities at the start of the intervention period, and online resources will be made available for exercise practitioners who engage with the program. Another round of in-person training opportunities can be arranged mid study depending on the interest of new exercise practitioners who join the program. We encourage exercise practitioners to attend the training program, however, this training is optional (not compulsory for the intervention). This is because in usual practice, exercise practitioners do not have to attend training to do their daily work. If they choose to do the training, they can decide to attend in person or online or do both. The in-person training workshop can cater for up to 30 practitioners per workshop and will be facilitated by two project team members. The in-person training will be conducted at the commencement of project recruitment and a repeated session may occur approximately 6-9 months after project commencement, depending on the interest from new physical activity providers who engage with the program over time. The in-person training workshop will be a once off session, approximately 2-3 hours in duration with a 15 minutes rest break during the workshop. The online training is expected to take approximately 2-3 hours to complete, consisting of all learning modules and further e-resources, open to those interested throughout the study period. An updated Peninsula Health physical activity program directory in the local areas will be promoted through the training program, and be made available to the research staff supporting the decision making about suitable physical activity options in the local area for each participant with dementia, as well as to referrers and providers who request a copy. The shared decision support tool is being developed based on results from a series of three stakeholder co-design panels and interviews incorporating key stakeholders (including people with dementia and their carers, exercise providers, health services managers, and peak organisation representatives) that had the broad aim of informing approaches to optimise uptake and sustained participation in increased physical activity for people with mild dementia. The shared decision support tool notes assessment items (relating to physical performance measures) and questions that may influence physical activity decisions (including previous and current physical activities, health problems impacting physical activity, transport factors, and costs). It will be an A4 page with prompt questions and progresses the users (the health professional, the person with dementia and their carer) through to the stage of identifying one or more preferred physical activity options to follow up with in the local area. Physical activity options will include structured programs such as gym, group exercise or home programs; informal physical activity programs such as a walking program (individual or as a group), and recreational activities that have a physical activity component (eg lawn bowls, golf, dance). First home visit (~2.5 hours). Following recruitment and screening for eligibility criteria, an initial home visit will be organised by the study therapist (a Physiotherapist or Exercise Physiologist) at the home of the person with dementia and their carer. This first home visit will include (1) a consenting process (see details in the section of Ethics and ethical issues-consent and withdrawal) for the person with dementia +/- carers if applicable, (2) assessment of baseline physical performance outcomes; (3) identification of domains of physical performance (based on assessment outcomes) outside of age adjusted normal limits as potential intervention priorities, (4) discussion of physical activities that are likely to address impairments, (5) discussion about physical activities they enjoy, or have previously undertaken, and (6) discussion of physical activity options available locally. A shared-decision support tool (see above) will be used by the study therapist and the person with dementia (and their carer if they have one) to aid the decision making discussion used by the study therapist and the person with dementia and their carer in this home visit. This discussion will also incorporate the setting of physical activity goals. Whatever physical activity options are selected, each individual’s program will aim to: (1) address identified physical impairments; (2) incorporate multimodal (balance, strength and fitness) physical activities personalised to the person, across the week; and (3) progress dosage of physical activity intervention by 10-20% / month from the baseline physical activity level, starting from month 1 (e.g. if doing 30 min/week, initial target=36 min/week) and aiming to progress at each month to reach a minimum 12-month target of greater than or equal to 150 min/week. Progression principles for increasing dosage will be provided to participants/carers and discussed during motivational support calls during the 12 months intervention period. The total time of physical activity participation undertaken each week for new and/or changed physical activities as a result from participation in the study (frequency and duration) will be recorded in a physical activity diary on a weekly basis by the person with mild dementia or their carer. To assist with the discussion of physical activity options available locally, the Peninsula Health physical activity program directory will be utilised, as well as other programs the research team identify. Examples of local physical activity programs that may be discussed include group exercise (e.g. community health centre), Council on The Ageing strength training programs, gym programs, and walking programs. Individually tailored home exercise programs (provided by the study therapist) will also be offered as another option (it is anticipated this option may be selected by approximately 40%), augmented by telehealth options. Second home visit (~45 mins). The study therapist will perform a second home visit for the person with dementia and/or their carer at week 3 of the decision-making session (when the physical activity plan has commenced) to provide motivational support. Third home visit (~1 hour). The study therapist will perform a third home visit for the person with dementia and/or their carer at six months to repeat physical performance outcomes, and discuss participation level, participation barriers and facilitators, and sustained participation in physical activities longer term. Fourth home visit (~1 hour). The study therapist will perform a fourth (and final) home visit for the person with dementia and/or their carer at 12 months to repeat physical performance outcomes, and discuss participation level, participation barriers and facilitators, and maintenance of physical activity longer term. Motivational support (~20 minutes for each phone/video call). After the first home visit, motivational support will be provided by the study therapist through a series of telephone contacts. Seven phone calls (or video-conference) will occur in the months 0-6 of each individual’s intervention (suggested phone schedule at week 2, 6, 9, 12, 16, 20 and 24). Guided by the COM-B framework for behaviour change, the aim is to increase capability (defined as the individual's psychological and physical capacity to engage in the physical activity program by having the necessary knowledge and skills), provide motivation (defined as processes that energize and direct behaviour including goals and decision-making) and capitalise on the opportunity (defined as all the factors that lie outside the individual that make physical activity participation possible) to reinforce exercise behaviour. Each call will focus on discussing the program, challenges, barriers, facilitators, revisiting the goal and troubleshooting for solutions. If indicated, (e.g. health status change) additional home visits or phone calls may be scheduled.

Sponsors

Monash University
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No

Inclusion criteria

For people with mild dementia or cognitive impairment: Adults (age greater or equal to 60 years); living in the community; medical diagnosis of dementia–mild severity (MMSE greater or equal to 18) or people without a medical diagnosis of dementia and with a MMSE score of 18-23 inclusive, at recruitment; not housebound due to physical impairments (e.g. severe stroke); not meeting World Health Organisation physical activity guidelines for older people (<150 minutes moderate/vigorous physical activity/week); and have capacity to consent and willingness to assist in data collection. For a person with dementia who is unable to provide consent, they can participate in the study if they have an informal carer responsible who will be able to provide consent on their behalf. Presence of an informal carer is preferred but not essential. Where available, they will be an important support for the person with dementia during the intervention. Recruitment will include people from culturally and linguistically diverse backgrounds who have sufficient English proficiency to understand the study, assessment / intervention instructions, or have a readily available interpreter (family member/friend able to assist). Note that a purposive sub-sample of the participants with dementia will be recruited to undertake semi-structured interviews at 6 months, with a separate consent process for this component. For informal carer: Adults (age greater or equal to 18 years); willingness to assist in data collection; capable to assist the person with dementia to adhere to the chosen physical activity program and/or home exercises if required. Note that a purposive sub-sample of informal carers will be recruited to undertake semi-structured interviews at 6 months, with a separate consent process for this component. For referrers and exercise leaders providing physical activity options for participants with dementia: Health professionals (e.g. general practitioners, Cognitive Dementia and Memory Service staff, community therapists) who refer people with dementia to the “Changing the Focus” program, and exercise practitioners who implement physical activity programs with participants will be involved in semi-structured interviews to obtain their perspectives of the program. Note that a purposive sub-sample of referrers and exercise leaders will be selected to participate in semi-structured interviews. The following answers (minimum and maximum age, sex and healthy volunteers) refer to the Key participant group "People with mild dementia/cognitive impairment"

Exclusion criteria

For people with mild dementia/cognitive impairment: Not living in the community of Frankston/Mornington Peninsula region, MMSE cognitive score if without a dementia diagnosis is less than 18 or higher than 23 or MMSE cognitive score of less than 18 for those with a dementia diagnosis, those already meeting 150 minutes of physical activity per week, those who are housebound. For informal carers of people with mild dementia/cognitive impairment: Aged less than 18 years. For referrers: Those who are not health professionals or not working in Frankston/Mornington Peninsula and those who have not referred one or more of their clients to the "Changing the Focus" program For exercise providers: Those who are not working in Frankston/Mornington Peninsula and those who do not provide a physical activity program to one or more of the people with mild dementia participating in the "Changing the Focus" program

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026