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Can a tailored exercise and home hazard reduction program reduce the rate of falls in community dwelling older people with cognitive impairment or dementia? A Randomised control Trial.

Can a tailored exercise and home hazard reduction program reduce the rate of falls in community dwelling older people with cognitive impairment or dementia? A Randomised control Trial.

Status
Terminated
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12614000603617
Acronym
i-FOCIS
Enrollment
310
Registered
2014-06-06
Start date
2014-06-24
Completion date
2017-07-25
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

There is currently no evidence indicating that it is possible to prevent falls in community dwelling older people with dementia despite this group having a disproportionately higher rate of falls and fractures and poorer outcomes post event. However, there is evidence that a dementia specific approach to care, in which interventions are based on the individuals’ preserved abilities and in which the caregiver is provided with the skills to work effectively with the person with dementia, can be effective in improving daily function for the person with dementia and sense of competence for the carer. The purpose is to investigate whether a home-based exercise program and home hazard reduction program can: 1) reduce the risk of falls in older people with cognitive impairment or dementia, and 2) improve the quality of life of the person with cognitive impairment or dementia and their carer(s).

Interventions

The intervention will consist of a 12 month home-based, individualised exercise and home hazard reduction program. There will be a combined total of 11 visits from the occupational therapist and physiotherapist, with the ratio of visits determined by the identified needs of participants. We anticipate the first 4 visits will occur on a weekly basis (Weeks 1-4) then the next 2 visits will occur (Weeks 7 and 9) to establish the intervention program. Following that the intervention visits will take

The intervention will consist of a 12 month home-based, individualised exercise and home hazard reduction program. There will be a combined total of 11 visits from the occupational therapist and physiotherapist, with the ratio of visits determined by the identified needs of participants. We anticipate the first 4 visits will occur on a weekly basis (Weeks 1-4) then the next 2 visits will occur (Weeks 7 and 9) to establish the intervention program. Following that the intervention visits will take place at the following intervals (Weeks 13, 17, 22, 36 and 48). This will be supplemented by regular phone calls in between visits to the participant / carer to encourage continued engagement and identify any problems with either the exercise or environmental recommendations. We anticipate phone calls to occur on weeks (6, 11, 15, 19, 24, 27, 30, 33, 40 and 44). Both the physio and OT will follow up recommendations made and upgrade programs as this is an important part of the intervention. All participants in the intervention group will undergo the Allen's Cognitive Assessment. The Allen’s model of functional cognition will be used to guide the therapists in tailoring the interventions to the skills and abilities of the participants. The functional cognition results of participants will be discussed with their carers to enhance their knowledge about optimal ways of communicating with the participant and skills with regard to assisting implement the intervention. This important aspect will facilitate active participation of carers without increasing carer burden. A home exercise program based on the Weight-bearing Exercise for Better Balance program will be established. The exercises will be individually prescribed by experienced physiotherapists and will target postural control (balance) and lower limb muscle strength. The participants will be asked to continue to exercises for the 12-month study period. The frequency and duration will be individually prescribed and will be up to 30 minutes 3-6 times a week. It is anticipated that the majority of the intervention group will be offered this intervention and tailored to the needs of the individual based on the results of the baseline physical and functional cognition assessments and in discussion with the participant and their carer. Participants will be provided with a folder outlining the exercises recommended. The format of the exercises will be adjusted to accommodate the cognitive abilities of the participant, with instructions adapted accordingly, i.e. written information, written and pictorial information etc. and the exercises will be progressed under instruction from the physiotherapist over the intervention period. The occupational therapist will undertake a detailed home safety assessment using the Westmead Home Safety Assessment and will provide advice and recommendations to optimise safety within the home. Recommendations following the assessment will be prioritised according to functional cognition of the participant, level of perceived risk and in negotiation with both the participant and carer. Typical recommendations will include removing/ securing loose mats, highlighting step edges with fluorescent tape, sensor lighting to illuminate walkways and bathrooms at night. Grab rails are commonly recommended and individuals will be referred to local home modifications services. Any recommendation for equipment will be done through the local hospital Equipment Lending Pool. The carer education session is conducted by the occupational therapist (OT) in participants’ homes and provides support and education to carers. Some participants with dementia are present during the session, while other sessions are conducted with the carer only. These visits can also be conducted at the research office. These arrangements are determined by the carer prior to the session. The session is informed by the functional cognition assessment and the falls behavioural risk factor assessment of the participant, and the Task Management Strategy Index (TMSI) completed by carers (which identifies strategies carers already use). This information is used to provide tailored strategies to help the carer engage with the exercise program. These include understanding participant cognitive abilities and implications for functional skills and behaviour in positive terms, as well as effective teaching and supervision skills according to the specific cognitive abilities of the participant. While these strategies are targeted to enhancing engagement with the program, they can often be generalised to other situations in everyday life. This visit is flexible in terms of timing within the program – it is usually the fourth OT visit, and occurs after the third or fourth physiotherapy visit (week 17). Depending on the needs of the participants. The carer visit is always within the first six months of the protocol. It usually has a duration of one hour. In addition the intervention group will be required to fill out monthly falls calendars for 12 months and have a baseline, 6 month and 12 month re-assessment.

Sponsors

Professor Jacqueline Close
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)

Eligibility

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

Inclusion criteria

* Sex: Males & Females * 65 + years * Living in the community * MMSE<24 or ACE-R <83 or specialist clinical diagnosis of cognitive impairment or dementia * Must have an identifiable and consenting person responsible and a carer (likely to be the person responsible in many cases) who have a minimum of 3.5 hrs hours of face to face contact with the participant each week for the purposes of reporting of falls and supervising the exercise intervention (3 times per week). * Willingness of participant and carer to give informed consent and to participate in and comply with the study protocol. Proxy consent and participant assent will be used where participants cannot give informed consent.

Exclusion criteria

* Participants with a MMSE < 12/30, as it is considered unlikely such people will be able to engage with the intervention * Participants with the following medical conditions: delirium, acute medical illnesses, severe psychiatric disorders, progressive neurological diseases other than dementia and blindness * Residents of residential aged care facilities * Non-english speaking and no readily available interpreter * People in existing dependent or unequal relationships * People who are highly dependent on medical care * People who may be involved in illegal activity

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 19, 2026