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Falls After Stroke Trial (FAST)

Home-based, tailored intervention to reduce falls after stroke trial.

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12619001114134
Acronym
The FAST study
Enrollment
370
Registered
2019-08-12
Start date
2019-08-21
Completion date
2023-12-15
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

Stroke survivors fall often with fall rates of more than twice that of the general older population, placing an enormous economic burden on the national health system and society in general. The aim of Falls After Stroke Trial (FAST) is to test the effect of home-based, tailored intervention to reduce falls. A sample of community-dwelling stroke (n=370) survivors who have completed formal rehabilitation will be randomly assigned to an experimental group (habit-forming exercise and safety training), or a control group (usual care). The primary outcome measures will be falls recorded daily by the participants and monitored monthly by a researcher blinded to group allocation. Secondary outcomes will be community participation, balance, self-efficacy, mobility, physical activity, health-related quality of life healthcare utilisation and costs.

Interventions

The falls after stroke trial (FAST) will be undertaken in metropolitan Sydney and Canberra Australia. The intervention will have an active 6 month intervention period and a passive (further) 6 months follow-up period. Participants randomised into the intervention (experimental) group will receive a home-based, tailored intervention consisting of habit-forming exercise and home/community safety training depending on their level of disability. For example, the faster walkers (> 0.8 m/s) will have

The falls after stroke trial (FAST) will be undertaken in metropolitan Sydney and Canberra Australia. The intervention will have an active 6 month intervention period and a passive (further) 6 months follow-up period. Participants randomised into the intervention (experimental) group will receive a home-based, tailored intervention consisting of habit-forming exercise and home/community safety training depending on their level of disability. For example, the faster walkers (> 0.8 m/s) will have most emphasis on habit-forming exercise, the slower walkers (< 0.4 m/s) will have most emphasis on safety training, while the middle group (0.4-0.8 m/s) will have a combination of both habit-forming exercise and safety training. Habit-forming exercise will be based on the successful Lifestyle integrated Functional Exercise program which has been shown to be beneficial for older persons with a history of two or more falls or an injurious fall in a study by Professor Lindy Clemson and colleagues [Clemson, L., et al., Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): randomised parallel trial. British Medical Journal, 2012: p. 345]. This program encourages participants to look for ways of doing more physical activity. Activities which challenge their balance and strength will be incorporated into specific daily tasks. They will be performed intentionally and consciously until they become habitual and embedded in daily occupation. Feedback and monitoring via paper documentation and positive reinforcement will be used to enhance the performance of these activities and the self-efficacy of the participants. Rather than a prescribed set of exercises conducted several times a week, activities will occur whenever the opportunity arises during the day. An activity incorporating the strategy of challenging balance by “reducing base of support” might involve a tandem stand while working at the kitchen bench, and over time could be progressed to working while standing on one leg. An activity incorporating the strategy of increasing strength by “bending the knees” might involve squatting instead of bending at the waist to close a drawer, and could be progressed to squatting to close a lower drawer. The safety intervention will focus on environmental adaptations to reduce fall hazards and protective behaviours to reduce risk. The Westmead Home Safety Assessment and the Falls Behavioural Scale for Older People will be used to identify environmental hazards, as well as risks, so that the participants and therapist can generate solutions. A community mobility goal will be identified for each intervention participant that is relevant for them with a plan to practice related strategies . The intervention will incorporate strategies for enhancing self-efficacy, cueing and monitoring to booster adherence, and engagement of participant in planning, decision making and follow through. Participants will have access to a selection of simple home adaptations, such as non-slip strips, double sided tape to secure carpets, LED sensor globes to improve night lighting, in addition to referral to usual home modification services in the community. Participants under the guidance of therapists will be also encouraged to practice safe activities that are within their current capabilities in the home and community. Materials, instruction booklets or any other equipment the participant may need to complete the intervention component will be provided to the participant at no cost. The home-based tailored intervention will be delivered through 7 weekly home visits followed by three booster sessions at Weeks 9, 13, 19 with two phone calls during Week 15 and 23. The intervention dose is warranted, given stroke survivors are at greater risk of falls and we are providing a combined intervention of habit forming exercise and safety. Participants will record practice using weekly logs to monitor adherence to the exercise. It is expected that home visits will take approx. 1-1.5 hours while booster phone calls will last between 30min-1h. The intervention and all assessments will be provided by experienced physiotherapists and occupational therapists. All study parts (assessment, intervention and follow-up) will take place in the comfort of the participant’s home at a mutually convenient time. Therapists have experience in working with older adults, adults with age-related disability and have previously worked in the community or out-patient setting. All assessors will undergo a 2 day training workshop, where they will learn the standardised assessments, data management and any other study related standardised operating procedures. All interventionists (occupational therapists and physiotherapists) will part-take in a 2 day workshop to learn the Life-style integrated physical activity programme as well as learning the home-safety and community mobility programme. Further, occupational therapists must, and physiotherapists are encouraged to complete the online learning module available for home-safety for this cohort. Therapists are required to complete the training successfully prior delivering the intervention. Throughout the intervention trial, various fidelity checks will occur for both assessors and interventionist to ensure standardised procedures. Adherence to the trial will be measured in several ways. Participants are required to document their planned activities in their activity planner while also in reporting, in a pre-defined interval, which activities they have completed via their activity counter. Further, participants will complete the Exercise Adherence Rating Scale (EARS) during their last home visit in week 23 and again during the 12 month follow-up. This will provide us with an objective adherence measure alongside regular documentation.

Sponsors

The University of Sydney
Lead SponsorUniversity

Study design

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

Eligibility

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

Inclusion criteria

People with stroke will be screened and invited to participate if they i) are within 5 years of their first stroke; ii) have been discharged from formal rehabilitation and are community-dwelling; iii) can walk, defined as ‘being able to walk 10 m across flat ground with or without a gait aid’; and, iv) are adults capable of providing consent (using the Short Portable Mental Status Questionnaire ).

Exclusion criteria

They will be excluded if they have moderate to severe receptive aphasia as determined by a score of <7/10 on the comprehension component of the Frenchay Screening Aphasia Test (Enderby et al., 1987). An addition to exclusions - added in March 2021- to exclude those with a walking speed of >1.4m/s and no fall in past year to ensure people with mobility or balance difficulties were included in the study.

Outcome results

None listed

Source: ANZCTR · Data processed: Mar 26, 2026