None listed
Conditions
Brief summary
Visually impaired older people are increasing in number and have significant ongoing morbidity including risk of falls, but are neglected in regard to falls prevention programs. We aim to evaluate the effectiveness of the Lifestyle approach to reducing Falls through Exercise (LiFE) program to prevent falls and improve function in older people with vision impairment compared to usual care, delivered through specialist Orientation and Mobility Instructors. Secondary aims are to establish the cost-effectiveness of the LiFE program compared to usual care and to identify determinants of the success of the LiFE program and implementation issues in the vision impaired population. We will conduct a randomized controlled trial evaluating the LiFE program in older people with visual impairment in NSW and ACT in collaboration with Guide Dogs NSW/ACT, a leading community service organisation for people with vision impairment. A total of 588 participants will be recruited through Guide Dogs client database, and randomized to receive either the LiFE intervention or usual care (control group). Guide Dogs' Orientation and Mobility Instructors will receive training in delivering the LiFE program, which will be delivered to those in the intervention group. Social and demographic characteristics and visual and physical status and will be assessed at baseline, and physical status reassessed at 12 months to characterise the study cohort.. Falls will be self-reported on a monthly basis. Physical activity will be measured using actigraphy at baseline, 3 and 12 months. A sample of 30 participants in the intervention group will be interviewed after completing the program to determine how well the LiFE program concepts are integrated into daily activity. An economic evaluation will be modeled from a health service provider perspective, with data collected on costs to deliver the LiFE program, in-patient hospital admissions, emergency department presentations and other health and community service contact, The primary outcome measures will be the rate of falls over the 12 months following randomization and the Late Life Disability and Function Index.. The secondary outcomes will be falls requiring medical care and the rate of falls per steps taken.
Interventions
The LiFE program is a structured approach to improving the balance and strength of people at high risk of falls. The program is designed in such a way that participants incorporate the 8 balance and 7 strength activities into their daily lives and routines to gradually form habits (Clemson, Munro, Fiatarone Singh 2013). Lally and Gardner (2011) argue that habit formation is largely dependent on repetitive behavior being conducted in a consistent environment. Participants of the LiFE program are taught these activities within their own home thus maintaining the consistency of the environment (Clemson et al 2012; Lally and Gardner 2011). Additionally daily routines provide the ‘cue’ that participants need to promote the performance of the activity (Lally and Gardner 2011). The balance activities are the tandem stand, tandem walking, one-leg stand, leaning from side-to-side, leaning forwards and backwards, stepping over objects, stepping over objects sideways and stepping in different directions. The strength activities aim to increase the load on the legs and include; bending knees, sit to stand, standing on toes and heels, walking up stairs, walking sideways and tightening muscles (Clemson, Munro, Fiatarone Singh 2013). These activities will be taught by Orientation and Mobility Instructors employed by Guide Dogs NSW/ACT. These instructors are familiar in working with the vision impaired population and will thus appropriately tailor these activities to the needs of the participants. The LIFE program will be adminstered over 5 home visits (with one each week) as well as 2 booster visits and 2 phone calls (one each fortnight as the participant becomes more familiar with the program) over the course of 3 months. It is expected that each of the 5 home visits will be conducted over an hour, whereas the booster visits and phone calls should not take longer than half an hour. Overall the duration of the program is 3 months. However there will also be a follow up assessment at the end of the 3 month period and at 12 months from the baseline assessment, to measure any improvements to the participants’ balance and strength abilities. Thus the total duration of the study is 12 months.
Sponsors
The George Institute for Global Health
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
50 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Clients of Guide Dogs NSW/ACT with vision impairment severe enough to interfere with activities of daily living, aged 50 years or older, living in the community or self-care unit of a retirement village, able to understand English well enough to undertake study procedures, no more than two errors on the Short Portable Mental Status Questionnaire and no diagnosis of dementia, not scheduled for cataract surgery in the next 12 months,
Exclusion criteria
Nursing home or hostel residents, those currently engaging in a falls or exercise program.
Outcome results
None listed