Falls Prevention for Visually Impaired Older People

Study Overview
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Brief Summary
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This study aims to examine the effectiveness of an intensive five day falls prevention training programme with a home evaluation and a home exercise programme, compared with a home evaluation and exercise programme alone for reducing incidence of falls and fear of falling, and improving confidence in functional ability and objective balance.

Detailed Description
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While previous research shows a clear link between visual impairment and increased risk and incidence of falls, as well as fear of falling, there is little research to investigate the effectiveness of falls prevention programmes for visually impaired populations. At the time of writing there were no studies identified that used this type of intensive training over a period of several days, rather most of the studies that exist have been conducted in community settings. This study will aim to compare the effectiveness of a comprehensive exercise programme aimed at improving balance, walking technique, postural control and ability to complete functional tasks, with a home exercise programme with either written or audio instructions.

Official Title
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Efficacy of a Tailored Exercise Programme and Home Evaluation for Falls Prevention in Older People With a Visual Impairment

Conditions
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Accidental Fall, Visual Impairment, Fall

Intervention / Treatment
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* Other: 5 day falls prevention training
* Other: Home exercise programme
* Other: Environmental Assessment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participant is able to mobilise with or without walking aids or hand-hold Participant has history of falls Any possible medical or pharmaceutical causes of falls have been investigated and excluded Participant has a diagnosed visual impairment Participant is aged 65 or over Participant's falls can not be attributed purely to their visual impairment Participant is a member of Blind Veterans UK Participant is physically able to take part in group and individual exercise sessions Participant is able to understand and follow verbal and/or written instructions Exclusion Criteria: Participant is under 65 years of age Participant is medically unwell or has a medical condition for which exercise is contraindicated Participant is currently involved in other falls prevention programmes Participant is predominantly a wheelchair user Participant is unable to understand or follow instruction from staff in English

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Single-blind randomised control trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>This group will complete a 5 day falls prevention training programme, followed by a 12 week home exercise programme, then a repeat 5 day training intervention. | Other: 5 day falls prevention training<br>* Intensive training on balance, gait re-education, functional activities, backwards chaining and postural control, completed at 0 and 12 weeks.<br>Other: Home exercise programme<br>* A modified version of the Falls Management Exercise programme (FaME) provided in written or audio format and completed over 12 weeks.<br>Other: Environmental Assessment<br>* Use of the Homefast assessment tool to reduce risk of falls at home.<br>|
| Active Comparator: Comparison group[<br>This group will complete the home exercise programme only. | Other: Home exercise programme<br>* A modified version of the Falls Management Exercise programme (FaME) provided in written or audio format and completed over 12 weeks.<br>Other: Environmental Assessment<br>* Use of the Homefast assessment tool to reduce risk of falls at home.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Incidence of falls | Participant's self-reported incidence of falls or near misses | Fortnightly reporting throughout the 12 week programme. | 
| Change in Fear of falling | The participant's self-reported level of fear about their risk of having a fall as indicated by completion of the Falls Efficacy Scale (FES-I), which scores from a minimum of 1 to a maximum of 4 on each item with a high score indicating a worse outcome. The lowest total score possible is 16 and the highest total score possible is 64. | Completed at the time of consent to participate in the study and at week 0 and week 12 of the programme | 
| Change in Objective Balance | Standing balance as measured by the 4-point balance test | At 0 and 12 weeks in the programme | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk of falls | The participant's likelihood of experiencing a fall as measured by the Falls Risk Assessment Tool (FRAT), which scores from a minimum of 0 to a maximum of 5, with a higher score indicating a worse outcome. | Completed at the time of consent to participate in the study and at week 0 and 12 in the programme. | 
| Confidence in functional ability | Self-reported confidence in ability to perform activities of daily living as recorded using the Activities-specific Balance Confidence (ABC) scale, which scores from a minimum of 0 to a maximum of 10 on each of the 16 items. An average is then taken from the scores, with a higher average indicating a better outcome. | Completed at weeks 0 and 12 of the programme. |