Falls Prevention for Visually Impaired Older People

Not Applicable

• Conditions: Accidental Fall; Visual Impairment; Fall
• Interventions: Other: Home exercise programme; Other: 5 day falls prevention training; Other: Environmental Assessment

• Registration Number: NCT04078529
• Lead Sponsor: Blind Veterans UK

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2019-08-30
• Status Verified: 2019-09
• Study First Submitted QC: 2019-09-02
• Last Update Submitted: 2019-09-02
• Study First Posted: 2019-09-06
• Last Update Posted: 2019-09-06
• Study Start: 2020-01
• Primary Completion: 2020-12
• Study Completion: 2021-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Comparison group[	Home exercise programme	This group will complete the home exercise programme only.
Comparison group[	Environmental Assessment	This group will complete the home exercise programme only.
Intervention group	5 day falls prevention training	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.
Intervention group	Environmental Assessment	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.
Intervention group	Home exercise programme	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.

Primary Outcome Measures

Name	Time	Method
Change in Fear of falling	Completed at the time of consent to participate in the study and at week 0 and week 12 of the programme	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.
Change in Objective Balance	At 0 and 12 weeks in the programme	Standing balance as measured by the 4-point balance test
Change in Incidence of falls	Fortnightly reporting throughout the 12 week programme.	Participant's self-reported incidence of falls or near misses

Secondary Outcome Measures

Name	Time	Method
Risk of falls	Completed at the time of consent to participate in the study and at week 0 and 12 in the programme.	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.
Confidence in functional ability	Completed at weeks 0 and 12 of the programme.	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.

Trial Locations

Locations (1)

Blind Veterans UK; 🇬🇧 Llandudno, Conwy, United Kingdom