Clinical trial NCT04078529: Falls Prevention for Visually Impaired Older People
Official title: Efficacy of a Tailored Exercise Programme and Home Evaluation for Falls Prevention in Older People With a Visual Impairment
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Accidental Fall
Visual Impairment
Fall
Lead sponsor: Blind Veterans UK
Sponsor class: OTHER
First posted: 2019-09-06
Enrollment: 32
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single-blind randomised control trial
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Incidence of falls
timeFrame: Fortnightly reporting throughout the 12 week programme.
measure: Change in Fear of falling
timeFrame: Completed at the time of consent to participate in the study and at week 0 and week 12 of the programme
measure: Change in Objective Balance
timeFrame: At 0 and 12 weeks in the programme
Secondary outcomes:
measure: Risk of falls
timeFrame: Completed at the time of consent to participate in the study and at week 0 and 12 in the programme.
measure: Confidence in functional ability
timeFrame: Completed at weeks 0 and 12 of the programme.
Other outcomes:
Locations:
city: Llandudno
country: United Kingdom
facility: Blind Veterans UK
state: Conwy
Study officials:
affiliation: Blind Veterans UK
name: Catherine Wood, MSc PT
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bjerk M, Brovold T, Skelton DA, Bergland A. Associations between health-related quality of life, physical function and fear of falling in older fallers receiving home care. BMC Geriatr. 2018 Oct 22;18(1):253. doi: 10.1186/s12877-018-0945-6.
citation: Huang ZG, Feng YH, Li YH, Lv CS. Systematic review and meta-analysis: Tai Chi for preventing falls in older adults. BMJ Open. 2017 Feb 6;7(2):e013661. doi: 10.1136/bmjopen-2016-013661.
citation: Cuevas-Trisan R. Balance Problems and Fall Risks in the Elderly. Phys Med Rehabil Clin N Am. 2017 Nov;28(4):727-737. doi: 10.1016/j.pmr.2017.06.006.
citation: Skelton DA, Bailey C, Howel D, Cattan M, Deary V, Coe D, de Jong LD, Gawler S, Gray J, Lampitt R, Wilkinson J, Adams N. Visually Impaired OLder people's Exercise programme for falls prevenTion (VIOLET): a feasibility study protocol. BMJ Open. 2016 Aug 2;6(8):e011996. doi: 10.1136/bmjopen-2016-011996.
citation: Graham V, Napier-Dovorany K. Multifactoral measures of fall risk in the visually impaired population: A pilot study. J Bodyw Mov Ther. 2016 Jan;20(1):104-109. doi: 10.1016/j.jbmt.2015.06.012. Epub 2015 Jul 3.
citation: Yeung PY, Chan W, Woo J. A community-based Falls Management Exercise Programme (FaME) improves balance, walking speed and reduced fear of falling. Prim Health Care Res Dev. 2015 Apr;16(2):138-46. doi: 10.1017/S1463423614000024. Epub 2014 Jan 30.
citation: Martin JT, Wolf A, Moore JL, Rolenz E, DiNinno A, Reneker JC. The effectiveness of physical therapist-administered group-based exercise on fall prevention: a systematic review of randomized controlled trials. J Geriatr Phys Ther. 2013 Oct-Dec;36(4):182-93. doi: 10.1519/JPT.0b013e3182816045.
citation: Tricco AC, Thomas SM, Veroniki AA, Hamid JS, Cogo E, Strifler L, Khan PA, Robson R, Sibley KM, MacDonald H, Riva JJ, Thavorn K, Wilson C, Holroyd-Leduc J, Kerr GD, Feldman F, Majumdar SR, Jaglal SB, Hui W, Straus SE. Comparisons of Interventions for Preventing Falls in Older Adults: A Systematic Review and Meta-analysis. JAMA. 2017 Nov 7;318(17):1687-1699. doi: 10.1001/jama.2017.15006.
citation: Klein PJ, Baumgarden J, Schneider R. Qigong and Tai Chi as Therapeutic Exercise: Survey of Systematic Reviews and Meta-Analyses Addressing Physical Health Conditions. Altern Ther Health Med. 2019 Sep;25(5):48-53.
citation: Adams N, Skelton DA, Howel D, Bailey C, Lampitt R, Fouweather T, Gray J, Coe D, Wilkinson J, Gawler S, de Jong LD, Waterman H, Deary V, Clarke M, Parry SW. Feasibility of trial procedures for a randomised controlled trial of a community based group exercise intervention for falls prevention for visually impaired older people: the VIOLET study. BMC Geriatr. 2018 Dec 12;18(1):307. doi: 10.1186/s12877-018-0998-6.