Falls Prevention for Visually Impaired Older People

Fall Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04078529
• Other study ID #: FPIS0.1
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: March 2021

Study information

• Verified date: September 2019
• Source: Blind Veterans UK
• Contact: Catherine Wood, MSc PT
• Phone: 01492 868737
• Email: kate.guilford-wood[@]blindveterans.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: March 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accidental Fall
• Fall
• Vision Disorders
• Vision, Low
• Visual Impairment

Intervention

Other:
• 5 day falls prevention training
Intensive training on balance, gait re-education, functional activities, backwards chaining and postural control, completed at 0 and 12 weeks.
• Home exercise programme
A modified version of the Falls Management Exercise programme (FaME) provided in written or audio format and completed over 12 weeks.
• Environmental Assessment
Use of the Homefast assessment tool to reduce risk of falls at home.

Locations

Country	Name	City	State
United Kingdom	Blind Veterans UK	Llandudno	Conwy

Sponsors (1)

Lead Sponsor	Collaborator
Blind Veterans UK

Country where clinical trial is conducted

United Kingdom, 

References & Publications (10)

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 exerci — View 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. — View 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. Review. — View 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. — View 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. Review. — View 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 Jun 1. pii: AT5817. [Epub ahead of print] — View 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. Review. — View 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. — View 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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Incidence of falls	Participant's self-reported incidence of falls or near misses	Fortnightly reporting throughout the 12 week programme.
Primary	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
Primary	Change in Objective Balance	Standing balance as measured by the 4-point balance test	At 0 and 12 weeks in the programme
Secondary	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.
Secondary	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.