Falls Prevention for Visually Impaired Older People
Efficacy of a Tailored Exercise Programme and Home Evaluation for Falls Prevention in Older People With a Visual Impairment
1 other identifier
interventional
32
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 30, 2019
CompletedFirst Posted
Study publicly available on registry
September 6, 2019
CompletedStudy Start
First participant enrolled
January 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2021
CompletedSeptember 6, 2019
September 1, 2019
11 months
August 30, 2019
September 2, 2019
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (2)
Risk of falls
Completed at the time of consent to participate in the study and at week 0 and 12 in the programme.
Confidence in functional ability
Completed at weeks 0 and 12 of the programme.
Study Arms (2)
Intervention group
EXPERIMENTALThis 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.
Comparison group[
ACTIVE COMPARATORThis group will complete the home exercise programme only.
Interventions
Intensive training on balance, gait re-education, functional activities, backwards chaining and postural control, completed at 0 and 12 weeks.
A modified version of the Falls Management Exercise programme (FaME) provided in written or audio format and completed over 12 weeks.
Use of the Homefast assessment tool to reduce risk of falls at home.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Blind Veterans UK
Llandudno, Conwy, LL30 1UT, United Kingdom
Related Publications (10)
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.
PMID: 30348098BACKGROUNDHuang 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.
PMID: 28167744BACKGROUNDCuevas-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.
PMID: 29031339BACKGROUNDSkelton 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.
PMID: 27486124BACKGROUNDGraham 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.
PMID: 26891644BACKGROUNDYeung 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.
PMID: 24480023BACKGROUNDMartin 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.
PMID: 23449007BACKGROUNDTricco 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.
PMID: 29114830BACKGROUNDKlein 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.
PMID: 31221939BACKGROUNDAdams 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.
PMID: 30541483RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Catherine Wood, MSc PT
Blind Veterans UK
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Masking Details
- Participants will be unaware whether they are in the comparison or intervention group.
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Physiotherapist, Health and Wellbeing Dept.
Study Record Dates
First Submitted
August 30, 2019
First Posted
September 6, 2019
Study Start
January 1, 2020
Primary Completion
December 1, 2020
Study Completion
March 1, 2021
Last Updated
September 6, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share