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Falls Prevention for Visually Impaired Older People

Primary Purpose

Accidental Fall, Visual Impairment, Fall

Status

Unknown status

Phase

Not Applicable

Locations

United Kingdom

Study Type

Interventional

Intervention

5 day falls prevention training

Home exercise programme

Environmental Assessment

About this trial

This is an interventional prevention trial for Accidental Fall

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Blind Veterans UK

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intervention group

Comparison group[

Arm Description

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.

This group will complete the home exercise programme only.

Outcomes

Primary Outcome Measures

Change in Incidence of falls

Participant's self-reported incidence of falls or near misses

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.

Change in Objective Balance

Standing balance as measured by the 4-point balance test

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT04078529

First Posted

August 30, 2019

Last Updated

September 2, 2019

Sponsor

Blind Veterans UK

1. Study Identification

Unique Protocol Identification Number

NCT04078529

Brief Title

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

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Unknown status

Study Start Date

January 2020 (Anticipated)

Primary Completion Date

December 2020 (Anticipated)

Study Completion Date

March 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Blind Veterans UK

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Accidental Fall, Visual Impairment, Fall

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Single-blind randomised control trial

Masking

Participant

Masking Description

Participants will be unaware whether they are in the comparison or intervention group.

Allocation

Randomized

Enrollment

32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

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.

Arm Title

Comparison group[

Arm Type

Active Comparator

Arm Description

This group will complete the home exercise programme only.

Intervention Type

Other

Intervention Name(s)

5 day falls prevention training

Intervention Description

Intensive training on balance, gait re-education, functional activities, backwards chaining and postural control, completed at 0 and 12 weeks.

Intervention Type

Other

Intervention Name(s)

Home exercise programme

Intervention Description

A modified version of the Falls Management Exercise programme (FaME) provided in written or audio format and completed over 12 weeks.

Intervention Type

Other

Intervention Name(s)

Environmental Assessment

Intervention Description

Use of the Homefast assessment tool to reduce risk of falls at home.

Primary Outcome Measure Information:

Title

Change in Incidence of falls

Description

Participant's self-reported incidence of falls or near misses

Time Frame

Fortnightly reporting throughout the 12 week programme.

Title

Change in Fear of falling

Description

Time Frame

Completed at the time of consent to participate in the study and at week 0 and week 12 of the programme

Title

Change in Objective Balance

Description

Standing balance as measured by the 4-point balance test

Time Frame

At 0 and 12 weeks in the programme

Secondary Outcome Measure Information:

Title

Risk of falls

Description

Time Frame

Completed at the time of consent to participate in the study and at week 0 and 12 in the programme.

Title

Confidence in functional ability

Description

Time Frame

Completed at weeks 0 and 12 of the programme.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Catherine Wood, MSc PT

Phone

01492 868737

kate.guilford-wood@blindveterans.org

First Name & Middle Initial & Last Name or Official Title & Degree

Charlotte Hunt, BSc OT

Phone

01492 868722

charlotte.hunt@blindveterans.org.uk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catherine Wood, MSc PT

Organizational Affiliation

Blind Veterans UK

Official's Role

Principal Investigator

Facility Information:

Facility Name

Blind Veterans UK

City

Llandudno

State/Province

Conwy

ZIP/Postal Code

LL30 1UT

Country

United Kingdom

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Catherine Wood, MSc PT

Phone

01492 868737

kate.guilford-wood@blindveterans.org.uk

First Name & Middle Initial & Last Name & Degree

Charlotte Hunt, BSc OT

Phone

01492 868722

charlotte.hunt@blindveterans.org.uk

First Name & Middle Initial & Last Name & Degree

Catherine Wood, MSc PT

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30348098

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.

Results Reference

background

PubMed Identifier

28167744

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.

Results Reference

background

PubMed Identifier

29031339

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.

Results Reference

background

PubMed Identifier

27486124

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.

Results Reference

background

PubMed Identifier

26891644

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.

Results Reference

background

PubMed Identifier

24480023

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.

Results Reference

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PubMed Identifier

23449007

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.

Results Reference

background

PubMed Identifier

29114830

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. Erratum In: JAMA. 2021 Apr 27;325(16):1682.

Results Reference

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PubMed Identifier

31221939

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.

Results Reference

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PubMed Identifier

30541483

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.

Results Reference

result

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Falls Prevention for Visually Impaired Older People

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