Accidental FallNCT04078529
Falls Prevention for Visually Impaired Older People
A study testing 5 day falls prevention training, Home exercise programme and Environmental Assessment in people with Accidental Fall and Visual Impairment, run by Blind Veterans UK at 1 site in United Kingdom.
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… Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Fall, Visual Impairment, Fall
- What is being tested?
- 5 day falls prevention training, Home exercise programme and Environmental Assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2020to Mar 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 65 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Blind Veterans UK
Llandudno, Conwy, LL30 1UT
Catherine Wood, MSc PT, 01492 868737, kate.guilford-wood@blindveterans.org.uk
Charlotte Hunt, BSc OT, 01492 868722, charlotte.hunt@blindveterans.org.uk
About this study
Official title: Efficacy of a Tailored Exercise Programme and Home Evaluation for Falls Prevention in Older People With a Visual Impairment
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.
Read the 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.
- Conditions
- Accidental Fall, Visual Impairment, Fall
- Being tested
- 5 day falls prevention training, Home exercise programme, Environmental Assessment
- Medical subject headings
- Vision Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 day falls prevention trainingOther
Intensive training on balance, gait re-education, functional activities, backwards chaining and postural control, completed at 0 and 12 weeks.
Home exercise programmeOther
A modified version of the Falls Management Exercise programme (FaME) provided in written or audio format and completed over 12 weeks.
Environmental AssessmentOther
Use of the Homefast assessment tool to reduce risk of falls at home.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group | Experimental | 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. Receives: Other: 5 day falls prevention training; Other: Home exercise programme; Other: Environmental Assessment |
| Comparison group[ | Active comparator | This group will complete the home exercise programme only. Receives: Other: Home exercise programme; Other: Environmental Assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Incidence of falls
Participant's self-reported incidence of falls or near misses
Measured: 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.
Measured: 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
Measured: At 0 and 12 weeks in the programme
Secondary outcomes (2)
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.
Measured: Completed at the time of consent to participate in the study and at week 0 and 12 in the programme.
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.
Measured: Completed at weeks 0 and 12 of the programme.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study startJan 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Accidental FallStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single-blind randomised control trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Blind Veterans UK
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Catherine Wood, Blind Veterans UK
- Investigators
- Catherine Wood, MSc PT, Principal investigator, Blind Veterans UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078529
- Sponsor's protocol ID
- FPIS0.1
- Status last verified
- Sep 2019
- First submitted
- 30 Aug 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30348098Huang 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.
PubMed 28167744Cuevas-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.
PubMed 29031339Skelton 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.
PubMed 27486124Graham 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.
PubMed 26891644Yeung 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.
PubMed 24480023Martin 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.
PubMed 23449007Tricco 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.
PubMed 29114830Klein 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.
PubMed 31221939Adams 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.
PubMed 30541483
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of a Tailored Exercise Programme and Home Evaluation for Falls Prevention in Older People With a Visual Impairment
- ClinicalTrials.gov ID
- NCT04078529
- Acronym / sponsor ID
- FPIS0.1
- Conditions
- Accidental Fall, Visual Impairment, Fall
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Blind Veterans UKUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 6 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Single-blind randomised control trial
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Other: 5 day falls prevention training, Other: Home exercise programme, Other: Environmental AssessmentThis 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 comparator | Other: Home exercise programme, Other: Environmental AssessmentThis group will complete the home exercise programme only. |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 5 day falls prevention trainingIntensive training on balance, gait re-education, functional activities, backwards chaining and postural control, completed at 0 and 12 weeks. | Other | Intervention group |
| Home exercise programmeA modified version of the Falls Management Exercise programme (FaME) provided in written or audio format and completed over 12 weeks. | Other | Comparison group[, Intervention group |
| Environmental AssessmentUse of the Homefast assessment tool to reduce risk of falls at home. | Other | Comparison group[, Intervention group |
Primary outcome
Change in Incidence of falls
Time frame: Fortnightly reporting throughout the 12 week programme.
Participant's self-reported incidence of falls or near misses
Change in Fear of falling
Time frame: 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
Time frame: At 0 and 12 weeks in the programme
Standing balance as measured by the 4-point balance test
2 secondary outcomes
Risk of falls
Time frame: Completed at the time of consent to participate in the study and at week 0 and 12 in the programme.
Confidence in functional ability
Time frame: Completed at weeks 0 and 12 of the programme.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Background: PubMed 30348098Bjerk 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.
- Background: PubMed 28167744Huang 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.
- Background: PubMed 29031339Cuevas-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.
- Background: PubMed 27486124Skelton 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.
- Background: PubMed 26891644Graham 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.
- Background: PubMed 24480023Yeung 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.
- Background: PubMed 23449007Martin 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.
- Background: PubMed 29114830Tricco 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.
- Background: PubMed 31221939Klein 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 publication: PubMed 30541483Adams 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Catherine Wood, MSc PT principal investigator
Blind Veterans UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 day falls prevention training, Home exercise programme and Environmental Assessment in people with Accidental Fall and Visual Impairment, run by Blind Veterans UK at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Catherine Wood, MSc PT (01492 868737, kate.guilford-wood@blindveterans.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Incidence of falls (time frame: Fortnightly reporting throughout the 12 week programme.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04078529, which also lists 10 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2019.