Evidence map›Paper›PMID 30541483›Full record

Trial reportBMC geriatrics2018

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.

Nicola Adams, Dawn A Skelton, Denise Howel, Cathy Bailey, Rosy Lampitt, Tony Fouweather, Joanne Gray, Dorothy Coe, Jennifer Wilkinson, Sheena Gawler and 5 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in BMC geriatrics, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04078529 (Efficacy of a Tailored Exercise Programme and Home Evaluation for Falls Prevention in Older People With a Visual Impairment), which is not on this map. Cited by 10 papers, 3 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
10citing papers in PubMed, 3 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT04078529 naunknown statusnot on this mapstarted 2020, after this paper: background citation

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

TypeinterventionalSponsorBlind Veterans UKRan2020 to 2021Enrolled32ConditionsAccidental Fall, Visual Impairment, FallArms5 day falls prevention training, Home exercise programme, Environmental Assessment
3 · Its place in the literature

Who cites it

10 citing papers in PubMed, 3 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Article
  5. Article
  6. Article
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  8. Observational
  9. Article
  10. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

15 authors.

Nicola AdamsFaculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK. nicola.adams@northumbria.ac.uk.ORCID 0000-0002-2692-0177
Dawn A SkeltonInstitute of Applied Health Research, School of Health & Life Sciences, Glasgow Caledonian University, Glasgow, UK.
Denise HowelInstitute of Health and Society, Baddiley-Clark Building, Newcastle University, Newcastle upon Tyne, UK.
Cathy BaileyFaculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK.
Rosy LampittNewcastle Clinical Trials Unit, Newcastle University, 1-4 Claremont Terrace, Newcastle upon Tyne, UK.
Tony FouweatherInstitute of Health and Society, Baddiley-Clark Building, Newcastle University, Newcastle upon Tyne, UK.
Joanne GrayFaculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK.
Dorothy CoeFaculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK.
Jennifer WilkinsonNewcastle Clinical Trials Unit, Newcastle University, 1-4 Claremont Terrace, Newcastle upon Tyne, UK.
Sheena GawlerFaculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK.
Lex D de JongSchool of Physiotherapy and Exercise Science, Curtin University, Bentley, Western Australia.
Heather WatermanHealthcare Sciences, Cardiff University, Cardiff, UK.
Vincent DearyFaculty of Health and Life Sciences, Northumbria University, Newcastle upon Tyne, NE7 7XA, UK.
Michael ClarkeNewcastle Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Steve W ParryInstitute for Ageing and Health, Newcastle University, Newcastle upon Tyne, UK.

Funding

Department of Health 12/181/07Department of Health PHR/12/181/07
6 · The paper itself

Abstract

backgroundVisually impaired older people (VIOP) have a higher risk of falling than their sighted peers, and are likely to avoid physical activity. The aim was to adapt the existing Falls Management Exercise (FaME) programme for VIOP, delivered in the community, and to investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of this adapted intervention.

methodsTwo-centre randomised mixed methods pilot trial and economic evaluation of the adapted group-based FaME programme for VIOP versus usual care. A one hour exercise programme ran weekly over 12 weeks at the study sites (Newcastle and Glasgow), delivered by third sector (voluntary and community) organisations. Participants were advised to exercise at home for an additional two hours over the week. Those randomised to the usual activities group received no intervention. Outcome measures were completed at baseline, 12 and 24 weeks. The potential primary outcome was the Short Form Falls Efficacy Scale - International (SFES-I). Participants' adherence was assessed by reviewing attendance records and self-reported compliance to the home exercises. Adherence with the course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call.

resultsEighteen participants, drawn from community-living VIOP were screened; 68 met the inclusion criteria; 64 participants were randomised with 33 allocated to the intervention and 31 to the usual activities arm. 94% of participants provided data at the 12 week visit and 92% at 24 weeks. Adherence was high. The intervention was found to be safe with 76% attending nine or more classes. Median time for home exercise was 50 min per week. There was little or no evidence that fear of falling, balance and falls risk, physical activity, emotional, attitudinal or quality of life outcomes differed between trial arms at follow-up.

conclusionsThe intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups on fear of falling was unsurprising given it was a pilot study but there may have been other contributory factors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial.

trial registrationCurrent Controlled Trials ISRCTN ID: 16949845 Registered: 21 May 2015.

Indexed as

Residence CharacteristicsAccidental FallsAgedAged, 80 and overExerciseExercise TherapyFearFeasibility StudiesFemaleHumansMaleMiddle AgedPersons with Visual DisabilitiesPilot ProjectsQuality of LifeExerciseFalls managementFeasibility clinical trialOlder peopleVisual impairment

Identifiers

PMID30541483
PMCPMC6292024

What OpenQuestion holds

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.