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, Rosie Lampitt, Tony Fouweather, Joanne Gray, Dorothy Coe, Jennifer Wilkinson, Sheena Gawler, Lex D de Jong, Heather Waterman, Vincent Deary, Michael Clarke, Steve W. Parry

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Abstract

Background: Visually 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 investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of an adaptation of the Falls Management Exercise Programme (FaME) for VIOP, delivered in the community.
Methods: Two-centre randomised 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 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 selfreported compliance to the home exercises. Adherence with course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call.
Results: 82 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 both safe with 76% attending nine or more classes. Median time for home exercise was 50 minutes 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.
Conclusions: The intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups 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.
Original languageEnglish
JournalBMC Geriatrics
DOIs
Publication statusPublished - 12 Dec 2018

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Randomized Controlled Trials
Fear
Cost-Benefit Analysis
Quality of Life
Research Personnel
Outcome Assessment (Health Care)
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Keywords

  • falls prevention
  • intervention
  • exercise
  • vision
  • visual impairment
  • feasibility study

Cite this

Adams, Nicola ; Skelton, Dawn A ; Howel, Denise ; Bailey, Cathy ; Lampitt, Rosie ; Fouweather, Tony ; Gray, Joanne ; Coe, Dorothy ; Wilkinson, Jennifer ; Gawler, Sheena ; de Jong, Lex D ; Waterman, Heather ; Deary, Vincent ; Clarke, Michael ; Parry, Steve W. / 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. In: BMC Geriatrics. 2018.
@article{885b9b5a4eac4d95978786c9b5d8a74b,
title = "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",
abstract = "Background: Visually 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 investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of an adaptation of the Falls Management Exercise Programme (FaME) for VIOP, delivered in the community.Methods: Two-centre randomised 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 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 selfreported compliance to the home exercises. Adherence with course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call.Results: 82 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 both safe with 76{\%} attending nine or more classes. Median time for home exercise was 50 minutes 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.Conclusions: The intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups was unsurprising, given it was a pilot study, but there may have been other contributoryfactors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial.",
keywords = "falls prevention, intervention, exercise, vision, visual impairment, feasibility study",
author = "Nicola Adams and Skelton, {Dawn A} and Denise Howel and Cathy Bailey and Rosie Lampitt and Tony Fouweather and Joanne Gray and Dorothy Coe and Jennifer Wilkinson and Sheena Gawler and {de Jong}, {Lex D} and Heather Waterman and Vincent Deary and Michael Clarke and Parry, {Steve W.}",
note = "Acceptance in SAN OA article, funding note: This project was funded by the Public Health Research Programme of the National Institute for Health Research, (NIHR) United Kingdom, Health Promotion Interventions for People with Impairments Programme (project Number: 12/81/07).",
year = "2018",
month = "12",
day = "12",
doi = "10.1186/s12877-018-0998-6",
language = "English",
journal = "BMC Geriatrics",
issn = "1471-2318",
publisher = "BioMed Central",

}

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. / Adams, Nicola; Skelton, Dawn A; Howel, Denise; Bailey, Cathy; Lampitt, Rosie; Fouweather, Tony; Gray, Joanne; Coe, Dorothy; Wilkinson, Jennifer; Gawler, Sheena; de Jong, Lex D; Waterman, Heather; Deary, Vincent; Clarke, Michael; Parry, Steve W.

In: BMC Geriatrics, 12.12.2018.

Research output: Contribution to journalArticle

TY - JOUR

T1 - 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

AU - Adams, Nicola

AU - Skelton, Dawn A

AU - Howel, Denise

AU - Bailey, Cathy

AU - Lampitt, Rosie

AU - Fouweather, Tony

AU - Gray, Joanne

AU - Coe, Dorothy

AU - Wilkinson, Jennifer

AU - Gawler, Sheena

AU - de Jong, Lex D

AU - Waterman, Heather

AU - Deary, Vincent

AU - Clarke, Michael

AU - Parry, Steve W.

N1 - Acceptance in SAN OA article, funding note: This project was funded by the Public Health Research Programme of the National Institute for Health Research, (NIHR) United Kingdom, Health Promotion Interventions for People with Impairments Programme (project Number: 12/81/07).

PY - 2018/12/12

Y1 - 2018/12/12

N2 - Background: Visually 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 investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of an adaptation of the Falls Management Exercise Programme (FaME) for VIOP, delivered in the community.Methods: Two-centre randomised 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 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 selfreported compliance to the home exercises. Adherence with course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call.Results: 82 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 both safe with 76% attending nine or more classes. Median time for home exercise was 50 minutes 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.Conclusions: The intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups was unsurprising, given it was a pilot study, but there may have been other contributoryfactors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial.

AB - Background: Visually 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 investigate the feasibility of conducting a definitive randomised controlled trial (RCT) of an adaptation of the Falls Management Exercise Programme (FaME) for VIOP, delivered in the community.Methods: Two-centre randomised 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 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 selfreported compliance to the home exercises. Adherence with course content (fidelity) by instructors was assessed by a researcher. Adverse events were collected in a weekly phone call.Results: 82 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 both safe with 76% attending nine or more classes. Median time for home exercise was 50 minutes 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.Conclusions: The intervention, FaME, was implemented successfully for VIOP and all progression criteria for a main trial were met. The lack of difference between groups was unsurprising, given it was a pilot study, but there may have been other contributoryfactors including suboptimal exercise dose and apparent low risk of falls in participants. These issues need addressing for a future trial.

KW - falls prevention

KW - intervention

KW - exercise

KW - vision

KW - visual impairment

KW - feasibility study

U2 - 10.1186/s12877-018-0998-6

DO - 10.1186/s12877-018-0998-6

M3 - Article

JO - BMC Geriatrics

JF - BMC Geriatrics

SN - 1471-2318

ER -