Cargando…
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
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 adapt the existing Falls Management Exercise (FaME) programme for VIOP, delivered in the community, and to investigate the feasibility o...
Autores principales: | , , , , , , , , , , , , , , |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
BioMed Central
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6292024/ https://www.ncbi.nlm.nih.gov/pubmed/30541483 http://dx.doi.org/10.1186/s12877-018-0998-6 |
_version_ | 1783380330720264192 |
---|---|
author | Adams, Nicola Skelton, Dawn A. Howel, Denise Bailey, Cathy Lampitt, Rosy Fouweather, Tony Gray, Joanne Coe, Dorothy Wilkinson, Jennifer Gawler, Sheena de Jong, Lex D. Waterman, Heather Deary, Vincent Clarke, Michael Parry, Steve W |
author_facet | Adams, Nicola Skelton, Dawn A. Howel, Denise Bailey, Cathy Lampitt, Rosy Fouweather, Tony Gray, Joanne Coe, Dorothy Wilkinson, Jennifer Gawler, Sheena de Jong, Lex D. Waterman, Heather Deary, Vincent Clarke, Michael Parry, Steve W |
author_sort | Adams, Nicola |
collection | PubMed |
description | 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 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. METHODS: Two-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. RESULTS: Eighteen 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. 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 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 REGISTRATION: Current Controlled Trials ISRCTN ID: 16949845 Registered: 21 May 2015. |
format | Online Article Text |
id | pubmed-6292024 |
institution | National Center for Biotechnology Information |
language | English |
publishDate | 2018 |
publisher | BioMed Central |
record_format | MEDLINE/PubMed |
spelling | pubmed-62920242018-12-17 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, Rosy Fouweather, Tony Gray, Joanne Coe, Dorothy Wilkinson, Jennifer Gawler, Sheena de Jong, Lex D. Waterman, Heather Deary, Vincent Clarke, Michael Parry, Steve W BMC Geriatr Research Article 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 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. METHODS: Two-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. RESULTS: Eighteen 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. 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 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 REGISTRATION: Current Controlled Trials ISRCTN ID: 16949845 Registered: 21 May 2015. BioMed Central 2018-12-12 /pmc/articles/PMC6292024/ /pubmed/30541483 http://dx.doi.org/10.1186/s12877-018-0998-6 Text en © The Author(s). 2018 Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. |
spellingShingle | Research Article Adams, Nicola Skelton, Dawn A. Howel, Denise Bailey, Cathy Lampitt, Rosy 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 |
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 |
title_full | 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 |
title_fullStr | 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 |
title_full_unstemmed | 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 |
title_short | 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 |
title_sort | 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 |
topic | Research Article |
url | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6292024/ https://www.ncbi.nlm.nih.gov/pubmed/30541483 http://dx.doi.org/10.1186/s12877-018-0998-6 |
work_keys_str_mv | AT adamsnicola feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT skeltondawna feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT howeldenise feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT baileycathy feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT lampittrosy feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT fouweathertony feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT grayjoanne feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT coedorothy feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT wilkinsonjennifer feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT gawlersheena feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT dejonglexd feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT watermanheather feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT dearyvincent feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT clarkemichael feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy AT parrystevew feasibilityoftrialproceduresforarandomisedcontrolledtrialofacommunitybasedgroupexerciseinterventionforfallspreventionforvisuallyimpairedolderpeoplethevioletstudy |