Plain English Summary
Background and study aims
Falls and fear of falling have a big impact on older people’s lives. Many people stop going out altogether, or reduce their activity so that they are much less active than they used to be. This in turn has a negative impact on their social life and general well-being. Research has shown that exercise programmes can help with this, by building up a person’s confidence as well as their physical strength and stamina. This can help make them less likely to fall, more likely to keep active and more likely to have a better quality of life. However, there are a lot of older people who are visually impaired or blind and cannot easily access or participate in these kinds of exercise programmes. The aim of this study is to work with a group of older people with vision problems to adapt an existing exercise programme designed to help prevent falls so that it can also be used by people who are visually impaired. To do this, a group of older, visually impaired people will work alongside health and exercise professionals to adapt the programme and agree on ways of measuring how well it works (e.g. measuring confidence, number of falls, fear of falling and general health) for those with sight loss. The main focus of this small study will be to see if older people with sight loss in Newcastle and Glasgow are prepared to join in and stick with the exercise programme and complete the assessments. The results of this study will be used to see whether a larger study could be carried out.
Who can participate?
Adults aged 60 and over with visual impairment.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 (intervention group) take part in a 12-week exercise programme. Those in group 2 (control group) are given standard primary health care advice. Measurements, including confidence, fear of falling, number of falls etc. are taken at the start of the trial, at the end of the exercise programme, and again 6 months later.
What are the possible benefits and risks of participating?
Not provided at time of registration.
Where is the study run from?
University of Newcastle upon Tyne (UK)
When is the study starting and how long is it expected to run for?
May 2015 to May 2016
Who is funding the study?
National Institute for Health Research (NIHR) - Public Health Research (UK)
Who is the main contact?
Ms R Lampitt
Trial website
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
18789
Study information
Scientific title
Visually Impaired OLder people’s Exercise programme for falls prevention (VIOLET): a feasibility study
Acronym
VIOLET
Study hypothesis
This study will assess the feasibility and acceptability of, and adherence to, an exercise programme aimed to increase fitness in older people with sight loss. The exercise programme aims to decrease physical injury from falls and increase confidence in participants.
Ethics approval
Ref: 15/NE/0057
Study design
Randomised interventional study
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Quality of life
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Fitness of visually impaired older people
Intervention
1. Treatment group takes part in an adapted exercise programme designed for older, visually impaired people for 12 weeks
2. Control group receives standard care
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Fear of falling measured using Short Falls Efficacy Scale – International (FES-I) at baseline, 12 weeks and 24 weeks.
Secondary outcome measures
Not available at time of registration
Overall trial start date
01/05/2015
Overall trial end date
23/05/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age >60 years
2. Attend a low vision clinic and/or are members of organisations for the visually impaired such as NSBP in Newcastle or Visibility in Glasgow
3. Live in their own home
4. Can walk indoors without the help of another person but may use a walking aid such as a stick
5. Can walk outdoors but may need the help of another and/or walking aid
6. Physically able to take part in a group exercise class
7. Participant has given informed consent (as appropriate to each older person with visual impairment) to participate in the study prior to any study-specific procedures
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
UK Sample Size: 80
Participant exclusion criteria
1. Unable to comprehend or follow simple movement instructions in English (to an extent of being unable to follow simple movement instructions)
2. Acute or uncontrolled medical problems which the participant’s General Practitioner considers would exclude then from undertaking the exercise programme (e.g. uncontrolled heart disease, poorly controlled diabetes, acute systemic illness, neurological problems, severe chronic obstructive pulmonary disease (COPD)) in addition to visual impairment
3. Conditions requiring a specialist exercise programme e.g. uncontrolled epilepsy, severe neurological disease or impairment, unable to maintain a seated upright position or unable to move independently indoors
4. Current involvement in other falls prevention exercise programmes (but not excluding walking programmes), investigational studies or trials
Recruitment start date
01/05/2015
Recruitment end date
30/04/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University of Newcastle upon Tyne
Neurosurgical Trials Unit
3-4 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom
Funders
Funder type
Government
Funder name
Public Health Research Programme
Alternative name(s)
NIHR Public Health Research Programme, PHR
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2018 results in https://www.ncbi.nlm.nih.gov/pubmed/30541483