Condition category
Not Applicable
Date applied
20/05/2015
Date assigned
21/05/2015
Last edited
26/10/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 April 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

Contact information

Type

Scientific

Primary contact

Ms Rosy Lampitt

ORCID ID

Contact details

University of Newcastle upon Tyne
Neurosurgical Trials Unit
3-4 Claremont Terrace
Newcastle University
Newcastle upon Tyne
NE2 4AE
United Kingdom

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 below 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 measures

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

30/04/2016

Reason abandoned

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

Sponsor information

Organisation

University of Northumbria at Newcastle

Sponsor details

Psychology
Queen Victoria Road
Newcastle Upon Tyne
NE1 4LP
United Kingdom

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Government

Funder name

NIHR Public Health Research (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes