Contact information
Type
Scientific
Primary contact
Dr Julie Whitney
ORCID ID
Contact details
Clinical Age Research Unit
Denmark Hill
London
SE5 9RS
United Kingdom
-
julie.whitney@nhs.net
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
17324
Study information
Scientific title
Frame Fit. A randomised controlled trial to determine the acceptability, safety and efficacy of a falls prevention exercise programme for walking frame users
Acronym
Frame Fit - falls prevention for frame users
Study hypothesis
Falls are common among people with walking and balance difficulties, particularly those who have to use a walking frame to get around. Exercise programmes to improve balance effectively prevent falls. However, no programme has been designed to include the frame in the exercise or provided exercises to address the unique challenges to mobility and balance experienced by frame users.
This project will test a fall prevention exercise programme developed specifically for frame users. Frame users will be randomly assigned to receive either this exercise or usual care. Balance, mobility and falls will then be compared between these two groups.
A small additional exploratory study will look at mechanisms underlying balance in people who use walking frames and whether balance exercise alters these mechanisms.
Ethics approval
14/LO/0556
Study design
Randomised; Interventional; Design type: Prevention, Treatment
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Condition
Topic: Primary Care, Ageing; Subtopic: Ageing, Ageing; Disease: All Diseases, All Ageing
Intervention
The participants are randomised to intervention and control group:
1. Frame fit exercise programme: Muscle strengthening and balance training exercises incorporating the walking
frame.; Follow Up Length: 12 month(s); Study Entry : Registration and One or More Randomisations
2. Control group: Usual care
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measures
Falls; Timepoint(s): 12 months from baseline
Secondary outcome measures
1. Fear of falling (FES-I); Timepoint(s): Baseline and 6 month follow up
2. Frailty index; Timepoint(s): Baseline and 6 month follow up
3. Gait (6 metre walk and timed up and go); Timepoint(s): Baseline and 6 month follow up
4. Muscle strength (grip and sit to stand); Timepoint(s): Baseline and 6 month follow up
5. Physical activity (IPEQ); Timepoint(s): baseline and 6 month follow up
6. Quality of life (EQ5D); Timepoint(s): Baseline and 6 month follow up
7. Standing balance; Timepoint(s): Baseline and 6 month follow up
Overall trial start date
20/10/2014
Overall trial end date
29/02/2016
Reason abandoned
Eligibility
Participant inclusion criteria
1. Uses a walking frame for the majority of walking and standing tasks on a daily basis
2. Aged >65
3. Able to follow simple commands e.g. hold onto this chair with one hand and lift up your right leg
Participant type
Patient
Age group
Senior
Gender
Both
Target number of participants
Planned Sample Size: 240; UK Sample Size: 240; Description: 120 intervention and 120 usual care
Participant exclusion criteria
1. Unable to walk 6 metres
2. Unable to stand from a chair independently
3. Diagnosis or dementia or MMSE<24 and not living with a full time carer who can commit to helping with the
exercise
4. Terminal illness or likely to live for <6 months
5. Non-weight bearing
6. Less than 6 weeks following an episode of delirium
7. Lacking in mental capacity to consent
Recruitment start date
20/10/2014
Recruitment end date
29/02/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Clinical Age Research Unit
London
SE5 9RS
United Kingdom
Funders
Funder type
Government
Funder name
NIHR - Clinical Academic Training; Grant Codes: CAT CL-2013-04-007
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