Frame Fit. A randomised controlled trial to determine the acceptability, safety and efficacy of a falls prevention exercise programme for walking frame users

ISRCTN	ISRCTN57645734
DOI	https://doi.org/10.1186/ISRCTN57645734
Protocol serial number	17324
Sponsor	King College Hospital and Kings College London (UK)
Funder	NIHR - Clinical Academic Training; Grant Codes: CAT CL-2013-04-007

Submission date: 11/09/2014
Registration date: 11/09/2014
Last edited: 24/08/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Injury, Occupational Diseases, Poisoning

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Julie Whitney
Scientific

Clinical Age Research Unit
Denmark Hill
London
SE5 9RS
United Kingdom

Email	julie.whitney@nhs.net

Study information

Primary study design	Interventional
Study design	Randomised; Interventional; Design type: Prevention, Treatment
Secondary study design	Randomised controlled trial
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
Study acronym	Frame Fit - falls prevention for frame users
Study objectives	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(s)	14/LO/0556
Health condition(s) or problem(s) studied	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
Primary outcome measure(s)	Falls; Timepoint(s): 12 months from baseline
Key secondary outcome measure(s)	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
Completion date	23/04/2019

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	All
Target sample size at registration	240
Key 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
Key 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
Date of first enrolment	20/10/2014
Date of final enrolment	24/04/2018

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Clinical Age Research Unit

London
SE5 9RS
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
HRA research summary			28/06/2023	No	No

Editorial Notes

24/08/2020: The following changes have been made:
1. The recruitment end date has been changed from 29/02/2016 to 24/04/2018.
2. The overall trial end date has been changed from 29/02/2016 to 23/04/2019.
28/03/2018: No publications found, verifying study status with principal investigator.