Condition category
Injury, Occupational Diseases, Poisoning
Date applied
11/09/2014
Date assigned
11/09/2014
Last edited
11/09/2014
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

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

Sponsor information

Organisation

King College Hospital and Kings College London (UK)

Sponsor details

Child Health
Denmark Hill
London
SE5 9RS
United Kingdom

Sponsor type

Hospital/treatment centre

Website

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

Publication citations

Additional files

Editorial Notes