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 |
| Secondary identifying numbers | 17324 |
- 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
Scientific
Clinical Age Research Unit
Denmark Hill
London
SE5 9RS
United Kingdom
| julie.whitney@nhs.net |
Study information
| Study design | Randomised; Interventional; Design type: Prevention, Treatment |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | GP practice |
| Study type | Treatment |
| 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 | 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 study start date | 20/10/2014 |
| Completion date | 23/04/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Senior |
| Sex | Both |
| Target number of participants | Planned Sample Size: 240; UK Sample Size: 240; Description: 120 intervention and 120 usual care |
| 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
- England
- United Kingdom
Study participating centre
Clinical Age Research Unit
London
SE5 9RS
United Kingdom
SE5 9RS
United Kingdom
Sponsor information
King College Hospital and Kings College London (UK)
Hospital/treatment centre
Hospital/treatment centre
Child Health
Denmark Hill
London
SE5 9RS
England
United Kingdom
"ROR" |
https://ror.org/0220mzb33 |
|---|
Funders
Funder type
Government
NIHR - Clinical Academic Training; Grant Codes: CAT CL-2013-04-007
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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.
