Exercise for falls prevention in lower limb amputees

Plain English summary of protocol

Background and study aims
In the UK, there are approximately 5-6,000 new referrals to prosthetic services centres every year. Approximately 70% of lower-limb amputations are related to vascular disease (e.g., vascular-related diabetes) and typically occur in men over 60 years of age. Moreover, 52% of lower limb amputees fall each year, and 75% fall two or more times. There has been a lot of work done on exercise for improved function in older adults but no published journal articles about exercise as a tool for falls prevention and better function in lower-limb amputees. Moreover, many prosthetic rehabilitation centres do not offer structured exercise classes for lower-limb amputees.
The aim of this study is to undertake a targeted exercise programme in lower-limb amputees and assess how well it helps preventing falls and improving daily function and performance.

Who can participate?
Adult below-knee and above-knee amputees who wear their prosthesis on a daily basis and have completed a gait retraining or rehabilitation programme at some point.

What does the study involve?
Participants will be placed into either an exercise group or a control group. Those in the exercise group will take part in an exercise programme (exercises becoming progressively difficult), partly supervised (once or twice a week) and partly home-based (once or twice a week). Participants in the control group will be asked not to change their normal weekly physical activity levels.
All participants will undergo biomechanical testing before and after the exercise period. Quality of life, prosthetic function and satisfaction, and balance confidence will also be monitored.

What are the possible benefits and risks of participating?
The biomechanical testing will not provide direct benefit to the participants. However, it will inform the individualised design of the exercise programme and thus provide important information regarding the effectiveness of the intervention and potentially impact on future exercise programmes. Participants may request lay feedback on their performance on the biomechanical tests, and this will be provided upon request.
Participants allocated to the exercise group will benefit directly from participation in this study, as they will be given an exercise programme designed for lower limb amputees may experience one or more of the following: improved gait, balance, muscle strength and flexibility; reduced falls over a 1-year period; improved mental well-being and quality of life. Participants may also benefit from weekly social interaction with other lower limb amputees during the group-based exercise sessions.
Participants in the non-exercise (control) group may still benefit as knowledge gained through our study will be shared, and an exercise programme may be designed for them upon completion of the study. Participants in the control group are very important as their results will inform the findings of this research and help us establish whether our exercise programme was successful. Our goal is to encourage the development of a community-based exercise group that will directly benefit participants in this study and other similar individuals. Following the completion of the study, and if the exercise intervention proves beneficial, the establishment of a long-term, falls prevention group-based programme could be developed in the local area, and all participants are likely to benefit from this, from a musculoskeletal and quality of life perspective.
There are some small risks and burdens when participating in this study, including: an additional time commitment will be required by all participants to complete the biomechanical testing, weekly exercise diaries, and questionnaires, including at 12 months follow-up; participants in the exercise group are also asked to commit more free time to participate in the study (on average over 2.5-3 hours per week for 12 weeks); all participants may be inconvenienced somewhat by filling in the weekly exercise diaries during the 12-week exercise period (all participants will complete this, even those in the non-exercise group). This will come at no cost to the participants, as pre-paid return envelopes will be provided; participants in the exercise group may experience muscle/joint soreness after each exercise session if they are not used to physical activity. Participants are at somewhat higher risk of falling as they perform activities that challenge their balance as part of the exercise intervention. However, the group-based sessions will be supervised by a suitably trained exercise instructor with first aid training.
To control for these risks, the investigators promise that: all health and safety risks will be minimised during the biomechanical testing by adherence to correct health and safety guidelines in the laboratory, including adequate lighting, walkways free from obstructions, nonslip surfaces, the presence of handrails on staircases and armrests on chairs, safety harness during the balance test. proximity of first aid kit and first aid trained personnel; we will ensure that participants understand these risks and that they minimise risk of falling by performing the exercises gently at first, in an area free from obstruction, whilst wearing proper footwear and clothing, and within close contact of another person or mobile phone in case they were to fall during home-based exercise. Most importantly, participants will be asked to demonstrate that they know how to get up off the floor in case of a fall and to seek medical attention if needed; we will maintain weekly contact with the participants and ask for feedback about their progress. If any exercise causes them discomfort, it may be modified or replaced with another exercise.

Where is the study run from?
Hull and Yorkshire area (UK).

When is the study starting and how long is it expected to run for?
August 2014 to January 2017

Who is funding the study?
British Association of Chartered Physiotherapists in Amputee Rehabilitation (London, UK) and the Help for Health Trust (Hull, UK)

Who is the main contact?
Prof. Natalie Vanicek
n.vanicek@hull.ac.uk

Contact information

Study information

Eligibility

Locations

Countries of recruitment

• England
• United Kingdom

Study participating centre

Sponsor information

University of Hull
University/education

Cottingham Rd
Hull
HU67RX
England
United Kingdom

"ROR"	https://ror.org/04nkhwh30

Funders

Funder type

Charity

Results and Publications

Study outputs

Additional files

ISRCTN30210699_BasicResults_03Sep2020.pdf

uploaded 03/09/2020

Editorial Notes

23/11/2020: The following changes were made to the trial record:
1. The study hypothesis, interventions and contact details were updated.
2. The study design was changed from 'Single centre case control trial' to 'Randomized controlled trial'.
03/09/2020: The following changes were made to the trial record:
1. Publication reference added.
2. The total final enrolment was added.
3. The basic results of this trial have been uploaded as an additional file.