Resistance and high-impact exercise for bone health in people with below-knee amputation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study will evaluate the feasibility and safety of a 10-week, home-based exercise program delivered with tele-supervision. Participants are 10 male British Armed Forces personnel with unilateral transtibial amputation who wear a prosthesis daily and can perform jumping on the prosthetic limb. The program runs for 8 weeks, with twice-weekly sessions focusing on resistance exercises (e.g., squats, deadlifts, overhead presses) and high-impact activities to load the hip region. Outcomes will inform whether this approach can enhance hip bone mineral density and bone health in this population. The study builds on international Delphi guidelines and leverages the ongoing ADVANCE cohort for recruitment.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Current or previous British Armed Forces Personnel who are members of the ADVANCE Study (Bennett et al., 2020)
* Male
* Aged ≥ 18 years and ≤ 55 years
* History of unilateral below knee limb loss due to trauma
* Ambulating with their current prosthetic limb for a minimum of six months
* Full-time prosthesis wearer (i.e., wearing the prosthesis every day, for most of the day, removing it mainly for sleeping or when resting for extended periods)
* Able to walk independently using a prosthetic limb
* Able to perform jumping activities on the prosthetic limb
* Able to communicate in English
* Access to the internet and a computer/smartphone
* Able to drive/be driven to and from the testing location for the purpose of transporting the exercise equipment provided by the research team

Exclusion Criteria:

* Additional limb loss of the upper and/or lower limb other than the transtibial limb loss
* Cardiovascular disease, diabetes, neurological injury
* Sickle cell disease
* Neurodegenerative disease
* Limb loss as a result of a vascular condition
* Orthopaedic or neurological issues in the intact/non-amputated limb
* Additional neuromusculoskeletal pathology which may affect walking
* Pain, irritation, swelling, or skin complaints in the residual limb which inhibit prosthetic use
* Diseases affecting bone metabolism (other than osteoporosis/osteopenia; for example, osteomalacia, Paget's disease, hyper/hypoparathyroidism, osteogenesis imperfecta)
* Traumatic head injury resulting in cognitive disability
* Lack of capacity to give consent
* Any contraindications to exercise and/or resistance training
* Continuous immobilisation for seven days or more in the month prior to attendance
* Use of assistive walking device when utilising the, other than a prosthetic limb
* Unable to regularly attend the supervised training program

Where it's running

• Defence Medical Rehabilitation Centre, Stanford Hall
  Loughborough, United Kingdom Recruiting

Study contacts

• Study coordinator: Higher Scientific Officer, PhD
• Email: marina.devecchis100@mod.gov.uk
• Phone: +44 (0)1509 251500

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.