An interventional study of Resistance and high-impact exercise training in Amputation of Lower Limb Below Knee, Amputation, Traumatic and Amputation, Limb Loss, sponsored by Defence Medical Rehabilitation Centre, UK. Recruiting at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2026-09-14.
Sponsored by Defence Medical Rehabilitation Centre, UK · Not applicable, Interventional, and Other
Lower limb amputation, often resulting from military conflict and road traffic accidents, is associated with reduced hip bone mineral density (BMD) and increased risk of hip fractures. This bone loss is attributed to altered mechanical loading and is compounded by an increased falls risk in prosthesis users. While resistance and high-impact exercise interventions have proven effective in enhancing BMD in other populations, no studies have examined their role in amputees. Building on an international Delphi consensus guidelines, this study aims to assess the feasibility and safety of a novel home-based, tele-supervised resistance and high-impact exercise intervention in individuals with unilateral transtibial limb loss.
A convenience sample of 10 male prosthesis wearers from the ongoing ADVANCE Study will be involved in the study for 10 weeks and will undertake an 8-week, twice-weekly exercise program including resistance (squat, deadlift, overhead press) and impact-based activities (e.g., multidirectional jumps) (week 2 to week 9 of the study participation). Remote supervision will be provided twice weekly during the first week of exercise and once weekly thereafter. The primary outcomes are feasibility (recruitment, retention, compliance, acceptability, tolerance) and safety (adverse event monitoring). Secondary outcomes include changes in hip muscle strength and neuromuscular performance, assessed at baseline (week 1 of the study participation) and post-intervention (week 10 of the study participation) using isokinetic dynamometry, and force plates, respectively.
This study will provide the first evidence on the feasibility and safety of a targeted exercise intervention to stabilise or improve BMD in unilateral transtibial amputees. Findings will inform the design of a subsequent randomised controlled trial to evaluate efficacy, with potential to shape clinical rehabilitation programmes for military and civilian amputee populations at risk of low BMD and related complications.
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's planned enrollment of 10 is below the median of 15 across 75 interventional studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →Defence Medical Rehabilitation Centre, UK is the lead sponsor of 5 studies on the registry; 4 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will complete an eight-week home-based resistance and high-impact weight-bearing exercise program twice a week, with tele-supervision.
Behavioral: Resistance and high-impact exercise training
Each exercise session consists of three resistance training exercises (dumbbell squat, dumbbell deadlift, dumbbell overhead press; for each exercise, 3 sets of 8-12 reps, at 70% of the participant's predicted one repetition maximum) and three impact exercises (vertical, forward, lateral jumps; 2 sets of 10 repetitions each and 2-3 minutes rest between sets).
Adverse events (i.e., safety of the intervention)
The number, seriousness, and severity of adverse events reported during the exercise program.
Time frame: Through study completion, an average of 10 weeks
Recruitment and retention rates
Recruitment rate (percentage of enrolled participants out of eligible participants) and retention rates (percentage of enrolled participants who complete the exercise programme to the end). Reasons for non-enrolment, and attrition (withdrawals or dropouts) will be noted systematically throughout the study.
Time frame: Through study completion, an average of 1 year
Compliance
Determined from individual training diaries. 100% compliance = completion of all exercise sessions
Time frame: Week 2 to week 9
Acceptability
Measured via the Theoretical Framework of Acceptability questionnaire. This scale consists of 8 questions, 1 from each of the TFA constructs asked on a 5-point Likert scale for each question (1 = low acceptability; 5 = high acceptability), for a total composite acceptability score of 40.
Time frame: Week 10
Tolerance
After each exercise session, participants will be asked to complete a post-exercise questionnaire within the training diary containing the Borg Rate of Perceived Exertion, a scale from 6 to 20, where a higher number means more perceived exertion.
Time frame: Week 2 to week 9
Neuromuscular performance
This will be tested using a pair of portable force plates (1000 Hz recording frequency; Hawkin Dynamics, Portland, Maine, USA). Force outputs from an Isometric Mid-Thigh Pull (IMTP).
Time frame: Baseline (week 1) and follow-up (week 10)
Hip muscles strength
Hip strength. An IsoKinetic Dynamometer (IKD) (System 4, Biodex Medical Systems Inc., New York, USA) will be used for measuring the isometric peak torque of hip flexors, extensors, adductors and abductors (on both sides, tested in a random order).
Time frame: Baseline (week 1) and follow-up (week 10)
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Defence Medical Rehabilitation Centre, UK