REsistance and LOADing Exercise for Bone Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age18-55
SponsorDefence Medical Rehabilitation Centre, UK
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Resistance and high-impact exercise training
BehavioralEach 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).
Treatment groups
10 Participants
are divided into 1 treatment groupGroup A: Exercise InterventionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 weeks2
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 year3
Compliance
Determined from individual training diaries. 100% compliance = completion of all exercise sessions
Time frame
Week 2 to week 94
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 10Secondary outcomes
1
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)2
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)Sponsors and contacts
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Defence Medical Rehabilitation Centre, UK
Lead sponsor
Imperial College London
Collaborator
University of Dublin, Trinity College
Collaborator
Source ClinicalTrials.gov