REsistance and LOADing Exercise for Bone Health

NCT07817381 | Recruiting

• 1 other identifier: 2469/MODREC/26
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Amputation of Lower Limb Below Knee; Amputation, Traumatic; Amputation, Limb Loss

Keywords

Below-knee prosthesis; Lower limb amputation; Weight-bearing training; Telehealth; Bone health

Outcome Measures

Primary Outcomes (5)

• Adverse events (i.e., safety of the intervention)

  The number, seriousness, and severity of adverse events reported during the exercise program.

  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.

  Through study completion, an average of 1 year

• Compliance

  Determined from individual training diaries. 100% compliance = completion of all exercise sessions

  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.

  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.

  Week 2 to week 9

Secondary Outcomes (2)

• Neuromuscular performance

  Baseline (week 1) and follow-up (week 10)

• Hip muscles strength

  Baseline (week 1) and follow-up (week 10)

Study Arms (1)

Exercise Intervention

EXPERIMENTAL

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

Interventions

Resistance and high-impact exercise training BEHAVIORAL

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).

Exercise Intervention

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Defence Medical Rehabilitation Centre, UK: lead
• Imperial College London: collaborator
• University of Dublin, Trinity College: collaborator

Study Sites (1)

Defence Medical Rehabilitation Centre, Stanford Hall

Loughborough, United Kingdom

RECRUITING

MeSH Terms

Conditions

Amputation, Traumatic

Condition Hierarchy (Ancestors)

Wounds and Injuries

Central Study Contacts

Higher Scientific Officer, PhD

CONTACT

+44 (0)1509 251500; marina.devecchis100@mod.gov.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Higher Scientific Officer

Model Details: A single arm pre-test/post-test feasibility and safety study with within-subject repeated measures.

Study Record Dates

• First Submitted: September 8, 2026
• First Posted: September 14, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 14, 2026

Record last verified: 2026-09

Locations

GB (1)