REsistance and LOADing Exercise for Bone Health (RELOAD)

September 11, 2026 updated by: Marina De Vecchis, Defence Medical Rehabilitation Centre, UK

The Feasibility and Safety of a Resistance and High-impact Home Exercise Program to Improve Bone Mineral Density in Individuals With Post-traumatic, Unilateral Transtibial Limb Loss

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United Kingdom
      • Loughborough, United Kingdom
        • Recruiting
        • Defence Medical Rehabilitation Centre, Stanford Hall
        • Contact:
          • Marina De Vecchis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise Intervention
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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events (i.e., safety of the intervention)
Time Frame: Through study completion, an average of 10 weeks
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
Time Frame: Through study completion, an average of 1 year
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
Time Frame: Week 2 to week 9
Determined from individual training diaries. 100% compliance = completion of all exercise sessions
Week 2 to week 9
Acceptability
Time Frame: Week 10
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
Time Frame: Week 2 to week 9
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Neuromuscular performance
Time Frame: Baseline (week 1) and follow-up (week 10)
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).
Baseline (week 1) and follow-up (week 10)
Hip muscles strength
Time Frame: Baseline (week 1) and follow-up (week 10)
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).
Baseline (week 1) and follow-up (week 10)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Defence Medical Rehabilitation Centre, UK

Collaborators

Imperial College London
University of Dublin, Trinity College

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

September 8, 2026

First Submitted That Met QC Criteria

September 11, 2026

First Posted (Actual)

September 14, 2026

Study Record Updates

Last Update Posted (Actual)

September 14, 2026

Last Update Submitted That Met QC Criteria

September 11, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2469/MODREC/26

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe