Amputation of Lower Limb Below KneeRELOADNCT07817381
REsistance and LOADing Exercise for Bone Health
A study testing Resistance and high-impact exercise training in people with Amputation of Lower Limb Below Knee and Amputation, Traumatic, run by Defence Medical Rehabilitation Centre, UK at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years, men only
- Conditions the study is for
- Amputation of Lower Limb Below Knee, Amputation, Traumatic, Amputation, Limb Loss
- What is being tested?
- Resistance and high-impact exercise training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- 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)
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site, 1 recruiting
- Recruiting
Defence Medical Rehabilitation Centre, Stanford Hall
Loughborough
Marina De Vecchis
About this study
Official title: 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.
- Being tested
- Resistance and high-impact exercise training
- Keywords
- Below-knee prosthesis, Lower limb amputation, Weight-bearing training, Telehealth, Bone health
- Medical subject headings
- Amputation, Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance and high-impact exercise trainingBehavioural
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).
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Resistance and high-impact exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adverse events (i.e., safety of the intervention)
The number, seriousness, and severity of adverse events reported during the exercise program.
Measured: 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.
Measured: Through study completion, an average of 1 year
Compliance
Determined from individual training diaries. 100% compliance = completion of all exercise sessions
Measured: 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.
Measured: 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.
Measured: Week 2 to week 9
Secondary outcomes (2)
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).
Measured: 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).
Measured: Baseline (week 1) and follow-up (week 10)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Amputation of Lower Limb Below KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single arm pre-test/post-test feasibility and safety study with within-subject repeated measures.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Defence Medical Rehabilitation Centre, UK
- Sponsor type
- Other government
- Collaborators
- Imperial College London, University of Dublin, Trinity College
- Responsible party
- Principal investigator, Marina De Vecchis, Defence Medical Rehabilitation Centre, UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07817381
- Sponsor's protocol ID
- 2469/MODREC/26
- Acronym
- RELOAD
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2026
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07817381
- Acronym / sponsor ID
- RELOAD / 2469/MODREC/26
- Keywords
- Below-knee prosthesis, Lower limb amputation, Weight-bearing training, Telehealth, Bone health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Defence Medical Rehabilitation Centre, UKOther government
- Collaborators
- Imperial College London, University of Dublin, Trinity College
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 14 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single arm pre-test/post-test feasibility and safety study with within-subject repeated measures.
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention | Experimental | Behavioral: Resistance and high-impact exercise trainingParticipants will complete an eight-week home-based resistance and high-impact weight-bearing exercise program twice a week, with tele-supervision. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Resistance and high-impact exercise trainingEach 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). | Behavioural | Exercise Intervention |
Primary outcome
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.
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.
Compliance
Time frame: Week 2 to week 9
Determined from individual training diaries. 100% compliance = completion of all exercise sessions
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.
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.
2 secondary outcomes
Neuromuscular performance
Time frame: Baseline (week 1) and follow-up (week 10)
Hip muscles strength
Time frame: Baseline (week 1) and follow-up (week 10)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance and high-impact exercise training in people with Amputation of Lower Limb Below Knee and Amputation, Traumatic, run by Defence Medical Rehabilitation Centre, UK at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Higher Scientific Officer, PhD (+44 (0)1509 251500 ext. 3401, marina.devecchis100@mod.gov.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adverse events (i.e., safety of the intervention) (time frame: Through study completion, an average of 10 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.