REsistance and LOADing Exercise for Bone Health (RELOAD)
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Não aplicável
Contactos e Locais
Contato de estudo
- Nome: Higher Scientific Officer, PhD
- Número de telefone: 3401 +44 (0)1509 251500
- E-mail: marina.devecchis100@mod.gov.uk
Locais de estudo
-
-
-
Loughborough, Reino Unido
- Recrutamento
- Defence Medical Rehabilitation Centre, Stanford Hall
-
Contato:
- Marina De Vecchis
-
-
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Outro
- Alocação: N / D
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
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.
|
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).
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Adverse events (i.e., safety of the intervention)
Prazo: 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
Prazo: 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
Prazo: Week 2 to week 9
|
Determined from individual training diaries.
100% compliance = completion of all exercise sessions
|
Week 2 to week 9
|
|
Acceptability
Prazo: 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
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Neuromuscular performance
Prazo: 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
Prazo: 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)
|
Colaboradores e Investigadores
Patrocinador
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Estimado)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2469/MODREC/26
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .