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.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Higher Scientific Officer, PhD
- 전화번호: 3401 +44 (0)1509 251500
- 이메일: marina.devecchis100@mod.gov.uk
연구 장소
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Loughborough, 영국
- 모병
- Defence Medical Rehabilitation Centre, Stanford Hall
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연락하다:
- Marina De Vecchis
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 다른
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Exercise Intervention
Participants will complete an eight-week home-based resistance and high-impact weight-bearing exercise program twice a week, with tele-supervision.
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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).
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Adverse events (i.e., safety of the intervention)
기간: Through study completion, an average of 10 weeks
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The number, seriousness, and severity of adverse events reported during the exercise program.
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Through study completion, an average of 10 weeks
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Recruitment and retention rates
기간: Through study completion, an average of 1 year
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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.
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Through study completion, an average of 1 year
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Compliance
기간: Week 2 to week 9
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Determined from individual training diaries.
100% compliance = completion of all exercise sessions
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Week 2 to week 9
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Acceptability
기간: Week 10
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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.
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Week 10
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Tolerance
기간: Week 2 to week 9
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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.
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Week 2 to week 9
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Neuromuscular performance
기간: Baseline (week 1) and follow-up (week 10)
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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).
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Baseline (week 1) and follow-up (week 10)
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Hip muscles strength
기간: Baseline (week 1) and follow-up (week 10)
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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).
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Baseline (week 1) and follow-up (week 10)
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- 2469/MODREC/26
약물 및 장치 정보, 연구 문서
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미국 FDA 규제 기기 제품 연구
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