Feasibility of Structured Resistance Training After Lower Extremity Fracture
2026년 6월 1일 업데이트: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Feasibility and Impact of a Structured, Supervised Exercise Program Following Lower Extremity Fracture: A Pilot Controlled Study
Adults recovering from surgically managed diaphyseal femur or tibia fractures often experience persistent weakness, pain, and functional limitations despite successful fracture healing.
This prospective, non-randomized pilot study evaluates the feasibility and acceptability of a structured, supervised resistance training program initiated approximately 12 weeks after surgery, compared with usual postoperative care alone.
The study will assess recruitment, adherence, retention, and protocol fidelity, and will collect exploratory patient-reported and physical function outcomes to inform the design of a future randomized controlled trial.
연구 개요
상태
아직 모집하지 않음
정황
상세 설명
This is a prospective, non-randomized, controlled pilot feasibility study enrolling adults aged 20 to 65 years with isolated diaphyseal femur or tibia fractures treated surgically with locked intramedullary nail fixation.
Participants will be recruited from routine postoperative fracture clinic visits and enrolled approximately 10 to 14 weeks after injury, once fracture healing has progressed sufficiently to allow full weight bearing and independent participation in supervised exercise.
연구 유형
중재적
등록 (추정된)
40
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: David Sanders, MD, FRCS(C) Principal Investigator
- 전화번호: 519-685-8500
- 이메일: david.sanders@lhsc.on.ca
연구 장소
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Ontario
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London, Ontario, 캐나다
- London Health Sciences Centre
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연락하다:
- LHSCRI LHSCRI
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
아니
설명
Inclusion Criteria:
- Adults aged 20 to 65 years
- Diaphyseal femur or tibia fracture treated surgically with locked intramedullary nail fixation
- Cleared for full weight bearing with adequate fracture healing and no major complications
- Able to provide written informed consent in English without an interpreter
- Able to understand instructions and safely participate in supervised exercise
Exclusion Criteria:
- Bilateral fractures or open fractures; Polytrauma
- Cognitive impairment affecting participation or ability to provide informed consent
- Severe cardiac, respiratory, or neurological conditions that preclude exercise participation
- Chronic pain syndromes or recent opioid dependence
- Pre-existing severe lower limb disability
- Requires an interpreter for consent or cannot follow exercise instructions independently
- Unable to provide consent due to language barrier
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Structured Resistance Training Program
Participants with surgically managed diaphyseal femur or tibia fractures who participate in a 12-week structured, supervised resistance training and activity program initiated approximately 12 weeks after surgery, in addition to usual postoperative care.
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A 12-week structured exercise intervention delivered at a community fitness facility by trained study personnel.
The program includes 24 supervised small-group resistance training sessions (two per week, 50-75 minutes each), 12 weekly one-to-one coaching sessions (~30 minutes each), and a brief daily home activity program (10-15 minutes per day).
The exercise program follows a criteria-based, progressive strength and conditioning framework including mobility, neuromuscular control, strength, power, and fatigue-resistance components.
All sessions are supervised by study personnel, and no gym staff are involved in intervention delivery or data collection.
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간섭 없음: Usual Care Control
Participants with surgically managed diaphyseal femur or tibia fractures who receive usual postoperative care without participation in the structured supervised exercise or coaching program.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Recruitment rate (participants enrolled per month)
기간: Up to 6 months
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Feasibility will be assessed by the number of participants enrolled per month during the recruitment period.
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Up to 6 months
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Adherence to supervised resistance training program (% of prescribed sessions completed)
기간: Up to 6 months
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Adherence will be calculated as the proportion of completed training sessions out of the total prescribed sessions.
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Up to 6 months
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Participant retention rate (% completing follow up assessments)
기간: Up to 6 months
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Retention will be defined as the proportion of participants who complete all scheduled follow-up assessments.
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Up to 6 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Patient Specific Functional Scale Score
기간: 12, 18, 24, and 52 weeks post-surgery
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Patient-reported functional status assessed using the Patient-Specific Functional Scale (PSFS), in which participants rate difficulty performing self-selected activities on a 0-10 scale.
Higher scores indicate better function.
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12, 18, 24, and 52 weeks post-surgery
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Health-related quality of life measured using SF-12
기간: 12, 18, 24, and 52 weeks post-surgery
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Health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12).
Higher scores indicating better health status.
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12, 18, 24, and 52 weeks post-surgery
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Pain intensity measured using Numeric Pain Rating Scale (0-10)
기간: 12, 18, 24, and 52 weeks post-surgery
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Pain intensity measured using a numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain).
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12, 18, 24, and 52 weeks post-surgery
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Short Musculoskeletal Functional Assessment (SMFA) score
기간: 12, 18, 24, and 52 weeks post-surgery
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Self-reported musculoskeletal function assessed using the Short Musculoskeletal Functional Assessment (SMFA) questionnaire.
Scores are reported according to standardized scoring procedures, with higher scores indicating greater functional limitation.
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12, 18, 24, and 52 weeks post-surgery
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Functional Independence Test for Lower Extremity Injuries (FIX-IT) score
기간: 12, 18, 24, and 52 weeks post-surgery
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Lower extremity functional performance assessed using the Functional Independence Test for Lower Extremity Injuries (FIX-IT), a performance-based measure of functional mobility following lower extremity injury.
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12, 18, 24, and 52 weeks post-surgery
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Lateral movement performance measured using Edgren Sidestep Test (seconds)
기간: 12, 18, 24, and 52 weeks post-surgery
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Lateral movement and agility assessed using the Edgren Sidestep Test.
Performance is recorded as time to completion in seconds.
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12, 18, 24, and 52 weeks post-surgery
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Body weight (kilograms)
기간: 12, 18, 24, and 52 weeks post-surgery
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Body weight measured in kilograms using a calibrated scale.
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12, 18, 24, and 52 weeks post-surgery
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Body mass index (BMI, kg/m²)
기간: 12, 18, 24, and 52 weeks post-surgery
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Body mass index calculated as weight in kilograms divided by height in meters squared.
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12, 18, 24, and 52 weeks post-surgery
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Thigh circumference measured in centimeters
기간: 12, 18, 24, and 52 weeks post-surgery
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Thigh circumference measured in centimeters using a standardized tape measure to assess lower extremity muscle girth.
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12, 18, 24, and 52 weeks post-surgery
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Lower extremity muscle strength measured by exercise research team (force output)
기간: 12, 18, 24, and 52 weeks post-surgery
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Lower extremity muscle strength assessed using standardized strength testing procedures performed by the exercise research team.
Strength outcomes will be reported as force output using consistent measurement methods.
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12, 18, 24, and 52 weeks post-surgery
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (추정된)
2026년 6월 15일
기본 완료 (추정된)
2030년 6월 15일
연구 완료 (추정된)
2031년 6월 15일
연구 등록 날짜
최초 제출
2026년 5월 19일
QC 기준을 충족하는 최초 제출
2026년 6월 1일
처음 게시됨 (실제)
2026년 6월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 6월 5일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 6월 1일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
- RETRAIN Study
- LHSCRI (기타 식별자: LHSCRI)
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