Feasibility of Structured Resistance Training After Lower Extremity Fracture
2026年6月1日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
介入
入学 (推定)
40
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：David Sanders, MD, FRCS(C) Principal Investigator
- 電話番号：519-685-8500
- メール：david.sanders@lhsc.on.ca
研究場所
-
-
Ontario
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London、Ontario、カナダ
- London Health Sciences Centre
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コンタクト：
- LHSCRI LHSCRI
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：支持療法
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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介入なし：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Recruitment rate (participants enrolled per month)
時間枠：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)
時間枠：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)
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Patient Specific Functional Scale Score
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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)
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (推定)
2026年6月15日
一次修了 (推定)
2030年6月15日
研究の完了 (推定)
2031年6月15日
試験登録日
最初に提出
2026年5月19日
QC基準を満たした最初の提出物
2026年6月1日
最初の投稿 (実際)
2026年6月5日
学習記録の更新
投稿された最後の更新 (実際)
2026年6月5日
QC基準を満たした最後の更新が送信されました
2026年6月1日
最終確認日
2026年5月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- RETRAIN Study
- LHSCRI (その他の識別子：LHSCRI)
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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