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Набор скоро начнётся NCT07629180

Feasibility of Structured Resistance Training After Lower Extremity Fracture

Без фазы С лечением Lower Extremity Fractures

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Structured Supervised Resistance Training and Coaching Program.
Кому может быть актуально
Состояния в реестре: Lower Extremity Fractures. Базовые параметры: 20 лет — 65 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Feasibility and Impact of a Structured, Supervised Exercise Program Following Lower Extremity Fracture: A Pilot Controlled Study

Обзор

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.

Подробное описание

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.

Вмешательства

  • Поведенческое Structured Supervised Resistance Training and Coaching Program
    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, po

Первичные конечные точки

  • Recruitment rate (participants enrolled per month) [Срок оценки: Up to 6 months]
  • Adherence to supervised resistance training program (% of prescribed sessions completed) [Срок оценки: Up to 6 months]
  • Participant retention rate (% completing follow up assessments) [Срок оценки: Up to 6 months]
Вторичные конечные точки (10)
  • Patient Specific Functional Scale Score [Срок оценки: 12, 18, 24, and 52 weeks post-surgery]
  • Health-related quality of life measured using SF-12 [Срок оценки: 12, 18, 24, and 52 weeks post-surgery]
  • Pain intensity measured using Numeric Pain Rating Scale (0-10) [Срок оценки: 12, 18, 24, and 52 weeks post-surgery]
  • Short Musculoskeletal Functional Assessment (SMFA) score [Срок оценки: 12, 18, 24, and 52 weeks post-surgery]
  • Functional Independence Test for Lower Extremity Injuries (FIX-IT) score [Срок оценки: 12, 18, 24, and 52 weeks post-surgery]
  • Lateral movement performance measured using Edgren Sidestep Test (seconds) [Срок оценки: 12, 18, 24, and 52 weeks post-surgery]
  • Body weight (kilograms) [Срок оценки: 12, 18, 24, and 52 weeks post-surgery]
  • Body mass index (BMI, kg/m²) [Срок оценки: 12, 18, 24, and 52 weeks post-surgery]
  • Thigh circumference measured in centimeters [Срок оценки: 12, 18, 24, and 52 weeks post-surgery]
  • Lower extremity muscle strength measured by exercise research team (force output) [Срок оценки: 12, 18, 24, and 52 weeks post-surgery]

Критерии участия

Критерии включения

  • 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

Критерии исключения

  • 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Нерандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Поддерживающая терапия

Центры проведения

Канада · 1 центр
  • London Health Sciences Centre — London

Идентификаторы

NCT: NCT07629180 · RETRAIN Study · LHSCRI

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗