Feasibility of Structured Resistance Training After Lower Extremity Fracture
1 de junio de 2026 actualizado por: 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.
Descripción general del estudio
Estado
Aún no reclutando
Condiciones
Intervención / Tratamiento
Descripción detallada
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.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
40
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: David Sanders, MD, FRCS(C) Principal Investigator
- Número de teléfono: 519-685-8500
- Correo electrónico: david.sanders@lhsc.on.ca
Ubicaciones de estudio
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Ontario
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London, Ontario, Canadá
- London Health Sciences Centre
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Contacto:
- LHSCRI LHSCRI
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
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
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Cuidados de apoyo
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: 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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Sin intervención: 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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Recruitment rate (participants enrolled per month)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Patient Specific Functional Scale Score
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Estimado)
15 de junio de 2026
Finalización primaria (Estimado)
15 de junio de 2030
Finalización del estudio (Estimado)
15 de junio de 2031
Fechas de registro del estudio
Enviado por primera vez
19 de mayo de 2026
Primero enviado que cumplió con los criterios de control de calidad
1 de junio de 2026
Publicado por primera vez (Actual)
5 de junio de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
5 de junio de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
1 de junio de 2026
Última verificación
1 de mayo de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Otros números de identificación del estudio
- RETRAIN Study
- LHSCRI (Otro identificador: LHSCRI)
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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