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Feasibility of Structured Resistance Training After Lower Extremity Fracture

1 juin 2026 mis à jour par: 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.

Aperçu de l'étude

Statut

Pas encore de recrutement

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Estimé)

40

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

  • Nom: David Sanders, MD, FRCS(C) Principal Investigator
  • Numéro de téléphone: 519-685-8500
  • E-mail: david.sanders@lhsc.on.ca

Lieux d'étude

  • Canada
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre
        • Contact:
          • LHSCRI LHSCRI

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

  • Adulte
  • Adulte plus âgé

Accepte les volontaires sains

Non

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Soins de soutien
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: 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.
Comportemental: 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, power, and fatigue-resistance components. All sessions are supervised by study personnel, and no gym staff are involved in intervention delivery or data collection.
Aucune intervention: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Recruitment rate (participants enrolled per month)
Délai: Up to 6 months
Feasibility will be assessed by the number of participants enrolled per month during the recruitment period.
Up to 6 months
Adherence to supervised resistance training program (% of prescribed sessions completed)
Délai: Up to 6 months
Adherence will be calculated as the proportion of completed training sessions out of the total prescribed sessions.
Up to 6 months
Participant retention rate (% completing follow up assessments)
Délai: Up to 6 months
Retention will be defined as the proportion of participants who complete all scheduled follow-up assessments.
Up to 6 months

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Patient Specific Functional Scale Score
Délai: 12, 18, 24, and 52 weeks post-surgery
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.
12, 18, 24, and 52 weeks post-surgery
Health-related quality of life measured using SF-12
Délai: 12, 18, 24, and 52 weeks post-surgery
Health-related quality of life assessed using the 12-Item Short Form Health Survey (SF-12). Higher scores indicating better health status.
12, 18, 24, and 52 weeks post-surgery
Pain intensity measured using Numeric Pain Rating Scale (0-10)
Délai: 12, 18, 24, and 52 weeks post-surgery
Pain intensity measured using a numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain).
12, 18, 24, and 52 weeks post-surgery
Short Musculoskeletal Functional Assessment (SMFA) score
Délai: 12, 18, 24, and 52 weeks post-surgery
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.
12, 18, 24, and 52 weeks post-surgery
Functional Independence Test for Lower Extremity Injuries (FIX-IT) score
Délai: 12, 18, 24, and 52 weeks post-surgery
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.
12, 18, 24, and 52 weeks post-surgery
Lateral movement performance measured using Edgren Sidestep Test (seconds)
Délai: 12, 18, 24, and 52 weeks post-surgery
Lateral movement and agility assessed using the Edgren Sidestep Test. Performance is recorded as time to completion in seconds.
12, 18, 24, and 52 weeks post-surgery
Body weight (kilograms)
Délai: 12, 18, 24, and 52 weeks post-surgery
Body weight measured in kilograms using a calibrated scale.
12, 18, 24, and 52 weeks post-surgery
Body mass index (BMI, kg/m²)
Délai: 12, 18, 24, and 52 weeks post-surgery
Body mass index calculated as weight in kilograms divided by height in meters squared.
12, 18, 24, and 52 weeks post-surgery
Thigh circumference measured in centimeters
Délai: 12, 18, 24, and 52 weeks post-surgery
Thigh circumference measured in centimeters using a standardized tape measure to assess lower extremity muscle girth.
12, 18, 24, and 52 weeks post-surgery
Lower extremity muscle strength measured by exercise research team (force output)
Délai: 12, 18, 24, and 52 weeks post-surgery
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.
12, 18, 24, and 52 weeks post-surgery

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Estimé)

15 juin 2026

Achèvement primaire (Estimé)

15 juin 2030

Achèvement de l'étude (Estimé)

15 juin 2031

Dates d'inscription aux études

Première soumission

19 mai 2026

Première soumission répondant aux critères de contrôle qualité

1 juin 2026

Première publication (Réel)

5 juin 2026

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

5 juin 2026

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 juin 2026

Dernière vérification

1 mai 2026

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • RETRAIN Study
  • LHSCRI (Autre identifiant: LHSCRI)

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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