Feasibility of Structured Resistance Training After Lower Extremity Fracture
1 giugno 2026 aggiornato da: 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.
Panoramica dello studio
Stato
Non ancora reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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 di studio
Interventistico
Iscrizione (Stimato)
40
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: David Sanders, MD, FRCS(C) Principal Investigator
- Numero di telefono: 519-685-8500
- Email: david.sanders@lhsc.on.ca
Luoghi di studio
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Ontario
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London, Ontario, Canada
- London Health Sciences Centre
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Contatto:
- LHSCRI LHSCRI
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Sperimentale: 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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Nessun intervento: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Recruitment rate (participants enrolled per month)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Patient Specific Functional Scale Score
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Stimato)
15 giugno 2026
Completamento primario (Stimato)
15 giugno 2030
Completamento dello studio (Stimato)
15 giugno 2031
Date di iscrizione allo studio
Primo inviato
19 maggio 2026
Primo inviato che soddisfa i criteri di controllo qualità
1 giugno 2026
Primo Inserito (Effettivo)
5 giugno 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
5 giugno 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
1 giugno 2026
Ultimo verificato
1 maggio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- RETRAIN Study
- LHSCRI (Altro identificatore: LHSCRI)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .