Feasibility of Structured Resistance Training After Lower Extremity Fracture
1. juni 2026 opdateret af: 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.
Studieoversigt
Status
Ikke rekrutterer endnu
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
40
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: David Sanders, MD, FRCS(C) Principal Investigator
- Telefonnummer: 519-685-8500
- E-mail: david.sanders@lhsc.on.ca
Studiesteder
-
-
Ontario
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London, Ontario, Canada
- London Health Sciences Centre
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Kontakt:
- LHSCRI LHSCRI
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-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
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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Ingen indgriben: 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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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Recruitment rate (participants enrolled per month)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Patient Specific Functional Scale Score
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 12, 18, 24, and 52 weeks post-surgery
|
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
Tidsramme: 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)
Tidsramme: 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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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
15. juni 2026
Primær færdiggørelse (Anslået)
15. juni 2030
Studieafslutning (Anslået)
15. juni 2031
Datoer for studieregistrering
Først indsendt
19. maj 2026
Først indsendt, der opfyldte QC-kriterier
1. juni 2026
Først opslået (Faktiske)
5. juni 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
5. juni 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
1. juni 2026
Sidst verificeret
1. maj 2026
Mere information
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Nøgleord
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- LHSCRI (Anden identifikator: LHSCRI)
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