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Feasibility of Structured Resistance Training After Lower Extremity Fracture

1. juni 2026 oppdatert av: 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.

Studieoversikt

Status

Har ikke rekruttert ennå

Forhold

Intervensjon / Behandling

Detaljert 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.

Studietype

Intervensjonell

Registrering (Antatt)

40

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

  • Canada
    • Ontario
      • London, Ontario, Canada
        • London Health Sciences Centre
        • Ta kontakt med:
          • LHSCRI LHSCRI

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

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

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Støttende omsorg
  • Tildeling: Ikke-randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Atferdsmessig: 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.
Ingen inngripen: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Recruitment rate (participants enrolled per month)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Up to 6 months
Retention will be defined as the proportion of participants who complete all scheduled follow-up assessments.
Up to 6 months

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Patient Specific Functional Scale Score
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

15. juni 2026

Primær fullføring (Antatt)

15. juni 2030

Studiet fullført (Antatt)

15. juni 2031

Datoer for studieregistrering

Først innsendt

19. mai 2026

Først innsendt som oppfylte QC-kriteriene

1. juni 2026

Først lagt ut (Faktiske)

5. juni 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

5. juni 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

1. juni 2026

Sist bekreftet

1. mai 2026

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Andre studie-ID-numre

  • RETRAIN Study
  • LHSCRI (Annen identifikator: LHSCRI)

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

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