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NCT Number: NCT07629180

Feasibility of Structured Resistance Training After Lower Extremity Fracture

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.

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Key information

Conditions

Lower Extremity Fractures

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

London Health Sciences Centre

London, Ontario, Canada

Location contact

LHSCRI LHSCRI

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Structured Supervised Resistance Training and Coaching Program

Behavioral

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.

Primary outcomes

  1. Recruitment rate (participants enrolled per month)

    Time frame: Up to 6 months

    Feasibility will be assessed by the number of participants enrolled per month during the recruitment period.

  2. Adherence to supervised resistance training program (% of prescribed sessions completed)

    Time frame: Up to 6 months

    Adherence will be calculated as the proportion of completed training sessions out of the total prescribed sessions.

  3. Participant retention rate (% completing follow up assessments)

    Time frame: Up to 6 months

    Retention will be defined as the proportion of participants who complete all scheduled follow-up assessments.

Secondary outcomes

  1. Patient Specific Functional Scale Score

    Time frame: 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.

  2. Health-related quality of life measured using SF-12

    Time frame: 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.

  3. Pain intensity measured using Numeric Pain Rating Scale (0-10)

    Time frame: 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).

  4. Short Musculoskeletal Functional Assessment (SMFA) score

    Time frame: 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.

  5. Functional Independence Test for Lower Extremity Injuries (FIX-IT) score

    Time frame: 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.

  6. Lateral movement performance measured using Edgren Sidestep Test (seconds)

    Time frame: 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.

  7. Body weight (kilograms)

    Time frame: 12, 18, 24, and 52 weeks post-surgery

    Body weight measured in kilograms using a calibrated scale.

  8. Body mass index (BMI, kg/m²)

    Time frame: 12, 18, 24, and 52 weeks post-surgery

    Body mass index calculated as weight in kilograms divided by height in meters squared.

  9. Thigh circumference measured in centimeters

    Time frame: 12, 18, 24, and 52 weeks post-surgery

    Thigh circumference measured in centimeters using a standardized tape measure to assess lower extremity muscle girth.

  10. Lower extremity muscle strength measured by exercise research team (force output)

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David Sanders, MD, FRCS(C) Principal Investigator

CONTACT

[email protected]

519-685-8500

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

Feasibility and Impact of a Structured, Supervised Exercise Program Following Lower Extremity Fracture: A Pilot Controlled Study

Important dates

Study start
2026
Primary completion
2030
Study completion
2031
First posted
Jun 5, 2026
Registry last updated
Jun 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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