Feasibility of Structured Resistance Training After Lower Extremity Fracture

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Lower Extremity Fractures
• Intervention / Treatment: Behavioral: Structured Supervised Resistance Training and Coaching Program

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: David Sanders, MD, FRCS(C) Principal Investigator; Phone Number: 519-685-8500; Email: david.sanders@lhsc.on.ca

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rate (participants enrolled per month)	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)	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)	Retention will be defined as the proportion of participants who complete all scheduled follow-up assessments.	Up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Specific Functional Scale Score	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	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)	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	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	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)	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)	Body weight measured in kilograms using a calibrated scale.	12, 18, 24, and 52 weeks post-surgery
Body mass index (BMI, kg/m²)	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	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)	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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Estimated): June 15, 2026
• Primary Completion (Estimated): June 15, 2030
• Study Completion (Estimated): June 15, 2031

Study Registration Dates

• First Submitted: May 19, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Resistance Training; Postoperative Rehabilitation; Lower extremity fracture; Femur Shaft fracture; Tibia Shaft Fracture
• Other Study ID Numbers: RETRAIN Study; LHSCRI (Other Identifier: LHSCRI)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No