Feasibility of Structured Resistance Training After Lower Extremity Fracture

NCT07629180 | Not Yet Recruiting

• 2 other identifiers: RETRAIN StudyLHSCRI
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lower Extremity Fractures

Keywords

Femur Shaft fracture; Tibia Shaft Fracture; Postoperative Rehabilitation; Resistance Training; Lower extremity fracture

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (10)

• Patient Specific Functional Scale Score

  12, 18, 24, and 52 weeks post-surgery

• Health-related quality of life measured using SF-12

  12, 18, 24, and 52 weeks post-surgery

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

  12, 18, 24, and 52 weeks post-surgery

• Short Musculoskeletal Functional Assessment (SMFA) score

  12, 18, 24, and 52 weeks post-surgery

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

  12, 18, 24, and 52 weeks post-surgery

Study Arms (2)

Structured Resistance Training Program

EXPERIMENTAL

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

Usual Care Control

NO INTERVENTION

Participants with surgically managed diaphyseal femur or tibia fractures who receive usual postoperative care without participation in the structured supervised exercise or coaching program.

Interventions

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.

Structured Resistance Training Program

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

London Health Sciences Centre

London, Ontario, Canada

Location

Central Study Contacts

David Sanders, MD, FRCS(C) Principal Investigator

CONTACT

519-685-8500; david.sanders@lhsc.on.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: June 5, 2026
• Study Start: June 15, 2026
• Primary Completion (Estimated): June 15, 2030
• Study Completion (Estimated): June 15, 2031
• Last Updated: June 5, 2026

Record last verified: 2026-05

Locations

CA (1)