Feasibility of Structured Resistance Training After Lower Extremity Fracture

N/ANot Yet RecruitingNCT07629180

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's40 enrolled

Overview

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.

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

Allocation

NON_RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Lower Extremity Fractures

Interventions

Structured Supervised Resistance Training and Coaching ProgramBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 20 YearsMax age: 65 Years

Medical Language ↔ Plain English

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

Locations (1)

London Health Sciences Centre

London, Ontario, Canada

Outcomes

Primary Outcomes

Recruitment rate (participants enrolled per month)

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

Time frame: 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.

Time frame: 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.

Time frame: Up to 6 months

Secondary Outcomes

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.