About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
Structured Supervised Resistance Training and Coaching Program
BehavioralA 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.
Treatment groups
Trial 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.
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.
Participant retention rate (% completing follow up assessments)
Retention will be defined as the proportion of participants who complete all scheduled follow-up assessments.
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.
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.
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).
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.
Sponsors and contacts
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