Feasibility of Structured Resistance Training After Lower Extremity Fracture

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age20-65
SponsorLondon Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 2 treatment groups
Group A: Structured Resistance Training ProgramExperimental treatment 1 intervention
Group B: Usual Care ControlNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

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
2

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
3

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

1

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.

Time frame
12, 18, 24, and 52 weeks post-surgery
2

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.

Time frame
12, 18, 24, and 52 weeks post-surgery
3

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).

Time frame
12, 18, 24, and 52 weeks post-surgery
4

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.

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

Other outcomes

Sponsors and contacts

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