Lower Extremity Fractures
Conditions
Keywords
Femur Shaft fracture, Tibia Shaft Fracture, Postoperative Rehabilitation, Resistance Training, Lower extremity fracture
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.
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.
Interventions
BEHAVIORALStructured 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.
Sponsors
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Recruitment rate (participants enrolled per month) | Up to 6 months | 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) | Up to 6 months | Adherence will be calculated as the proportion of completed training sessions out of the total prescribed sessions. |
| Participant retention rate (% completing follow up assessments) | Up to 6 months | Retention will be defined as the proportion of participants who complete all scheduled follow-up assessments. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient Specific Functional Scale Score | 12, 18, 24, and 52 weeks post-surgery | 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 | 12, 18, 24, and 52 weeks post-surgery | 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) | 12, 18, 24, and 52 weeks post-surgery | Pain intensity measured using a numeric rating scale ranging from 0 (no pain) to 10 (worst possible pain). |
| Short Musculoskeletal Functional Assessment (SMFA) score | 12, 18, 24, and 52 weeks post-surgery | 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. |
| Functional Independence Test for Lower Extremity Injuries (FIX-IT) score | 12, 18, 24, and 52 weeks post-surgery | 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. |
| Lateral movement performance measured using Edgren Sidestep Test (seconds) | 12, 18, 24, and 52 weeks post-surgery | Lateral movement and agility assessed using the Edgren Sidestep Test. Performance is recorded as time to completion in seconds. |
| Body weight (kilograms) | 12, 18, 24, and 52 weeks post-surgery | Body weight measured in kilograms using a calibrated scale. |
| Body mass index (BMI, kg/m²) | 12, 18, 24, and 52 weeks post-surgery | Body mass index calculated as weight in kilograms divided by height in meters squared. |
| Thigh circumference measured in centimeters | 12, 18, 24, and 52 weeks post-surgery | Thigh circumference measured in centimeters using a standardized tape measure to assess lower extremity muscle girth. |
| Lower extremity muscle strength measured by exercise research team (force output) | 12, 18, 24, and 52 weeks post-surgery | 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. |
Countries
Canada
Contacts
CONTACTDavid Sanders, MD, FRCS(C) Principal Investigator
Outcome results
None listed