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| ID | Type | Description | Link |
|---|---|---|---|
| LHSCRI | Other Identifier | LHSCRI |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12, 18, 24, and 52 weeks post-surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| David Sanders, MD, FRCS(C) Principal Investigator | Contact | 519-685-8500 | david.sanders@lhsc.on.ca |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| London Health Sciences Centre | London | Ontario | Canada |
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| 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. |
| 12, 18, 24, and 52 weeks post-surgery |
| 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). | 12, 18, 24, and 52 weeks post-surgery |
| 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. | 12, 18, 24, and 52 weeks post-surgery |
| Functional Independence Test for Lower Extremity Injuries (FIX-IT) score | 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. | 12, 18, 24, and 52 weeks post-surgery |
| Lateral movement performance measured using Edgren Sidestep Test (seconds) | Lateral movement and agility assessed using the Edgren Sidestep Test. Performance is recorded as time to completion in seconds. | 12, 18, 24, and 52 weeks post-surgery |
| Body weight (kilograms) | Body weight measured in kilograms using a calibrated scale. | 12, 18, 24, and 52 weeks post-surgery |
| Body mass index (BMI, kg/m²) | Body mass index calculated as weight in kilograms divided by height in meters squared. | 12, 18, 24, and 52 weeks post-surgery |
| Thigh circumference measured in centimeters | Thigh circumference measured in centimeters using a standardized tape measure to assess lower extremity muscle girth. | 12, 18, 24, and 52 weeks post-surgery |
| Lower extremity muscle strength measured by exercise research team (force output) | 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. | 12, 18, 24, and 52 weeks post-surgery |