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Not yet recruiting NCT07629180

Feasibility of Structured Resistance Training After Lower Extremity Fracture

No phase Interventional Lower Extremity Fractures

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Structured Supervised Resistance Training and Coaching Program.
Who it may be relevant to
Registry conditions: Lower Extremity Fractures. Basic parameters: 20 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Canada
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Feasibility and Impact of a Structured, Supervised Exercise Program Following Lower Extremity Fracture: A Pilot Controlled Study

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.

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

  • Behavioral Structured 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, po

Primary outcome measures

  • Recruitment rate (participants enrolled per month) [Time frame: Up to 6 months]
  • Adherence to supervised resistance training program (% of prescribed sessions completed) [Time frame: Up to 6 months]
  • Participant retention rate (% completing follow up assessments) [Time frame: Up to 6 months]
Secondary outcome measures (10)
  • Patient Specific Functional Scale Score [Time frame: 12, 18, 24, and 52 weeks post-surgery]
  • Health-related quality of life measured using SF-12 [Time frame: 12, 18, 24, and 52 weeks post-surgery]
  • Pain intensity measured using Numeric Pain Rating Scale (0-10) [Time frame: 12, 18, 24, and 52 weeks post-surgery]
  • Short Musculoskeletal Functional Assessment (SMFA) score [Time frame: 12, 18, 24, and 52 weeks post-surgery]
  • Functional Independence Test for Lower Extremity Injuries (FIX-IT) score [Time frame: 12, 18, 24, and 52 weeks post-surgery]
  • Lateral movement performance measured using Edgren Sidestep Test (seconds) [Time frame: 12, 18, 24, and 52 weeks post-surgery]
  • Body weight (kilograms) [Time frame: 12, 18, 24, and 52 weeks post-surgery]
  • Body mass index (BMI, kg/m²) [Time frame: 12, 18, 24, and 52 weeks post-surgery]
  • Thigh circumference measured in centimeters [Time frame: 12, 18, 24, and 52 weeks post-surgery]
  • Lower extremity muscle strength measured by exercise research team (force output) [Time frame: 12, 18, 24, and 52 weeks post-surgery]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Supportive care

Study locations

Canada · 1 center
  • London Health Sciences Centre — London

Identifiers

NCT: NCT07629180 · RETRAIN Study · LHSCRI

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗