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Feasibility of Structured Resistance Training After Lower Extremity Fracture

L

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Status

Not yet enrolling

Conditions

Lower Extremity Fractures

Treatments

Behavioral: Structured Supervised Resistance Training and Coaching Program

Study type

Interventional

Funder types

Other

Identifiers

NCT07629180
RETRAIN Study
LHSCRI (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment

40 estimated patients

Sex

All

Ages

20 to 65 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Structured Resistance Training Program
Experimental group
Description:
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.
Treatment:
Behavioral: Structured Supervised Resistance Training and Coaching Program
Usual Care Control
No Intervention group
Description:
Participants with surgically managed diaphyseal femur or tibia fractures who receive usual postoperative care without participation in the structured supervised exercise or coaching program.

Trial contacts and locations

1

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Central trial contact

David Sanders, MD, FRCS(C) Principal Investigator

Data sourced from clinicaltrials.gov

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