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Search / Trial NCT05274022

Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture

Launched by BRIAN W. NOEHREN · Mar 1, 2022

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Surgical Fixation High Intensity Interval Training

ClinConnect Summary

This clinical trial is looking at a specific type of exercise program called high-intensity interval training (HIIT) to see if it can help people recover better after having surgery for a fracture in their leg, specifically in the femur or tibia. The study aims to understand how this walking program can improve recovery outcomes for patients who have experienced these kinds of injuries.

To participate in the trial, individuals need to be between 18 and 50 years old and able to read and speak English. They must have recently had surgery for a fracture in their femur or tibia that required a special type of fixation. However, people with certain conditions, like chronic pain, severe brain injuries, or those who are pregnant, cannot join. Participants can expect to engage in the HIIT walking program and attend follow-up visits to monitor their progress. Overall, this study seeks to find effective rehabilitation strategies for those recovering from serious leg injuries.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Ability to read and speak English
  • Acute orthopedic injury to the femoral or tibial shaft requiring surgical fixation with an intramedullary rod
  • Age 18-50 years of age
  • Exclusion Criteria:
  • History of chronic pain defined as pain lasting more than 3 months and bothersome at least half the days over the past 6 months that started before the fracture
  • Moderate or severe traumatic brain injury
  • Initial treatment requiring amputation
  • Not employed at the time of the accident at least 20 hours per week.
  • Spinal cord injury
  • History of schizophrenia, dementia or neurologic disorder with peripheral dysfunction
  • Non ambulatory or limited ability to walk without an assistive device prior to the fracture
  • Multiple trauma that prevents early weight bearing
  • Current Pregnancy
  • Unable to participate in or complete in-person follow-up visits or therapy sessions
  • In outpatient Physical Therapy at the start of the intervention
  • Use of an assistive device to walk for community ambulation at the 10-12 weeks post hospital discharge time point

About Brian W. Noehren

Brian W. Noehren is a distinguished clinical trial sponsor with a focus on advancing innovative therapeutic solutions through rigorous research and development. With a strong background in clinical science and a commitment to ethical standards, Noehren leads initiatives that prioritize patient safety and efficacy. His efforts are directed towards enhancing understanding in various medical fields, fostering collaboration among multidisciplinary teams, and ensuring that clinical trials are conducted with the highest integrity. Through his leadership, he aims to contribute significantly to the body of knowledge in healthcare and improve patient outcomes.

Locations

Lexington, Kentucky, United States

Nashville, Tennessee, United States

Patients applied

0 patients applied

Trial Officials

Brian Noehren, Ph.D.

Principal Investigator

University of Kentucky

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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