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

NCT05274022 | Completed

• 2 other identifiers: 65286CDMRP-CDMRP-OR200133-A
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to evaluate speed high intensity interval training (HIIT) walking program following an orthopedic trauma.

Conditions

Femoral Fracture; Tibial Fractures

Keywords

Surgical fixation; High intensity interval training

Outcome Measures

Primary Outcomes (4)

• Self-reported physical function

  Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.

  Up to 12 weeks

• Self-reported physical function

  Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.

  Up to 19 weeks

• Self-reported physical function

  Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.

  6 months

• Self-reported physical function

  Patient Reported Outcomes Measurement Information System (PROMIS) Physical Function Questionnaire is a 53 question survey with a five point Likert scale ranging from 1 to 5 where a higher number indicates less physical function.

  12 months

Secondary Outcomes (32)

• 60-second step down test

  Up to 12 weeks

• 60-second step down test

  Up to 19 weeks

• 60-second step down test

  6 months.

• Usual Gait Speed

  Up to 12 weeks

• Usual Gait Speed

  Up to 19 weeks

Other Outcomes (3)

• Loading of the lower extremity

  Up to 12 weeks

• Loading of the lower extremity

  Up to 19 weeks

• Loading of the lower extremity

  6 months

Study Arms (2)

Standard of Care Physical Therapy Program

PLACEBO COMPARATOR

Standard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits.

Other: Standard of Care Physical Therapy Program

Standard of Care Physical Therapy Program with Speed Walking Intervention

EXPERIMENTAL

Standard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits. Additionally, subjects will complete the speed walking intervention. Participants will perform at 2 minute warm up followed by 1 minute of walking at their fastest tolerable speed followed by 2 minutes of active recovery where they will walk at a speed of their choosing. The subjects will perform 4 cycles of this followed by a 2 minute cool down at the end.

Other: Standard of Care Physical Therapy Program; Other: Speed Walking Intervention

Interventions

Speed Walking Intervention OTHER

The 4-6 week program will consist of a warm up of active stretching. Following the warm up, subjects will perform a 2 minute warm up followed by 1 minute of walking at their fastest comfortable speed followed by 2 minutes of active recovery where they will walk at a speed of their choosing for 4cycles and then a 2 minute cool down. The program will be performed 12 visits over 4-6 weeks.

Standard of Care Physical Therapy Program with Speed Walking Intervention

Standard of Care Physical Therapy Program OTHER

Standard of care will follow best practice. The subjects and their physical therapists will be provided with a standardized set of exercises and guidance on what to cover during skilled physical therapy visits. As part of the study, all patients will receive the same exercise program. Exercises will include lower extremity strengthening, balance, and mobility exercises with the use of modalities as needed

Standard of Care Physical Therapy Program; Standard of Care Physical Therapy Program with Speed Walking Intervention

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brian W. Noehren: lead
• U.S. Army Medical Research and Development Command: collaborator

Study Sites (2)

University of Kentucky

Lexington, Kentucky, 40506, United States

Location

Vanderbilt University

Nashville, Tennessee, 37203, United States

Location

MeSH Terms

Conditions

Femoral Fractures; Tibial Fractures

Condition Hierarchy (Ancestors)

Fractures, Bone; Wounds and Injuries; Leg Injuries

Study Officials

• Brian Noehren, Ph.D.

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 29, 2021
• First Posted: March 10, 2022
• Study Start: March 3, 2022
• Primary Completion: December 18, 2025
• Study Completion: December 18, 2025
• Last Updated: January 8, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)