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

NCT ID: NCT05274022

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-03
• Study Completion Date: 2025-12-18

Brief Summary

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

Detailed Description

In HIIT an individual gives short bursts of high effort followed by a longer recovery period.

Increasingly, HIIT style training programs have been used in other clinical populations (heart conditions, kidney failure, severely obese) to yield improved health outcomes and have been shown to be safe and effective. However, this work has not been extended to the orthopedic trauma population. Initiating a treadmill HIIT program during recovery from a lower extremity fracture may prove pivotal to restoring functional abilities, improving strength, and optimizing patient outcomes.

As a starting point to investigate the speed HIIT walking program following an orthopedic trauma, the investigators will focus on femoral and tibial shaft fractures requiring surgical fixation. Subjects will be recruited at a follow-up visit and therefore will not have impaired consent capacity issues at that juncture based on their fracture-related injuries. Even though early postoperative weight bearing has been shown to be safe, there continues to be considerable divergence in recovery after these fractures. For instance, return to work rates for individuals with physical jobs has been reported to be as low as 14% within the first year, resulting in significant stress and financial challenges for the individual. Clearly, improved post-operative rehabilitation strategies are needed for this population.

Aim 1: Assess the feasibility and adherence of the speed HIIT walk program within subjects with a lower extremity fracture.

Primary Hypothesis: 70% of subjects approached about the study will consent and that 80% of subjects will complete the study.

Secondary hypothesis: 80% of subjects will complete all of the treatment sessions and find the treatment (both intervention and standard of care physical therapy) acceptable.

Aim 2: Determine the preliminary effects of the speed HIIT program as compared to the standard of care on patient reported outcomes, functional outcomes and return to work rates, in a pilot randomized control trial.

Primary Hypotheses: Participants in the speed HIIT intervention group will have a significantly higher PROMIS physical function scale as compared to standard of care group at a 6 month follow up.

Secondary hypotheses: Participants in the Speed HIIT intervention group will have higher return to work rates, usual and fastest gait speed, timed step-down test, and 6-minute walk test than the standard of care group at a 6 month follow up.

Tertiary hypothesis: The participants in the speed HIIT program will maintain higher physical function and return to work rates at a 12 month follow up as compared to the standard of care group

Aim 3: Quantify the differences in ground reaction forces, function, psychosocial responses, and patient reported outcomes that occur at the completion of the speed HIIT walk program as compared to the group receiving standard of care physical therapy.

Primary Hypotheses: Participants in the speed HIIT program will be significantly more symmetric in their peak ground reaction force metrics (impulse, loading rates, time, peak values), and have greater self reported physical function, functional outcomes and patient reported outcomes as compared to the standard of care group at the completion of the intervention (19 weeks post hospital discharge).

Secondary hypotheses: Participants completing the speed HIIT program will have greater pain self-efficacy and less fear of movement as compared to the standard of care at the completion of the intervention (19 weeks post hospital discharge) that is maintained at a 6 and 12 month follow up.

Tertiary hypothesis: The participants in the speed HIIT program will maintain higher symmetry in their peak ground reaction force metrics (impulse, loading rates, time, peak values) as compared to the standard of care group at a 6 month follow up.

Conditions

Femoral Fracture; Tibial Fractures

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Standard of Care Physical Therapy Program

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.

Group Type: PLACEBO_COMPARATOR

Standard of Care Physical Therapy Program

Intervention Type: 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 with Speed Walking Intervention

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.

Group Type: EXPERIMENTAL

Standard of Care Physical Therapy Program

Intervention Type: 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

Speed Walking Intervention

Intervention Type: 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.

Interventions

Standard of Care Physical Therapy Program

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

Intervention Type: OTHER

Speed Walking Intervention

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

U.S. Army Medical Research and Development Command

FED

Sponsor Role: collaborator

Brian W. Noehren

OTHER

Sponsor Role: lead

Responsible Party

Brian W. Noehren

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Brian Noehren, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Kentucky

Locations

University of Kentucky

Lexington, Kentucky, United States

Vanderbilt University

Nashville, Tennessee, United States

Countries

United States

Provided Documents

Document Type: Informed Consent Form

View Document

Other Identifiers

CDMRP-CDMRP-OR200133-A

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

65286

Identifier Type: -

Identifier Source: org_study_id