Clinical trial NCT05274022: Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture
Official title: Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Femoral Fracture
Tibial Fractures
Keywords: Surgical fixation
High intensity interval training
Lead sponsor: University of Kentucky
Sponsor class: OTHER
Collaborators: name: U.S. Army Medical Research and Development Command
First posted: 2022-03-10
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Self-reported physical function
timeFrame: Up to 12 weeks
measure: Self-reported physical function
timeFrame: Up to 19 weeks
measure: Self-reported physical function
timeFrame: 6 months
measure: Self-reported physical function
timeFrame: 12 months
Secondary outcomes:
measure: 60-second step down test
timeFrame: Up to 12 weeks
measure: 60-second step down test
timeFrame: Up to 19 weeks
measure: 60-second step down test
timeFrame: 6 months.
measure: Usual Gait Speed
timeFrame: Up to 12 weeks
measure: Usual Gait Speed
timeFrame: Up to 19 weeks
measure: Usual Gait Speed
timeFrame: 6 months
measure: Fastest Walking Speed
timeFrame: Up to 12 weeks
measure: Fastest Walking Speed
timeFrame: Up to 19 weeks
measure: Fastest Walking Speed
timeFrame: 6 months
measure: Six-minute walk Test:
timeFrame: Up to 12 weeks
measure: Six-minute walk Test:
timeFrame: Up to 19 weeks
measure: Six-minute walk Test:
timeFrame: 6 months
measure: Pain Assessment
timeFrame: Up to 12 weeks
measure: Pain Assessment
timeFrame: Up to 19 weeks
measure: Pain Assessment
timeFrame: 6 months
measure: Pain Assessment
timeFrame: 12 months
measure: Pain self-efficacy scale (PSEQ)
timeFrame: Up to 12 weeks
measure: Pain self-efficacy scale (PSEQ)
timeFrame: Up to 19 weeks
measure: Pain self-efficacy scale (PSEQ)
timeFrame: 6 months
measure: Pain self-efficacy scale (PSEQ)
timeFrame: 12 months
measure: Tampa scale of kinesiophobia (TSK)
timeFrame: Up to 12 weeks
measure: Tampa scale of kinesiophobia (TSK)
timeFrame: Up to 19 weeks
measure: Tampa scale of kinesiophobia (TSK)
timeFrame: 6 months
measure: Tampa scale of kinesiophobia (TSK)
timeFrame: 12 months
measure: Return to Work Status: Hours Worked
timeFrame: Up to 12 weeks
measure: Return to Work Status: Hours Worked
timeFrame: Up to 19 weeks
measure: Return to Work Status: Hours Worked
timeFrame: 6 months
measure: Return to Work Status: Hours Worked
timeFrame: 12 months
measure: Return to Work Status: Ability to Work
timeFrame: Up to 12 weeks
measure: Return to Work Status: Ability to Work
timeFrame: Up to 19 weeks
measure: Return to Work Status: Ability to Work
timeFrame: 6 months
measure: Return to Work Status: Ability to Work
timeFrame: 12 months
Other outcomes:
measure: Loading of the lower extremity
timeFrame: Up to 12 weeks
measure: Loading of the lower extremity
timeFrame: Up to 19 weeks
measure: Loading of the lower extremity
timeFrame: 6 months
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
city: Nashville
country: United States
facility: Vanderbilt University
state: Tennessee
Study officials:
affiliation: University of Kentucky
name: Brian Noehren, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: