Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures

January 30, 2024 updated by: Wake Forest University Health Sciences
The purpose of this study is to compare the effectiveness and value of clinic-based physical therapy (PT) and a home-based, self-directed exercise program (SDEP). The home exercise program will be developed by a team of physical therapists, orthopaedic trauma surgeons and experts in rehabilitation engagement in collaboration with patients recovering from traumatic lower-extremity injuries. The study will also determine which subgroups of individuals based on patient and injury characteristics are the best candidates for a home exercise program.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

There is little clinical debate that patients with multiple extremity injuries or injuries with associated complex soft tissue damage or nerve deficits benefit from supervised PT. Prior research from the LEAP Study examined the impact of PT on patients with high energy trauma injuries below the distal femur.1 While the surgeons and PTs differed in their assessment of perceived need for PT,2,3 evidence demonstrates the beneficial effect of PT for this patient population.4 Research on combat-related lower extremity limb salvage patients showed a significant benefit and a higher return-to-duty rate following intense and focused rehabilitation combined with an integrated orthotic.5-7 However, the majority of lower extremity fractures seen in the military and civilian sectors are not combat related or of the severity of the Lower Extremity Assessment Project (LEAP) limb salvage patients and, thus may not require intensive, clinic-based, supervised PT treatment. Patients with isolated major lower extremity fractures may benefit from a self-guided, home-based post-injury exercise program. Studies evaluating home exercise programs for elective orthopaedic reconstruction surgery for joint replacement and anterior cruciate ligament (ACL )reconstruction have reported equivalent outcomes compared to in-person, supervised PT.8-12 Because PT resources are critical, limited, and expensive in most civilian centers, identifying the patients who would most benefit from utilizing these resources could result in savings for both the patients and the health care systems, and lead to more efficient access to PT services by the population who needs them the most. In addition to health systems benefits, patients able to achieve positive outcomes through a home-based, self-directed exercise program would experience flexibility regarding when the exercises are performed.

The purpose of this study is to compare the effectiveness and value of clinic-based PT and a home-based, self-directed exercise program (SDEP). The home exercise program will be developed by a team of physical therapists, orthopaedic trauma surgeons and experts in rehabilitation engagement in collaboration with patients recovering from traumatic lower-extremity injuries. The study will also determine which subgroups of individuals based on patient and injury characteristics are the best candidates for a home exercise program.

Hypothesis: The overall hypothesis is that return to work/major activities as well as clinical and functional outcomes and health-related quality of life for patients who receive clinic-based PT will be similar to patients receiving SDEP.

Specific Aim 1: To compare the effectiveness of SDEP, exercise instructions given by physician and clinic-based PT for improving return to work/major activities, clinical and functional/performance outcomes and health-related quality of life in patients following selected lower-extremity fractures.

Specific Aim 2: To determine which sub-groups of patients, based on patient and injury characteristics, are most likely to benefit from SDEP.

Specific Aim 3: To compare the cost-effectiveness of clinic-based PT and SDEP

.

Study Type

Interventional

Enrollment (Actual)

150

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28203
        • Carolinas Medical Center
    • South Carolina
      • Greenville, South Carolina, United States, 29605
        • Greenville Health System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-65 with operative fractures of the femur and tibia (to include distal femur (33A, B), plateau (41A, B), pilon (43A, B), and selected ankle injuries (44A, B)) presenting to the Orthopaedic Surgeon for either acute care or for the follow-up of care performed elsewhere (within 14 days of the injury).
  • All patients must be English or Spanish competent and able to be followed at the sites for at least 12 months following injury.

Exclusion Criteria:

  • Patients with Injury Severity Score (ISS)>18
  • Bilateral lower-extremity injuries that preclude crutch ambulation
  • Associated spine, pelvic, and/or acetabular fractures that otherwise alter weightbearing plan
  • Type III B/C open fractures
  • Glasgow Coma Scale <15 at time of discharge
  • Major peripheral nerve injury
  • Planned admission to a skilled nursing facility or inpatient rehabilitation facility
  • Pregnant women
  • Patients diagnosed with a Traumatic Brain Injury (TBI) will be excluded from the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Clinic-Based Physical Therapy
Patients will be referred to PT by the orthopaedic surgeon for enrollment into a clinic-based PT program per usual referral patterns at the surgeon's center. Patients will receive services based on their health care benefits defined by his or her insurance plan.
Behavioral: Clinic-Based Physical
Patients will be referred to PT by the orthopaedic surgeon for enrollment into a clinic-based PT program per usual referral patterns at the surgeon's center. Patients will receive services based on their health care benefits defined by his or her insurance plan.
Other: Self-Directed Exercise Program
The full SDEP program, which will be developed by physical therapists, orthopaedic trauma surgeons, and investigators with experience in health behavior change, will be designed to maximize adherence/compliance with the program. The SDEP manual will provide detailed instructions on exercises, such as repetitions, frequency, and required equipment, which can be implemented in the home environment. The basis for the exercise regimen is derived from the American Academy of Orthopaedic Surgeons (AAOS) sample home based exercise program available in handout form. The program provides instructions on exercises, repetitions or duration, frequency, and required equipment which can be implemented in the home environment.
Behavioral: Self-Directed Exercise Program
The full SDEP program, which will be developed by physical therapists, orthopaedic trauma surgeons, and investigators with experience in health behavior change, will be designed to maximize adherence/compliance with the program
No Intervention: Observational
Patients who are unwilling to be randomized will be enrolled in an observational arm of the study. They will be asked to complete all baseline and follow-up assessments, and participation in formal PT or SDEP will be documented.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Return to work/major activities
Time Frame: 12 months
Measured through the rate of return to work/duty 12 months post discharge using the Work Productivity and Activity Impairment Questionnaire (WPAI)
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: baseline, 3, 6 and12 months
The PROMIS-29 Profile v2.0 assesses depression, anxiety, physical function, pain interference, fatigue, sleep disturbance, and ability to participate in social roles and activities. Raw scores range from 4-20, with higher scores indicating lower quality of life in that area, except for the sleep disturbance sub-section, where higher scores indicate better sleep.
baseline, 3, 6 and12 months
Kinesiophobia
Time Frame: baseline, 3, 6 and12 months
As measured by Tampa Scale for Kinesiophobia (TSK). The TSK is a self-completed questionnaire and the range of scores are from 17 to 68 where the higher scores indicate an increasing degree of kinesiophobia
baseline, 3, 6 and12 months
Time to Radiographic Fracture Healing
Time Frame: 3, 6 & 12 months
Radiographs will be assessed for fracture healing.
3, 6 & 12 months
Muscle Strength
Time Frame: 12 months
Muscle strength will be measured using a dynamometer.
12 months
Joint Range of Motion (ROM)
Time Frame: 12 months
Joint range of motion will be measured using a goniomenter.
12 months
Resilience
Time Frame: Baseline, 3, 6 & 12 months
Resiliency will be measured using the Connor-Davidson Resilience Scale. Total Score of the resilience questions is 0 to 40, 10 subscales from 0 to 4 (summed up for total score), the higher the score the better the resilience
Baseline, 3, 6 & 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Rachel Seymour, PhD, Wake Forest University Health Sciences

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 14, 2018

Primary Completion (Actual)

November 2, 2022

Study Completion (Actual)

November 2, 2023

Study Registration Dates

First Submitted

May 7, 2018

First Submitted That Met QC Criteria

October 27, 2020

First Posted (Actual)

November 3, 2020

Study Record Updates

Last Update Posted (Actual)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IRB00082966
  • Pro00024283 (Other Identifier: Atrium)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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