Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures
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| ClinicalTrials.gov Identifier: NCT04612478 |
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Recruitment Status :
Active, not recruiting
First Posted : November 3, 2020
Last Update Posted : January 27, 2022
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Musculoskeletal Injury | Behavioral: Self-Directed Exercise Program Behavioral: Clinic-Based Physical | Not Applicable |
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
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| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 150 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Use of a Self-Directed Exercise Program (SDEP) Following Selected Lower Extremity Fractures |
| Actual Study Start Date : | March 14, 2018 |
| Estimated Primary Completion Date : | March 14, 2022 |
| Estimated Study Completion Date : | March 14, 2023 |
| Arm | Intervention/treatment |
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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.
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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. |
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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.
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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 |
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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.
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- 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)
- 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.
- 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
- Time to Radiographic Fracture Healing [ Time Frame: 3, 6 & 12 months ]Radiographs will be assessed for fracture healing.
- Muscle Strength [ Time Frame: 12 months ]Muscle strength will be measured using a dynamometer.
- Joint Range of Motion (ROM) [ Time Frame: 12 months ]Joint range of motion will be measured using a goniomenter.
- 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
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| Ages Eligible for Study: | 18 Years to 65 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04612478
| United States, North Carolina | |
| Carolinas Medical Center | |
| Charlotte, North Carolina, United States, 28203 | |
| United States, South Carolina | |
| Greenville Health System | |
| Greenville, South Carolina, United States, 29605 | |
| Principal Investigator: | Rachel Seymour, PhD | Atrium Health |
Documents provided by Rachel Seymour, Atrium Health:
| Responsible Party: | Rachel Seymour, Principal Investigator, Atrium Health |
| ClinicalTrials.gov Identifier: | NCT04612478 |
| Other Study ID Numbers: |
Pro00024283 |
| First Posted: | November 3, 2020 Key Record Dates |
| Last Update Posted: | January 27, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Undecided |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |