Rehabilitation Strategies to Improve Outcomes For Patients With a Lower Extremity Fracture
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 2
- 主要终点
- Self-reported physical function
研究概览
简要总结
The purpose of this study is to evaluate speed high intensity interval training (HIIT) walking program following an orthopedic trauma.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Standard of Care Physical Therapy Program (Other)
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.
干预措施: Standard of Care Physical Therapy Program (Other)
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.
干预措施: Speed Walking Intervention (Other)
结局指标
主要结局
Self-reported physical function
时间窗: 12 months
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.
Self-reported physical function
时间窗: Up to 12 weeks
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.
Self-reported physical function
时间窗: Up to 19 weeks
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.
Self-reported physical function
时间窗: 6 months
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.
次要结局
- Usual Gait Speed(6 months)
- Fastest Walking Speed(6 months)
- Six-minute walk Test:(6 months)
- Pain self-efficacy scale (PSEQ)(12 months)
- Return to Work Status: Ability to Work(12 months)
- Tampa scale of kinesiophobia (TSK)(12 months)
- 60-second step down test(6 months.)
- Return to Work Status: Hours Worked(12 months)
- Pain Assessment(12 months)
- 60-second step down test(Up to 12 weeks)
- 60-second step down test(Up to 19 weeks)
- Usual Gait Speed(Up to 12 weeks)
- Usual Gait Speed(Up to 19 weeks)
- Fastest Walking Speed(Up to 12 weeks)
- Fastest Walking Speed(Up to 19 weeks)
- Six-minute walk Test:(Up to 12 weeks)
- Six-minute walk Test:(Up to 19 weeks)
- Pain Assessment(Up to 12 weeks)
- Pain Assessment(Up to 19 weeks)
- Pain Assessment(6 months)
- Pain self-efficacy scale (PSEQ)(Up to 12 weeks)
- Pain self-efficacy scale (PSEQ)(Up to 19 weeks)
- Pain self-efficacy scale (PSEQ)(6 months)
- Tampa scale of kinesiophobia (TSK)(Up to 12 weeks)
- Tampa scale of kinesiophobia (TSK)(Up to 19 weeks)
- Tampa scale of kinesiophobia (TSK)(6 months)
- Return to Work Status: Hours Worked(Up to 12 weeks)
- Return to Work Status: Hours Worked(Up to 19 weeks)
- Return to Work Status: Hours Worked(6 months)
- Return to Work Status: Ability to Work(Up to 12 weeks)
- Return to Work Status: Ability to Work(Up to 19 weeks)
- Return to Work Status: Ability to Work(6 months)
研究者
Brian W. Noehren
Professor
University of Kentucky