The Impact of Home Exercise Program Delivery Type on Exercise Compliance and Clinical Outcomes for Musculoskeletal Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 116
- 试验地点
- 2
- 主要终点
- Performance Assessment Tool
研究概览
简要总结
Patients seeking care for chronic low back or knee pain will be recruited for enrollment, and randomized within two phases (retention and compliance). Patients will consent to a 2-step study design, with independent randomization for each. The initial step will assess retention based on 4 different exercise prescription strategies. This will be assessed short-term, and then the 2nd step will consist of a second independent randomization to receive different reminder strategies to determine their influence on exercise compliance at home.
详细描述
Patients seeking care for their chronic low back or knee pain will be recruited to participate in a trial investigating the value of different exercise and education prescription strategies as well as strategies to determine the influence of various exercise reminder strategies. On day 1 of enrollment, patients will be randomized and instructed in two different types and amounts of exercises, as well as two types of delivery strategies. The ability to recall and perform these exercises will be assessed 20 minutes after completion of the instructional period (retention). In phase 2, patients will be randomized to receive different reminder strategies (none, email, text, and/or video) and their compliance assessed over a 1 month period (compliance). Self-reported compliance over the first month, and health care utilization outcomes will be analyzed for the 1 year following completion of the 1 month period, in all groups.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The primary complaint of low back pain or knee pain and is not actively seeking care for their contralateral knee.
- •The current episode for the injury is 6 weeks or greater
- •A home exercise program is appropriate as part of the management plan for their injury on the first day
- •Between the age of 18 and 65 years.
- •Own and utilize a smart phone
- •Read and speak English well enough to interact with the smart phone-based tool.
- •Able and willing to come in for follow-up at 1-month.
排除标准
- •History of prior surgery to the lower extremities or spine
- •Already receiving or have received treatment for this episode of pain within the past 6 months.
- •Medical "red flags" of a potentially serious condition including cauda equina syndrome, major or rapidly progressing neurological deficit, fracture, malignancy, joint infection, or systemic disease
- •If participating with low back pain, known current pregnancy or history of pregnancy in the last 6 months
- •Exiting military health system in the next 2 months, pending litigation, or pending a medical separation board.
结局指标
主要结局
Performance Assessment Tool
时间窗: 1-month
A locally developed tool designed to meet the needs of assessing both exercise retention and compliance. It will capture the subject's ability to recall the name of an exercise, the prescribed sets and repetitions, and the ability to perform an exercise using a 4-point ordinal scale
Compliance
时间窗: 1-month
Subjects will be asked to submit self-reported daily compliance logs.
次要结局
- Patient Reported Outcomes Measurement Information Systems (PROMIS) 57 (v2.0)(1-month)
- Self-perception on Physical Health and Ability to Return to Work or Full Duty(1-month)
- Patient Acceptable Symptom State (PASS)(1-month)
研究者
Dan Rhon
Researcher
Brooke Army Medical Center