Telehealth Physical Activity Intervention After Lumbar Spine Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Mean daily post-operative physical activity as measured by an accelerometer.
研究概览
简要总结
The overall objective of this randomized controlled study is to examine the preliminary efficacy of a physical activity intervention that includes wearable technology and remote physical therapist support in patients undergoing lumbar spine surgery. Patients will be randomized to receive 8 sessions of a telehealth physical activity intervention (n=30) or usual postoperative care (n=30). The Investigator's central hypothesis is that a postoperative telehealth physical activity intervention will lead to greater improvements in objective physical activity (primary outcome) and patient-reported physical function, disability, and pain (secondary outcomes) compared to usual care in patients undergoing lumbar spine surgery.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults age 18 years or older
- •Scheduled for surgical treatment of a lumbar degenerative condition using laminectomy with or without arthrodesis procedures
- •English speaking
排除标准
- •Patients having microsurgical techniques as the primary procedure, such as an isolated laminotomy or microdiscectomy
- •Patients having surgery for spinal deformity as the primary indication
- •Patients having revision surgery
- •Patients having surgery for pseudarthrosis, trauma, infection, or tumor
- •Presence of back and/or lower extremity pain < 3 months
- •History of neurological disorder, resulting in moderate to severe movement dysfunction
- •Unable to provide stable address and access to internet and smartphone or tablet/iPad/computer/laptop indicating the inability to participate in the intervention
结局指标
主要结局
Mean daily post-operative physical activity as measured by an accelerometer.
时间窗: Baseline to 12 months post-surgery
Post-operative physical activity will be calculated as the average steps/day over a period of 7 days as measured by accelerometer
次要结局
- Leg pain as measured by the Numeric Rating Scale (NRS).(Baseline to 12 months post-surgery)
- Post-operative physical activity as measured by an accelerometer.(Baseline to 12 months post-surgery)
- Physical function as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Physical Function Domain(Baseline to 12 months post-surgery)
- Back pain as measured by the Numeric Rating Scale (NRS).(Baseline to 12 months post-surgery)
- Disability as measured by the Oswestry Disability Index.(Baseline to 12 months post-surgery)
- Opioid Use as measured by patient self-report.(Baseline to 12 months post-surgery)
- Depression as measured by the Patient Reported Outcomes Measurement Information System (PROMIS) - Depression Domain(Baseline to 12 months post-surgery)
- Pain self-efficacy as measured by the Pain Self-Efficacy Questionnaire (PSEQ)(Baseline to 12 months post-surgery)
- Fear of movement as measured by theTampa Scale of Kinesiophobia.(Baseline to 12 months post-surgery)
研究者
Kristin Archer
Professor, Department of Orthopaedics & Rehab
Vanderbilt University Medical Center