Level of Activity in Lumbar Spinal Stenosis Patients Pre- and Post-surgery: a Non-randomized Controlled Before-after Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Activity Measure - Volume
研究概览
简要总结
The purpose of the proposed research is to explore the relationship between objectively measured physical activity and surgical intervention for lumbar spinal stenosis (LSS). Our primary hypothesis is that post-surgery, LSS patients will demonstrate increased physical activity compared to their baseline assessment. A non-intervention control group will be measured at the same time intervals as the surgical group to look at test re-test reliability. In the event that our hypothesis is rejected, and surgery does not lead to a decrease in sedentary behaviour analysis of questionnaire-based sedentary behaviour measures and objective activity-based measurement can examine the relationship between self-report and actual performance-based objective measures. The primary objective of our proposal is to determine if surgical intervention leads to increased activity, and decreased sedentary behaviour. The findings of the proposed research will inform healthcare stakeholders that if surgery alone does not lead to increased activity, a more concerted research effort may need to be made for post-surgical rehabilitation, lifestyle and physical activity counselling so that post-surgical patients may make changes toward leading more active and productive lives.
详细描述
Apparatus:
Activity Monitors: The ActiGraph GT3X+ monitor (ActiGraph, Pensacola, FL) has been shown to be reliable and to have good validity under both laboratory and free living conditions. It is one of the most widely respected monitors used for measuring physical activity and sedentary behaviour and is currently being used in an intervention trial with patients with LSS . The GT3X+ monitor includes a triaxial accelerometer, an inclinometer and light sensor. It is capable of measuring activity counts, steps, position relative to gravity and can discriminate between day and night. This accelerometer based sensor system does not impede normal movement and can be worn throughout the day on the waistband, in virtually all environments, except in water. The wGT3X+ activity monitor has the capacity to collect data at up to 100Hz.
Procedure:
Each participant will be given an ActiGraph wGT3X+ activity monitor with instructions to wear the monitor during waking hours over 7 consecutive days except when bathing, showering or swimming. Each ActiGraph monitor will be fastened to a belt over the anterior axillary line at the right hip as per the manufacturer's recommendations and initialized to collect data in 1s epochs. They will also be asked to complete log sheets recording the time they put the monitor on and take it off each day. Participants will complete 2 separate 7-day bouts, six weeks apart.
For the surgical group the ActiGraph will be used in the week leading up to their surgical intervention. The follow-up will occur 6-weeks post surgery. For the no intervention group the ActiGraph will be used in the week immediately after it is determined they are a surgical candidate, and the follow-up will occur 6-weeks later while they are on the surgical waitlist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Confirmed clinical diagnosis of lumbar spinal stenosis through diagnostic imaging and clinical testing/history from a spine surgeon
- •Considered pre-surgical but in need of surgery (surgical necessity also confirmed by a spine surgeon)
排除标准
- •Not in immediate surgical need
- •No diagnosis of degenerative lumbar spinal stenosis.
结局指标
主要结局
Activity Measure - Volume
时间窗: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
Daily physical activity data collected by the ActiGraph wGT3X+ activity monitor will be analyzed and described using volume (e.g., activity counts/day).
Activity Measure - Rate
时间窗: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
Daily physical activity data collected by the ActiGraph wGT3X+ activity monitor will be analyzed and described using rate (e.g., average steps/minute/day).
Activity Measure - Time Indicators
时间窗: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
Daily physical activity data collected by the ActiGraph wGT3X+ activity monitor will be analyzed and described using time indicators (e.g., time spent in sedentary, light, moderate and high intensity physical activity categories/day) using standard cut-point thresholds.
Activity Measure - Maximum Continuous Daily Activity
时间窗: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
The maximum number of consecutive minutes at or above 100 activity counts/min (a threshold thought to represent low intensity activity) with no more than 1 min of activity below this low intensity threshold will be determined along with the average duration of activity bouts/day.
Activity Measure - Sedentary Bout Length
时间窗: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
Collected by ActiGraph wGT3X+ activity monitor
Activity Measure - Maximum Bout Length
时间窗: Change from Baseline Activity Measures at 6 weeks (post-surgery or post non-intervention)
Collected by ActiGraph wGT3X+ activity monitor
Self-Report Measures - Swiss Spinal Stenosis Scale
时间窗: Change between responses collected at baseline, and 6 weeks later for both groups.
Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.
Self-Report Measures - Quadruple Numeric Rating Scale (QNRS)
时间窗: Change between responses collected at baseline, and 6 weeks later for both groups.
Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.
Self-Report Measures - Fear Avoidance Belief Questionnaire (FABQ)
时间窗: Change between responses collected at baseline, and 6 weeks later for both groups.
Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.
Self-Report Measures - Sedentary Behaviors Questionnaire (SBQ)
时间窗: Change between responses collected at baseline, and 6 weeks later for both groups.
Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.
Self-Report Measures - Short Form Health Survey (SF-36)
时间窗: Change between responses collected at baseline, and 6 weeks later for both groups.
Questionnaire based outcome measures will be used to subjectively quantify baseline differences between all participants in the Surgery or NI groups.
次要结局
未报告次要终点
研究者
Dr. Steven Passmore
Steven Passmore, DC, PhD
University of Manitoba