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临床试验/NCT03452449
NCT03452449已完成不适用

Accelerometry-based Physical Activity, Disability and Quality of Life Before and After Lumbar Spine Surgery: a Prospective Study

University Hospital, Basel, Switzerland2 个研究点 分布在 1 个国家目标入组 29 人开始时间: 2017年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
29
试验地点
2
主要终点
Physical activity

研究概览

简要总结

To date it is unknown how physical activity levels in adults is limited before and after lumbar spine surgery and if physical activity level is associated with disability and limitations of quality of life. The main objective is to compare physical activity preoperatively and 6 and 12 weeks postoperatively in patients undergoing lumbar spine surgery with norm data. In addition, the investigators will study the association of changes in physical activity, disability and quality of live.

详细描述

Patients scheduled for planned lumbar spine surgery will be contacted to participate in this study. All outcomes will be assessed within 1 week preoperatively and at 6 and 12 weeks postoperatively. Changes in outcome scores will be detected using analysis of variance. Association of changes in physical activity and changes in secondary outcomes will be detected using stepwise linear regression models.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • primary lumbar spine surgery
  • single or multi level surgery on segments L2 to S1 (e.g. discectomy, decompression, laminectomy, foraminotomy)
  • German speaking

排除标准

  • stabilisation or fusion surgery or surgery above L2
  • previous lumbar spine surgery
  • indication: scoliosis, fracture, trauma, infection, tumor
  • limited walking ability due to other conditions
  • psychiatric conditions or dementia

结局指标

主要结局

Physical activity

时间窗: up to 12 weeks

measured using ActiGraph (accelerometer based activity monitor) as step counts, physical activity intensity during 7-day data capture period

次要结局

  • Disability(up to 12 weeks)
  • Quality of life assessed by questionnaire(up to 12 weeks)
  • Pain assessed by questionnaire(up to 12 weeks)

研究者

发起方
University Hospital, Basel, Switzerland
申办方类型
Other
责任方
Sponsor

研究点 (2)

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