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临床试验/NCT00834015
NCT00834015已完成不适用

Outcome of Lumbar Spinal Fusion Patients and Significance of Postoperative Exercise Therapy: Randomized Controlled Trial and Spine Register Study

Jyväskylä Central Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2010年5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
100
试验地点
2
主要终点
pain

研究概览

简要总结

The aim of the present study is to analyse the significance of postoperative combined strength and aerobic training for outcome of the lumbar fusion patients compared to usual care (patients with isthmic or degenerative spondylolisthesis).

详细描述

Most of the studies published so far about lumbar fusion surgery have been interested in surgical procedure itself or in comparison of conservative or operative treatment. Less information is available about long-term outcome and exercise programs for operated patients. Therefore the investigators have developed "Spine fusion register", which include data on surgery procedure and outcome (pain, disability, back muscle function, quality of life, working capacity, reoperations and complications etc.) before and after surgery up to 5 years (started in January 1st, 2008). The main purpose of the present study is to analyze the significance of 12-month strength and aerobic training for outcome of the lumbar fusion patients compared to usual care. Patients (N=100) with lumbar fusion because of isthmic or degenerative olisthesis will be will be stratified by catchments area and randomized into combined strength and aerobic training group or into the control group.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Single (Outcomes Assessor)

入排标准

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

入选标准

  • over 20 years old
  • isthmic or degenerative spondylolisthesis

排除标准

  • cardiovascular or musculoskeletal diseases, which may exclude their ability to perform strength and endurance training and testing
  • metabolic bone disease
  • psychosocial instability
  • malignant disease

结局指标

主要结局

pain

时间窗: baseline, 1 year (+ 1 year follow-up)

visual analogue scale (VAS)

disability

时间窗: baseline, 1 year (+ 1 year follow-up)

quality of life

时间窗: baseline, 1 year (+ 1 year follow-up)

次要结局

  • spine mobility(baseline, 1 year)
  • fear of movement(baseline, 1 year postoperatively)
  • depressive symptoms(baseline, 1 year)
  • trunk muscle strength(baseline, 1 year)
  • physical activity(baseline, 1 year)

研究者

发起方
Jyväskylä Central Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Arja Häkkinen

Professor

Jyväskylä Central Hospital

研究点 (2)

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