Outcome of Lumbar Spinal Fusion Patients and Significance of Postoperative Exercise Therapy: Randomized Controlled Trial and Spine Register Study
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
- 否
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
Arja Häkkinen
Professor
Jyväskylä Central Hospital
