NCT01374399已完成不适用
Effects of an One-year Physical Exercise Intervention on Prognosis, Side-effects and Complications After Allogeneic Stem Cell Transplantation
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 267
- 试验地点
- 1
- 主要终点
- Overall survival
研究概览
简要总结
The PETRA-Study is a randomized, controlled trial and designed to examine the effects of an one-year physical exercise intervention on prognosis, side-effects and complications after allogeneic stem cell transplantation.
The exercise intervention includes both, resistance and endurance training. Patients assigned to the control group perform a relaxation program (progressive muscle relaxation - Jacobsen) and have the same frequency of social contact.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Medical indication: allogeneic stem cell transplantation
排除标准
- •Orthopeadic limitations that hamper the exercise intervention
- •Osseous degenerations that have an improved fracture risk
研究组 & 干预措施
resistance and endurance exercise
Experimental
干预措施: exercise and relaxation (Behavioral)
relaxation
Active Comparator
干预措施: exercise and relaxation (Behavioral)
结局指标
主要结局
Overall survival
时间窗: two years
次要结局
- Adherence to exercise protocol(one year)
- Fatigue(admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation)
- Quality of Life(admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation)
- Hemoglobin, Leukocytes, Thrombocytes(during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation)
- Side-effects (Infections, GvHD, Depression, Distress)(during hospitalisation for allo-HSCT (expected average 4-5 weeks), day 100, day 180, day 270, day 365 post transplantation)
- Muscular strength(admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation)
- cardiorespiratory fitness(admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation)
- IL-6, IL-4, IL-8, IL-10, IL-1ra, TNF-alpha, Prostaglandin(admission to hospital for allo-HSCT, discharge from hospital (expected average of 4 to 5 weeks after admission), day 100, day 180, day 270 and day 365 post transplanation)
- median survival, non-relapse mortality(admission to hospital until 2 years after transplantation)
研究者
研究点 (1)
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