Evaluation of the Cognitive Function of Patients After Stem Cell Transplantation
试验速览
- 阶段
- 3 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- VO2max
研究概览
简要总结
The trial will evaluate the effects of an exercise program on the physical and cognitive performance of patients with hematological neoplastic diseases after high dose chemotherapy with stem cell support.
详细描述
Patients (n = 60) will be randomized to an exercise or a control group. The randomization will be stratified for allogeneic or autologous blood stem cell transplantation. Patients in the exercise group will carry out an endurance training consisting of walking on a treadmill at a speed corresponding to 80% of the maximum heart rate. The exercise program will be carried out 3 times weekly for 8 weeks. Patients in the control group will receive counseling about exercise and behavioural techniques to reduce fatigue, but they will not participate at a structured exercise program. Physical performance (VO2max), cognitive function, mood and quality of life will be evaluated at recruitment and after 8 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 70
- •Hematological neoplastic disease
- •Treatment with high-dose chemotherapy with peripheral blood stem cell transplantation in the previous 3 years
- •Karnofsky-Index > 80%
- •Ability to understand German
排除标准
- •Cardiorespiratory, metabolic, inflammatory or osteoarticular diseases which can be aggravated by exercise
- •Psychosis
- •Organic brain damage
- •PBSCT in the previous 6 weeks
- •Pathological stress test at admission
结局指标
主要结局
VO2max
时间窗: Recruitment and after 8 weeks
次要结局
- Cognitive status, mood, quality of life(At recruitment and after 8 weeks)