Physical Exercise to Improve Physical Performance and Health Related Quality of Life in Hematopoietic Stem Cell Transplantation Recipients
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 8
- 主要终点
- Musculoskeletal performance
研究概览
简要总结
The proposed study in an inception cohort of patients with hematological malignancies treated with PBSCT is designed to evaluate the effects of a physical exercise intervention on muscular-skeletal, physical activity and quality of life outcomes.
详细描述
Peripheral Stem Cell Transplantation is a frequently used therapy option to increase survival in hematological and lymphatic malignancies. These malignancies and their treatment are associated with numerous physical and psychological symptoms and severe side effects. Physical exercise has been proposed as a promising strategy for the treatment of some of these physical and psychological complaints, and various exercise interventions are currently available after cancer treatment. To date, promising preliminary results concerning exercise programs in PBSCT recipients were published with limited sample size populations. Results of musculoskeletal outcomes in PBSCT recipients after cancer treatment are lacking.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
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
- •Status after high-dose chemotherapy following Hematopoietic Stem Cell Transplantation
- •Willing to enter a physical exercise program
- •Good understanding of the German language
- •Written informed consent
排除标准
- •Uncontrolled cardiovascular disease and myocardial infarction in the previous six months
- •Uncontrolled hypertension
- •Uncontrolled thyroid disease
- •Uncontrolled diabetes
- •Diagnosis of depression before entering the study.
结局指标
主要结局
Musculoskeletal performance
时间窗: Baseline -3 months - 6 months
Knee extension strength
时间窗: Baseline -3 months - 6 months
Grip Strength
时间窗: Baseline -3 months - 6 months
6 minute walk test
时间窗: Baseline -3 months - 6 months
15-meter walking speed
时间窗: Baseline -3 months - 6 months
and Health Related Quality of Life: (Physical function subscale of the EORTC-QLQ-C30 questionnaire).
时间窗: Baseline -3 months - 6 months
次要结局
- Role-,cognitive-,emotional-,social-,symptom scales and the global health and quality of life scale of the EORTC-QLQ-C30 Health Related Quality of Life questionnaire.(Baseline -3 months - 6 months)
- Self-reported fatigue(Baseline -3 months - 6 months)
- Self-reported and objectively assessed physical activity(Baseline -3 months - 6 months)
- Whole body composition(Baseline -3 months - 6 months)
- Haemotological values: e.g Hemoglobin(Baseline -3 months - 6 months)