Investigation of an Exercise Intervention for Multiple Myeloma Patients With Stable and Unstable Osteolytic Lesions During Induction Therapy.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Fatigue (MFI, Multidimensional Fatigue Inventory)
研究概览
简要总结
Physical exercise is an important supportive therapy for cancer patients, which improves quality of life and can effectively counteract the side effects of drug therapy. There is very little experience whether physical activity can also be performed safely by patients with malignant diseases that affect bone stability. This applies in particular to patients with multiple myeloma, a disease characterized by a monoclonal proliferation of plasma cells in the bone marrow and often accompanied by severe bony destruction. Aim of this exploratory randomized controlled trial is to evaluate feasibility, safety and effectivity of an orthopaedic-guided exercise intervention during induction therapy in newly diagnosed multiple myeloma patients.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •newly diagnosed multiple myeloma
- •Survival prognosis > 6 months
- •ECOG status ≤ 3
- •Age ≥18 years
- •Patients who state that they want to carry out the training program at least 2 x/week and participate in the planned follow-up visits
- •Ability to give informed consent
- •Written consent to participate in the study
- •Sufficient knowledge of written and spoken German
排除标准
- •physical or mental limitation that would prevent participation in the training program or the planned follow-up visits.
- •Carrying out a regular, intensive training program (min. 1h, 2x/week)
结局指标
主要结局
Fatigue (MFI, Multidimensional Fatigue Inventory)
时间窗: From enrollment to the end of stem cell transplantation (approximately one year)
次要结局
未报告次要终点
研究者
Ulrike Dapunt
Prof. Dr. med.
University Hospital Heidelberg