Glioblastoma and Sports - Does a Personal Training Program Improve Physical Performance and Quality of Life of Brain Tumor Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- Increase in Physical Performance according to Physical Work Capacity (PWC) Test
研究概览
简要总结
The aim of the present study is the prospective controlled use of physical activity in a collective of patients with glioblastoma after surgery and concomitant radiation/chemotherapy and during adjuvant cytotoxic therapy. The research question is whether physical exercise is feasible and whether patients benefit physically and mentally from the activities performed. For this purpose, specific training units under the supervision of a certified trainer and sports scientist as well as standardized sports medical test procedures are implemented. Beyond the instructed training, general physical activity phases are recorded electronically using a pedometer/activity tracker, which is worn at all times.
It will be examined whether the individual training program
- improves physical fitness
- increases quality of life/life satisfaction throughout the intervention
- can be detected in blood due to increased concentrations of brain-derived neurotrophic factor 1 (BDNF-1) (voluntary)
The measurements should be taken before and 8, 16 and 24 weeks after the start of training.
详细描述
The personal trainers of the university clinics in Bochum and Homburg/Saar receive specific training activities from Münster's trainer Ralf Brandt in order to ensure a standardized concept. This way, a comparison of the trainings' conduction and recording is possible both quantitatively and qualitatively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Newly diagnosed glioblastoma
- •Karnofsky Index ≥ 70
- •Eastern Cooperative Oncology Group (ECOG) ≤ 2
- •≥ 18 years
- •Completed surgical therapy
- •Completed radiation and chemotherapy
- •Thrombocytes > 50.000/µl
- •Hb > 8 mg/dl
- •Ability to give consent
- •Mother tongue German/very good German skills
排除标准
- •Diagnosed dementia (Mini-Mental-State-Test < 24/30 points)
- •Pain (strong, permanent, restricting movement)
- •Impairment of consciousness
- •Acute infection
- •Pregnancy and lactation
- •Insufficiently adjusted epilepsy (despite anticonvulsive therapy > 3 focal seizures per day or > 1 generalized seizure in the previous 3 days)
结局指标
主要结局
Increase in Physical Performance according to Physical Work Capacity (PWC) Test
时间窗: Between week 0 and 16.
Evidence of a significant increase (at least 15%) in physical work \[watt/kilogram bodyweight\] at PWC75% of maximum heart rate.
次要结局
- Physical Work Capacity (PWC)(Between week 0 and 16 (and 24).)
- PWC(after 8, 16 and 24 weeks)
- Spiroergometry - lactate(Between week 0 and 16 (and 24).)
- Spiroergometry - maximal oxygen consumption (VO2max)(Between week 0 and 16 (and 24).)
- EORTC-QLQ-C30 Brain module(Between week 0 and 16 (and 24).)
- Distress Thermometer (DT)(Between week 0 and 16 (and 24).)
- Hospital Anxiety and Depression Scale (HADS)(Between week 0 and 16 (and 24).)