Effects of a Protein-rich Individualized Nutritional Therapy Combined With Different Time-efficient Exercise Programs on Physical Fitness, Inflammation and Muscle Status in Cancer Patients Undergoing Curative or Palliative Anti-cancer Treatment
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Overall physical fitness
研究概览
简要总结
This study aims to evaluate the effects of a 12-week protein-rich individualized nutritional therapy combined with different time-efficient exercise programs on overall physical fitness (cardiorespiratory fitness and muscular fitness), inflammation, and muscle mass/body composition in patients with malignant disease undergoing curative or palliative anti-cancer treatment
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
- 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
- •malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma, lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation
- •ongoing or planned curative or palliative anti-cancer therapy
- •ECOG-Status 0-2
排除标准
- •simultaneous participation in other nutritional or exercise intervention Trials
- •bone metastases with high fracture risk
- •cardiovascular disease
- •use of anabolic medications
- •severe neurological or rheumatic diseases
- •skin lesions in the area of electrodes
- •energy active metals in body
- •pregnancy
- •acute vein thrombosis
研究组 & 干预措施
Resistance Training (RT)
Individualized, protein-rich nutritional therapy combined with resistance training
干预措施: Resistance Training (Other)
WB-EMS
Individualized, protein-rich nutritional therapy combined with whole-body electromyostimulation (WB-EMS)
干预措施: WB-EMS (Other)
High-intensity interval training (HIIT)
Individualized, protein-rich nutritional therapy combined with high-intensity interval training (HIIT)
干预措施: High-intensity interval training (HIIT) (Other)
Combined HIIT and Resistance Training (Combi)
Individualized, protein-rich nutritional therapy combined with a combined high-intensity interval training (HIIT) and resistance training
干预措施: Combined HIIT and Resistance Training (Combi) (Other)
结局指标
主要结局
Overall physical fitness
时间窗: 12 weeks
Cardiorespiratory Fitness and Muscular Fitness (Overall Fitness Score is calculated from Maximum Oxygen uptake, VO2max, and Muscle strength (estimated from the 1-repetition Maximum - the maximum amount of weight \[kg\] that can be lifted for one repetition) of the five major muscle groups (chest, upper back, lower back, abdominals, legs)
次要结局
- Patient-reported Quality of Life (QoL)(12 weeks)
- Patient-reported Fatigue(12 weeks)
- Patient-reported performance status-1(12 weeks)
- Patient-reported Physical Activity(12 weeks)
- Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)(12 weeks)
- Fat mass(12 weeks)
- Total Body Water(12 weeks)
- Patient-reported performance status-2(12 weeks)
- Objective Physical Activity(12 weeks)
- Inflammatory blood markers(12 weeks)
- Muscle mass(12 weeks)