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临床试验/NCT04067167
NCT04067167Unknown不适用

Effects of Flexi Band Resistance Training Versus Different Electromyostimulation Exercise Programs in Patients With the Diagnosis of Malignant Diseases

University of Erlangen-Nürnberg Medical School2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2019年5月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100
试验地点
2
主要终点
Muscle strength

研究概览

简要总结

The purpose of this study is to investigate the effects of a 12-week flexi band resistance training program compared to different whole-body electromyostimulation (WB-EMS) exercise programs on muscle strength, body composition (in particular muscle mass), cardiorespiratory fitness, inflammation, and patient-reported subjective outcomes (e.g. quality of life, fatigue, performance status) 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

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

结局指标

主要结局

Muscle strength

时间窗: 12 weeks

Muscle strength of the five major muscle groups (chest, upper back, lower back, abdominals, legs) will be assessed by using specific strength-training devices and estimated using the one Repetition Maximum (1-RM, the maximum amount of weight \[kg\] that can be lifted for one repetition)

次要结局

  • Muscle Mass(12 weeks)
  • Fat Mass(12 weeks)
  • Total Body Water(12 weeks)
  • Cardiorespiratory Fitness (CRF)(12 weeks)
  • Inflammation status(12 weeks)
  • Patient-reported performance status-1(12 weeks)
  • Patient-reported performance status-2(12 weeks)
  • Patient-reported Quality of Life (QoL)(12 weeks)
  • Patient-reported Fatigue(12 weeks)
  • Patient-reported Physical Activity(12 weeks)
  • Objective Physical Activity(12 weeks)
  • Cardiometabolic Risk Profile (Metabolic Syndrome Z-Score, MetS)(12 weeks)

研究者

发起方
University of Erlangen-Nürnberg Medical School
申办方类型
Other
责任方
Sponsor

研究点 (2)

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