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临床试验/NCT01377558
NCT01377558Unknown不适用

Effects of Different Types of Exercise Interventions in Patients With Type 2 Diabetes - Aerobic Endurance Training Versus Strength Endurance Training Versus Combined Aerobic Endurance and Strength Endurance Training -

University of Giessen2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2011年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
入组人数
100
试验地点
2
主要终点
Change in HbA1c-level (haemoglobin A1c)

研究概览

简要总结

The purposes of the study are

  • to determine which kind of supervised exercise intervention (aerobic endurance training versus strength endurance training versus combined aerobic endurance and strength endurance training) is more effective in improving the metabolic parameters in typ 2 diabetes patients
  • to investigate what kind of intervention is more successful in reduction of concomitant diseases and improving quality of life
  • to assess what kind of intervention induces highest effects in long term persistence of these positive changes

详细描述

Meta-analyses which evaluated the effects of structured exercise programs in patients with type 2 diabetes demonstrate that regular physical activity improves glycosylated haemoglobin (König et al.: Resistance Exercise and Type 2 Diabetes Mellitus, Deutsche Zeitschrift für Sportmedizin Jahrgang 62, Nr. 1 (2011): 5-9). Sigal et al. proved that either aerobic or resistance training alone improved glycemic control in type 2 diabetes, but the improvements are greatest with combined aerobic and resistance training (Sigal, RJ, et al.: Effects of Aerobic Training, Resistance Training, or Both on Glycemic Control in Type 2 Diabetes, Ann Intern Med. 2007 Sep 18;147(6):357-69).

Therefore, aim of the current study is to compare the effects of aerobic endurance training or resistance endurance training or the combination of aerobic endurance training and resistance endurance training in diabetes type 2 patients without any other lifestyle or dietary interventions.

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
Single (Investigator)

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

  • •diagnoses of type 2 diabetes (ADA criteria)
  • •admitted diabetes treatments will be diet and oral hypoglycemic agents

排除标准

  • •sports intervention >60 minutes per week
  • •medical conditions
  • •preproliferative or proliferative retinopathy
  • •instable coronary heart disease
  • •inability to perform the scheduled physical activity programs
  • •acute clinically significant intercurrent diseases

研究组 & 干预措施

Aerobic endurance training intervention

Experimental

Aerobic endurance training

干预措施: Aerobic endurance training intervention (Other)

Strength endurance training intervention

Experimental

Strength endurance training

干预措施: Strength endurance training intervention (Other)

Combined training intervention

Experimental

Combined aerobic endurance training and strength endurance training intervention

干预措施: Combined aerobic endurance and strength endurance training (Other)

Control group

No Intervention

control group

结局指标

主要结局

Change in HbA1c-level (haemoglobin A1c)

时间窗: 6 months

次要结局

  • Change in HOMA-Index(3 and 6 months)
  • Change in beta-cell-function(3 and 6 months)
  • Change in fasting plasma glucose levels(3 and 6 months)
  • Change in total cholesterol levels(3 and 6 months)
  • Change in HDL-cholesterol levels(3 and 6 months)
  • Change in LDL-cholesterol levels(3 and 6 months)
  • Change in triglyceride levels(3 and 6 months)
  • Change in antidiabetic medications(3 and 6 months)
  • Change in inflammation markers(3 and 6 months)
  • Change in body weight(3 and 6 months)
  • Change in body composition(3 and 6 months)
  • Change in strength(3 and 6 months)
  • Change of maximum heart rate(3 and 6 months)
  • Change of peak oxygen uptake(3 and 6 months)
  • Change of vAT (ventilatory anaerobic threshold)(3 and 6 months)
  • Change in blood pressure(3 and 6 months)
  • Change in renal function(3 and 6 months)
  • Change in concentration(3 and 6 months)
  • Change in quality of life(3 and 6 months)
  • Change of nutrition(3 and 6 months)
  • Change in voluntary physical activity(3 and 6 months)
  • Change of cardiac output by Impedance cardiography(3 and 6 months)
  • Change of barorezeptorsensitivity(3 and 6 months)
  • Change in carotid-Intima-Media-Thickness(3 and 6 months)
  • Change in aortic pulse-wave velocity(3 and 6 months)
  • Change in central aortic pressure(3 and 6 month)
  • Change in endothelial dysfunction(3 and 6 months)
  • Change of parodontitis(3 and 6 months)
  • Follow up of all parameters mentioned above(after 12 months)

研究者

申办方类型
Other

研究点 (2)

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