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临床试验/NCT01136096
NCT01136096已完成不适用

Effects of Exercise Behavior Modification on Plasma Adiponectin and Insulin Resistance in High Risk Subjects of Diabetes

National Taiwan University Hospital1 个研究点 分布在 1 个国家目标入组 216 人开始时间: 2004年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
216
试验地点
1
主要终点
Plasma adiponectin level in μg/ml

研究概览

简要总结

Investigators hypothesized home-based exercise intervention was beneficial to those who have had diabetic risk factor for type 2 diabetes mellitus

详细描述

This randomized clinical trial was designed to investigate whether a home-based exercise could improve adiponectin levels, exercise behavior and metabolic risk factors (insulin resistance, metabolic components and physical fitness) in subjects with at least a diabetic risk factor for type 2 diabetes mellitus. Participants were randomly allocated to either a control group or a home-based exercise group. All participants were evaluated for outcome measures at baseline, and at 3-month 6-month and 9-month follow-up after engaging in the intervention.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
20 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •At least one of the following criteria as following: BMI >=24 kg/m*m, hypertension, dyslipidemia, fist-degree relatives of parents with type 2 diabetes, impaired glucose tolerance, gestational diabetes and delivering a babt weighing >=4.0 kg
  • •Ability of understanding Chinese or Taiwanese

排除标准

  • •Receiving treatment with insulin or oral hypoglycemic agents
  • •Any other serious illness that prohibit them to undertake fitness evaluation

研究组 & 干预措施

Lifestyle counseling

Experimental

To promote participants' exercise behaviors with individualized home-based exercise program was designed based on the Health Belief Model and Transtheoretical Model

干预措施: Physical activity promoting intervention (Behavioral)

Control

Other

Received oral instruction and written general education information without individualized exercise program

干预措施: General instruction and education (Behavioral)

结局指标

主要结局

Plasma adiponectin level in μg/ml

时间窗: Nine months after the start of the intervention

Fasting blood samples were centrifuged to obtain plasma and then immediately stored at -20℃. Plasma adiponectin levels were then determined through enzyme-linked immunoassay (ELISA).

Exercise behavior

时间窗: Nine months after the start of the intervention

1. Exercise self-efficacy: Measured by exercise self-efficacy questionnaire in score 2. Physical activity: Meausred by 7-day recall questionnaire in kcal/kg/day

次要结局

  • Insulin resistance(Three, 6 and 9 months after the start of the intervention)
  • Metabolic components(Three, 6 and 9 months after the start of the intervention)
  • Physical fitness(Three, 6 and 9 months after the start of the intervention)
  • Dietary intake(Three, 6 and 9 months after the start of the intervention)
  • Plasma adiponectin level in μg/ml(Three and 6 months after the start of the intervention)
  • Exercise behavior(Three and 6 months after the start of the intervention)

研究者

申办方类型
Other

研究点 (1)

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