Effects Rehabilitation Programme in Adapted Physical Activity (APA) Among Type 2 Diabetics Persons
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 10
- 试验地点
- 8
- 主要终点
- Increase physical activity compliance long-term
研究概览
简要总结
The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.
详细描述
Clinical trial with direct individual profit. Study phase 2. Study center: University Hospital Grenoble Principal investigator: Pr. Serge HALIMI Sponsor: University Hospital Grenoble
The principal objective is to assess and analyze the effects of a six month programme in Adapted Physical Activity (APA) on physical activity, compliance, and insulin resistance among type 2 diabetics.
Secondary objectives are to assess and analyze the effects of a six month programme in APA of:
- arterial tension
- weight, body composition and abdominal perimeter
- quality of life
- treatment dosage
- number of hospitalisation thick a diabetes complication acute for one year and for each patient Compare two exercise's intensity: first lactate threshold (SL1) and crossover (PCGL).
Inclusion criteria:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 diabetics
- •Age > 40
- •First education in the Education Diabetics Department of the University Hospital Grenoble
- •Sedentary patients
- •Hemoglobin A1c (HbA1c) > 7%
- •Body mass index (BMI) > 25
- •To be affiliated with disease assurance
- •To give written and informed consent
排除标准
- •Foot sore < six months
- •Renal disease - proteinuria stage
- •Contraindication for exercise
- •VO2 max > 120% Wassermann standard
- •Coronary pathology non-stabilization
- •Arteriopathy stage 2 non-compensation
- •Osteo-articular crippling problem
- •Geographically distant
结局指标
主要结局
Increase physical activity compliance long-term
时间窗: 6 months after the beginning of the program
Modifiable Activity Questionnaire (MAQ
Lessen insulin resistance
时间窗: 6 months after the beginning of the program
HOMA (Homeo-stasis model assessment), HbA1c, PCGL
次要结局
- Improve the arterial tension(6 months after the beginning of the program)
- Lessen the weight(6 months after the beginning of the program)
- Improve the quality of life(6 months after the beginning of the program)