Does Exercise Consultation Have a Realistic Chance of Increasing the Physical Activity Level of Type 2 Diabetes Patients in Real Life?
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 4
- 主要终点
- Change in daily physical activity measured by SenseWear Pro3 Armband®. Participants were instructed to wear the monitor for seven days during all waking hours except bathing.
研究概览
简要总结
The prevalence of type 2 diabetes is high and expected to increase dramatically in worldwide, in France and especially in the French West Indies.This chronic disease is associated with premature mortality and various debilitating complications which can be prevented by optimal control of glycaemia, blood pressure and lipids. Diabetes management includes lifestyle modification and medication. Despite numerous studies supporting the benefits of frequent physical activity for people with Type 2 diabetes, an estimated 60±80% of this population remain sedentary. Promotion of physical activity in current diabetes care seems to be inadequate.
The aim of this randomized controlled trial is to evaluate the medium-term effectiveness (after 3 and 6months) of exercise consultation in promoting physical activity in outpatients with Type 2 diabetes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 DM diagnosed within 10 years prior the inclusion
- •18-70 years old
- •Signed written informed consent
- •Diabetes treatment regimens :
- •diet only
- •oral antidiabetic drug
- •oral antidiabetic drugs with long acting insulin analog
- •oral antidiabetic drugs with GLP 1 analog
排除标准
- •Patients with concurrent medical conditions preventing exercise
- •Pregnancy or intention to become pregnant during the study
- •Inability to read and write French
- •History of participating in our education program during the past two years
- •Usual sporty activities
- •Change in diabetes treatment during the three months prior to study enrollment
- •No written informed consent
结局指标
主要结局
Change in daily physical activity measured by SenseWear Pro3 Armband®. Participants were instructed to wear the monitor for seven days during all waking hours except bathing.
时间窗: 3 months
次要结局
- Benefits obtained after the physical activity counseling(6 months)