NCT01289587已完成不适用
Efficacy and Feasibility of a Program to Promote Physical Activity in Patients With Type 2 Diabetes (DIAfit)
University of Lausanne Hospitals2 个研究点 分布在 1 个国家目标入组 185 人开始时间: 2011年2月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 185
- 试验地点
- 2
- 主要终点
- Aerobic fitness
研究概览
简要总结
The aim of this study is to evaluate the effects of a physical activity intervention in patients with type 2 diabetes in a community setting.
详细描述
The aim of this study is
- to evaluate the effects (before and after) of a physical activity program (DIAfit program) which contains 36 sessions of structured PA and also encourages unstructured PA in an unselected population of patients with type 2 diabetes independent of the selected variant of the program
- to compare the effects of a standard DIAfit program (3 times per week for 12 weeks) with and alternative program which suggests a more progressive PA activity intensity (starting with one PA session per week during 4 weeks and then twice a week over a period of 16 more weeks (20 weeks total). In total the program also consist of 36 sessions)
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
- Double (Investigator, Outcomes Assessor)
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
- •Diagnosis of type 2 diabetes
排除标准
- •Orthopedic complications
- •Diabetic foot ulceration
- •"Active " cardiac (ischemia during the exercise test) or stade III peripheral vascular disease
- •Untreated proliferative retinopathy
- •Autonomic neuropathy
- •Active psychiatric, neurological, orthopedic, muscular or rheumatic disease interfering with a participation in a physical activity program
- •Pregnancy
结局指标
主要结局
Aerobic fitness
时间窗: End of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment)
Change in aerobic fitness
次要结局
- Body composition(At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment))
- Lipid values(At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment))
- Qualitative evaluation (satisfaction of achievement of personal objectives, evaluation of group session)(At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment))
- Adherence/Attendance: Number of physical activity sessions attended(During the intervention)
- Self-efficacy(At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment))
- HbA1c(At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment))
- Physical activity(At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment))
- Motor performance(At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment))
- BMI(At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment))
- Well-being(At the end of the intervention (36 PA sessions, 12 vs 20 weeks depending on assignment))
研究者
Jardena Puder
MD
University of Lausanne Hospitals
研究点 (2)
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