Diabetes em Movimento® - Community-based Lifestyle Intervention Program for Patients With Type 2 Diabetes: Effects on Health and Well-being
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Cardiovascular Risk
研究概览
简要总结
Type 2 diabetes is a chronic disease that affects approximately 13% of Portuguese population and is associated with a high cardiovascular mortality by coronary artery disease and cerebrovascular disease and with a serious decline on well-being. Lifestyle changes are widely recommended to the control of type 2 diabetes and its complications. This study aims to analyse the effects of different community-based lifestyle programs (exercise or exercise plus dietary intervention) on health and well-being in patients 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with diagnosed type 2 diabetes at least for six months;
- •Both genders;
- •Aged between 50 and 80 years old;
- •Non-smokers;
- •Not engaged in supervised exercise;
- •Community-dwelling;
- •Medical recommendation for lifestyle intervention;
- •Known medical history;
- •Diabetes complications under medical control (poor metabolic control, diabetic foot, diabetic retinopathy, diabetic nephropathy and diabetic autonomic neuropathy;
- •No cardiovascular, respiratory and musculoskeletal contraindications to exercise;
- •No gait and balance problems;
- •Not taking insulin or sulfonylureas for less than three months;
- •Volunteer participation with signed informed consent.
排除标准
- •Participation in another supervised exercise program during the study;
- •Participation in another supervised dietary intervention during the study;
- •Aggravation of a diabetes complication or another major health problem;
研究组 & 干预措施
Exercise
Community-based exercise program
干预措施: Exercise (Behavioral)
Exercise plus dietary intervention
Community-based exercise and dietary intervention program
干预措施: Exercise (Behavioral)
Exercise plus dietary intervention
Community-based exercise and dietary intervention program
干预措施: Dietary intervention (Behavioral)
Control
Habitual physical activity and habitual dietary pattern
结局指标
主要结局
Cardiovascular Risk
时间窗: Baseline, 9 and 21 months
UKPDS Risk Engine
Health-Related Quality of Life
时间窗: Baseline, 9 and 21 months
SF-36 Health Survey
次要结局
- Physical Fitness(Baseline, 9 and 21 months)
- Dietary Pattern(Baseline, 9 and 21 months)
- Diabetic Foot Risk(Baseline, 9 and 21 months)
- Systolic Blood Pressure(Baseline, 9 and 21 months)
- Body Lean Mass(Baseline, 9 and 21 months)
- Symptoms of Anxiety and Depression(Baseline, 9 and 21 months)
- Waist Circumference(Baseline, 9 and 21 months)
- Falls Risk(Baseline, 9 and 21 months)
- Energy Expenditure(Baseline, 9 and 21 months)
- Food Literacy(Baseline, 9 and 21 months)
- Habitual Physical Activity(Baseline, 9 and 21 months)
- Exercise-Related Adverse Events(Baseline, 9 and 21 months)
- Diastolic Blood Pressure(Baseline, 9 and 21 months)
- Glycemic Control(Baseline, 9 and 21 months)
- Fast blood glucose(Baseline, 9 and 21 months)
- Total Cholesterol(Baseline, 9 and 21 months)
- Body Fat Mass(Baseline, 9 and 21 months)
- Chronic Pain(Baseline, 9 and 21 months)
- Diabetes-Dependent Quality of Life(Baseline, 9 and 21 months)
- Sitting-Time(Baseline, 9 and 21 months)
- Quality of Sleep(Baseline, 9 and 21 months)
- Body Mass Index(Baseline, 9 and 21 months)
研究者
Romeu Duarte Carneiro Mendes
MD, PhD
University of Trás-os-Montes and Alto Douro