Active Commuting To Improve Well-being and Health in Everyday Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 188
- 试验地点
- 2
- 主要终点
- Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
研究概览
简要总结
The aim of present randomized controlled trial is to evaluate the health effects of physical activity in transport and leisure time domains of everyday life and to develop durable physical activity regimens, i.e. to go from lifestyle intervention to daily lifestyle routine, in overweight individuals.
Subjects will be randomized to 1 of 4 groups. 1: Vigorous intensity leisure time physical activity, 2: Moderate intensity leisure time activity, 3: Active commuting by bicycle, or 4: a non-intervention control group
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •No engagement in habitual structured physical activity
- •Body mass index 25-35 kg/m2
- •Body fat percentage >32% for women and >25% for men
- •Maximum oxygen uptake (VO2max) <40 ml O2/kg/min for women and <45 ml O2/kg/min for men
- •Ethnicity: Caucasian
排除标准
- •Chronic use of medicine
- •Fasting plasma glucose > 6,1 mmol/L
- •Blood pressure > 140/90 mm Hg
- •Abnormal resting and working ECG
- •Parents or siblings with diagnosed type 2 diabetes
- •For women: Follicle stimulating hormone (FSH) concentration > 35 milliunits/ml, pregnancy or planning of pregnancy within the coming year
研究组 & 干预措施
Control
Receives no intervention.
Vigorous intensity LTPA
Leisure time physical activity (LTPA): Exercise intensity: 70% of maximal oxygen uptake (VO2 max); Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
干预措施: Physical activity (Behavioral)
Moderate intensity LTPA
Leisure time physical activity (LTPA): Exercise intensity: 50% VO2 max; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week
干预措施: Physical activity (Behavioral)
Active commuting
Bicycling to/from work/school/university. No requirements for exercise intensity; Energy expenditure: Females: 1600 kcal/week; Males: 2100 kcal/week; Avg distance per day Females 9-15 km; Males 11-17 km
干预措施: Physical activity (Behavioral)
结局指标
主要结局
Peripheral insulin sensitivity (glucose clearance ml/min/kg fat-free mass/nM insulin)
时间窗: Change from baseline in peripheral insulin sensitivity at 6 months
Measured using the hyper-insulinemic euglycaemic clamp
Haemostatic balance
时间窗: Change from baseline in endogenous thrombin potential at 6 months
Blood coagulation measured by fasting levels of endogenous thrombin potential (nM x min)
次要结局
- Glycaemic control(Baseline, 3 and 6 months)
- Abdominal fat mass(Baseline, 3 and 6 months)
- Health related quality of life and other psycho-social outcomes(Baseline, 3 and 6 months)
- Anthropometry(Baseline, 3 and 6 months)
- Sleep habits(Baseline, 3 and 6 months)
- Subcutaneous adipose tissue biopsy(Baseline, 3 and 6 months)
- Haemostatic balance II(Baseline, 3 and 6 months)
- Metabolic syndrome(Baseline, 3 and 6 months)
- Central insulin sensitivity(Baseline, 3 and 6 months)
- Maximal oxygen uptake (ml/O2/kg/min)(Baseline, 3 and 6 months)
- Skeletal muscle biopsy(Baseline, 3 and 6 months)
研究者
Bente Merete Stallknecht
Professor
University of Copenhagen