The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Change in Waist Circumference
研究概览
简要总结
This study will determine the health benefits of combining exercise training and increasing the amount of physical activity in daily life on the fat around the abdomen, weight, fitness and sensitivity to insulin. Volunteers will participate in one of three groups for 6 months: 1) a control group, 2) exercise training only, or 3) exercise training and increasing physical activity outside of training. The exercise training will follow the public health recommendations for exercise (150 minutes/week of moderate exercise). The group increasing physical activity along with exercise training will be asked to increase physical activity in their daily life (up to 3,000 step/day above their current levels through the use of step counters), and meetings focused on behavior modification. The investigators hypothesize that combining aerobic training and additional physical activity after training will have the most profound reduction on waist circumference and body composition.
详细描述
The Intervention Composed of Aerobic Training and Non-Exercise Physical Activity (I-CAN) study will investigate the effects of aerobic exercise training and increasing the amount of physical activity outside of training (Non-EX PA) on waist circumference, weight, and other cardiovascular disease risk factors in a prospective pilot trial. The investigators will randomize sedentary (<6,500 steps per day) obese adults with at least one additional cardiovascular risk factor (N= 45) to a: (1) structured aerobic exercise program with no intervention on Non-Ex PA (AERO group, N=15); (2) structured aerobic exercise program with the additional goal of increasing Non-EX PA (AERO-PA group, N=15), or (3) a non-exercise control group (CON, N=15) for 6 months. Exercise groups will participate in the same aerobic training program (50 to 75% VO2 max), designed to be consistent with public health recommendations of 150 minutes per week of moderate physical activity. Non-Ex PA in the AERO group will be tracked throughout the entire 6 month intervention with pedometers capable of counting steps, but not displaying them to the participant (blind mode capable). The AERO-PA group will progressively increase Non-Ex PA throughout intervention using pedometers (a progressive increase of 1,000 to 3,000 steps per day above baseline levels). The AERO-PA group will also participate in lifestyle counseling grounded in the principles of the behavioral change theories to determine/reinforce strategies to increase Non-Ex PA. The primary outcome measure will be change in waist circumference following the intervention. The results of this pilot study will be used to determine the efficacy/feasibility of the intervention, and power a larger trial as an R01 application.
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
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 40 to 65 years
- •Body mass index: 30-40
- •Sedentary status
- •One additional risk factor for cardiovascular disease
- •High waist circumference
排除标准
- •Previous heart attack or stroke
- •Type 1 or type 2 diabetes
- •Resting systolic blood pressure >180 mmHg
- •Resting diastolic blood pressure>100 mmHg
- •Plans to be away from the Pitt County area more than 4 weeks in the next 6 months
- •Currently pregnant or plans to become pregnant
- •Not full-filling requirements during the screening process
- •Currently using weight loss medications
- •Gastric banding surgery
研究组 & 干预措施
Control
The goal of this group is to maintain their current lifestyle habits during the intervention. participants are asked to make no conscious changes to their physical activity or dietary habits.
Aerobic Exercise Training
The Aerobic training group will participate in 6 months of aerobic training and asked to make no conscious alterations in their physical activity outside of exercise session, or dietary habits
干预措施: Aerobic Exercise Training (Behavioral)
Aerobic Exercise+ Physical Activity
The goal of this group is to perform 6 months of aerobic exercise and increase the amount of physical activity outside of their training sessions. They will be asked to make no conscious changes to their dietary habits
干预措施: Aerobic Exercise+ Physical Activity (Behavioral)
结局指标
主要结局
Change in Waist Circumference
时间窗: Baseline and 24 weeks
Waist circumference will be measured at the natural waist (midway between the inferior border of the rib cage and the superior aspect of the iliac crest) with a Gulick tape measure. Both landmarks (the inferior border of the ribcage and the superior aspect of the iliac crest) will be marked and the distance will be measured to determine the appropriate measurement site. Staff will confirm that: 1) the measurement tape remains horizontal; 2) the tape touches the entire circumference of the participant; 3) abdominal tissue is not compressed; 3) the tape measure is not within abdominal folds; 4) the measurement is taken at the end of normal respiration. The measurement will be repeated an additional time, and the reported value will be the average of these measurements. Both measurements must be within 0.5 cm to be considered acceptable for data purposes.
次要结局
- Change in Insulin(Baseline and 24 Weeks)
- Change in Body Fat(Baseline to 24 weeks)
- Change in Body Weight(Baseline and 24 weeks)
- Change in Cardiorespiratory Fitness (L/Min)(Baseline and 24 weeks)
- Change in Insulin Sensitivity(Baseline and 24 Weeks)
- Change in Low Density Lipoprotein (LDL)(Baseline and 24 weeks)
- Change in High Density Lipoprotein (HDL)(Baseline and 24 Weeks)
- Change in Total Cholesterol (mg/dL)(Baseline and 24 weeks)
- Change in Triglyceride Level(Baseline and 24 Weeks)
- Change in Glucose(Baseline and 24 weeks)
- Change in C-reactive Protein(Baseline and 24 weeks)
- Changes in Steps(Baseline and 24 Weeks)
- Change in Caloric Intake (Kilocalories)(Baseline and 24 weeks)
研究者
Damon Swift
Assistant Professor
East Carolina University