High Intensity Interval- vs Resistance or Combined- Training for Improving Cardiometabolic Health in Overweight Adults (Cardiometabolic HIIT-RT Study): Study Protocol for a Factorial Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
研究概览
简要总结
Several studies have shown relationship between exercise intensity and improvement cardiometabolic health such as body composition, endothelial function, blood pressure and blood lipids. It has been suggested that high intensity interval training and also strength or resistance training generate positive effects on metabolic risk factors, nevertheless the comparison between both types of training and their combination has not yet provided conclusive evidence. Also, it has been shown that dietary restriction has similar or more positive effects that exercise alone and the effect is greater when it is combined with exercise. For these reasons, it is necessary to clarify which type of training, in combination with a dietary restriction, is more effective to improve cardiometabolic health
详细描述
The investigators hypothesized that high intensity interval, resistance training or combined training would result in similar improvements in cardiometabolic health as compared to the usual clinical care in a cohort of sedentary overweight (age 30-50 years old).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Prevention
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 30 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Meets at least one criteria for metabolic Syndrome (IDF 2006): Central obesity: waist circumference ≥90cm (men) ≥80cm (women); triglycerides ≥ 150mg/dl; HDL-c <40mg/dl (men) <50 (women); Blood pressure ≥130/85mmHg and fasting plasma glucose ≥ 100mg/dL.
- •Written informed consent.
- •Interested in improving health and fitness.
排除标准
- •Systemic infections.
- •Weight loss or gain of >10% of body weight in the past 6 months for any reason.
- •Currently taking medication that suppresses or stimulates appetite.
- •Uncontrolled hypertension: systolic blood pressure 160 mm Hg or diastolic blood pressure 95 mm Hg on treatment.
- •Gastrointestinal disease, including self-reported chronic hepatitis or cirrhosis, any episode of alcoholic hepatitis or alcoholic pancreatitis within past year, inflammatory bowel disease requiring treatment in the past year, recent or significant abdominal surgery (e.g., gastrectomy).
- •Diagnosed diabetes (type 1 or 2), fasting impaired glucose tolerance (blood glucose 118 mg/dL), or use of any anti-diabetic medications.
- •Currently taking antidepressant, steroid, or thyroid medication, unless dosage is stable (no change for 6 months).
- •Any active use of illegal or illicit drugs.
- •Current exerciser (>30 min organized exercise per week).
- •Indication of unsuitability of current health for exercise protocol (PARQ).
- •Any other conditions which, in opinion of the investigators, would adversely affect the conduct of the trial.
研究组 & 干预措施
High Intensity Interval
Walking on a treadmill 4min at 80-90% peak heart rate and recovery 4 min at 65% peak heart rate until expenditure of 300 kcal during adaptation (first 4 weeks) and 500 kcal after week number 4 until the end of training.
干预措施: High Intensity Interval (Behavioral)
Resistance training
Completing a resistance circuit (including upper and lower muscle groups) as many times as needed according to subject weight until expenditure of 300 kcal during adaptation (first 4 weeks) at 20-30% of 1 one-rep max and 500 kcal after week number 4 until the end of training, at 40-60% of one-rep max.
干预措施: Resistance training (Behavioral)
Plus: High Intensity Interval + Resistance Training
Walking on a treadmill as intervention 1 until 50% the energy expenditure prescribed is reached, then completing a resistance circuit until 100% energy expenditure is reached. Exercise will be performed at three sessions per week.
干预措施: Plus: High Intensity Interval + Resistance Training (Behavioral)
Usual clinical care
This group will receive the usual clinical care according to the consensus recommendations of the national goals for cardiovascular health promotion and disease reduction of the American Heart Association and Colombian guidelines COLDEPORTES.
干预措施: Usual clinical care (Other)
结局指标
主要结局
Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
时间窗: Baseline and 12 weeks immediately after the interventions ends
FMD will be measured using the guidelines reported by Corretti et al. The diameter of the brachial artery will be assessed using a high-resolution ultrasound device (Siemens SG-60, USA), equipped with a 7.5 MHz linear array transducer.
次要结局
- Change from Baseline in muscular fitness(Baseline and 12 weeks immediately after the interventions ends)
- Change from Baseline in peak uptake of volume of oxygen(Baseline and 12 weeks immediately after the interventions ends)
- Change from Baseline in Triglycerides(Baseline and 12 weeks immediately after the interventions ends)
- Change from Baseline in Heart rate variability(Baseline and 12 weeks immediately after the interventions ends)
- Change from Baseline in body Composition as measured by Dual Energy X-ray Absorptiometry(Baseline and 12 weeks immediately after the interventions ends)
- Blood Pressure(Baseline and 12 weeks immediately after the interventions ends)
- Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version(Baseline and 12 weeks immediately after the interventions ends)
- Body Mass Index(Baseline and 12 weeks immediately after the interventions ends)
- Change from Baseline in LDL Cholesterol(Baseline and 12 weeks immediately after the interventions ends)
- Change from Baseline in HDL Cholesterol(Baseline and 12 weeks immediately after the interventions ends)
- Change from Baseline in Hemoglobin A1c(Baseline and 12 weeks immediately after the interventions ends)
- Body Weight(Baseline and 12 weeks immediately after the interventions ends)
- Change from Baseline in Flexibility using the sit and reach test(Baseline and 12 weeks immediately after the interventions ends)
- Change from Baseline in Glucose(Baseline and 12 weeks immediately after the interventions ends)
- 24-hour dietary recall(Baseline and 12 weeks immediately after the interventions ends)
- Aortic pulse wave velocity (PWVao) and augmentation index (AIx)(Baseline and 12 weeks immediately after the interventions ends)