Effects on Blood Pressure, Cardiorespiratory Condition and Cardiovascular Risk of Different Aerobic Exercise Programs With Nutritional Interventions in Hypertensive and Overweight People.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 176
- 试验地点
- 2
- 主要终点
- Blood pressure
研究概览
简要总结
Obesity and arterial hypertension (HTN) frequently coexist in the same patient. Moreover, the concept that obesity and HTN can be additive in terms of cardiovascular rist is widely accepted. Yet, clinical decision-making in obese patients is complicated by a surprising lack of evidence on the relative importance of obesity and HTN treatment and its efficacy and safety. Lifestyle interventions are the mainstay of obesity management programs and are also advocated in the prevention and treatment of HTN. Physical exercise and diet are recommended to prevent and control obesity and HTN. Aerobic exercise is firmly established as an effective measure for lowering blood pressure and reducing cardiovascular risk. However, there is no agreement about the optimal dose of frequency, intensity, duration and type of exercise. Therefore, the aims of the study are: 1) to assess the changes in selected parameters of blood pressure, cardiorespiratory fitness, body composition and biological markers brought about by a period of 16-week of different aerobic exercise programs with hypocaloric diet for overweight or obesity and primary hypertensive adults, and 2) to examine the effect of six months detraining subsequent to intervention. Secondary objectives are to examine the additional effect of the intervention on physical activity behavior and health-related quality of life.
详细描述
METHODOLOGY: participants will perform a ramp incremental cardiopulmonary exercise bike test before, after 16-week of follow-up, and after 6-month detraining period (with no intervention only recommendations). After inclusion criteria they will be randomized to four parallel groups: 1) control group with only hypocaloric diet intervention and lifestyle recommendations; 2) Moderate (HR values between VT1 and VT2 or 50-75% of HR reserve) continuous exercise and high volume (from 20 to 45min) group and hypocaloric diet intervention; 3) high intensity (HR values up to VT2 to peak intensity or ≥76% to <100 % of HR reserve) interval training and high-volume (from 20 to 45min) group alternating high and moderate intensities at different protocols and hypocaloric diet intervention; and 4) high-intensity interval training and low-volume (20min) group alternating high and moderate intensities at different protocolsand hypocaloric diet intervention.
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
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •older than 18yr old and less than 70yr old
- •overweight (BMI >25)
- •primary hypertension
- •low-moderate cardiovascular risk
- •not diet treatment
- •sedentary behavior
- •availability to exercise two days a week.
排除标准
- •secondary hypertension
- •pulmonary disorder
- •neurological deficit
- •physical incapacity to exercise
- •to exercise frequently
- •pregnancy or breastfeeding
- •left ventricular hypertrophy
- •more than three cardiovascular risk factors
结局指标
主要结局
Blood pressure
时间窗: 16-weeks
Ambulatory Blood Pressure Monitoring- 24 hours-Systolic and diastolic blood pressure
次要结局
- Physical activity and sedentary behavior(16-weeks)
- Peak Oxygen Uptake (VO2peak)(16-weeks)
- Health related Quality of life (QoL)(16-weeks)
- Ventilatory threshold (VT)(16-weeks)
- Biochemical variables(16-weeks)
- Incremental shuttle walk test (ISWT)(16-weeks)
- Anthropometry(16-weeks)
研究者
SARA MALDONADO-MARTIN
Dr. Sara Maldonado-Martin PhD
University of the Basque Country (UPV/EHU)