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临床试验/NCT03236285
NCT03236285撤回不适用

Microvascular and Metabolic Effects of High-intensity Interval Training (HIIT) and Intermittent Fasting (FAST) in Overweight or Obese, Sedentary Women With Cardiometabolic Risk Factors: HIIT-FAST, a Randomized Clinical Trial

National Institute of Cardiology, Laranjeiras, Brazil2 个研究点 分布在 1 个国家开始时间: 2018年2月20日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
2
主要终点
Capillary density

研究概览

简要总结

The study investigates the effects of high intensity interval training (HIIT) versus continuous training (CT), combined or not with fasting, on capillary density, microvascular function, cardiometabolic risk markers, functional capacity, and quality of life, in overweight or obese sedentary women with cardiometabolic risk factors. The use of HIIT could promote greater improvements in these parameters than CT. Furthermore, the positive effects of exercise may increase when it is performed in the fasting state, compared to exercise performed in the fed state.

详细描述

Physical inactivity and increased caloric intake play important roles in the pathophysiology of obesity. Increases of physical activity and modifications of eating behaviors are first-line interventions which, however, are not easily implemented, and lack of time to exercise and difficulties in coping with different diets are common reasons for failure. High-intensity interval training (HIIT) is a "faster" alternative to moderate-intensity continuous training (CT). Conversely, intermittent fasting is also an alternative to more complex diets, as it restricts caloric intake to a specified period of time without major diet composition changes. The combination of HIIT and fasting may therefore provide incremental benefits.

Sedentary women aged ≥ 30 years and ≤50 years, with body mass index ≥25 kg/m2 and cardiometabolic risk factors, will be randomized to HIIT performed in the fasting state, HIIT performed in the fed state, CT in the fasting state or CT in the fed state. Cardiometabolic parameters, anthropometric indices, cardiorespiratory fitness, quality of life and microvascular function (cutaneous capillary density and microvascular reactivity evaluated by laser speckle contrast imaging) will be evaluated before the initiation of the interventions and 4 weeks thereafter.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
30 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Female gender
  • Age≥ 30 years and ≤50 years
  • Premenopausal status
  • Body mass index >25 kg/m2
  • At least one of the following:
  • waist circumference ≥80 cm (women); triglycerides ≥150 mg/dl or treatment for this lipid abnormality; High density-lipoprotein cholesterol <50 mg/dl (women), or treatment for this abnormality; fasting plasma glucose ≥100 mg/dl

排除标准

  • Any cardiovascular disease, including systemic hypertension
  • Diabetes mellitus
  • Chronic pulmonary disease
  • Any systemic disease or condition that might reduce the adherence or tolerance to exercise or fasting
  • Orthopedic or neurologic conditions that might impair exercise training
  • Pregnancy or breastfeeding
  • Abnormalities elicited at exercise treadmill testing that preclude the initiation of exercise training
  • Current engagement in any exercise training protocol

研究组 & 干预措施

HIIT only

Experimental

Volunteers will be submitted to high-intensity interval training (HIIT) performed in fed state

干预措施: High-intensity interval exercise training in the fed state (Behavioral)

CT+FAST

Experimental

Volunteers will be submitted to continous training (CT) performed in the fasting state

干预措施: Continous exercise training in the fasting state (Behavioral)

CT only

Experimental

Volunteers will be submitted to continous training (CT) performed in fed state.

干预措施: Continous exercise training in the fed state (Behavioral)

HIIT+FAST

Experimental

Volunteers will be submitted to high-intensity interval training (HIIT) performed in the fasting state.

干预措施: High-intensity interval exercise training in the fasting state (Behavioral)

结局指标

主要结局

Capillary density

时间窗: 6 months

Number of spontaneously perfused skin capillaries per mm2

次要结局

  • Microvascular reactivity assessed by laser speckle contrast imaging(6 months)

研究者

发起方
National Institute of Cardiology, Laranjeiras, Brazil
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Eduardo Tibirica, MD, PhD

MD, PhD

National Institute of Cardiology, Laranjeiras, Brazil

研究点 (2)

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