Influence of Interval Aerobic Exercise Training on Cardiorespiratory and Metabolic Variables and Inflammatory Markers in Patients With Different Level of Coronary Artery Lesions
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 68
- 试验地点
- 2
- 主要终点
- Intensity of interval training
研究概览
简要总结
The purpose of this study is to investigate the effects of interval training, based-intensity on 70% at 110% of oxygen consumption and workload attained on ventilatory anaerobic threshold, on aerobic functional capacity, autonomic modulation of heart rate, metabolic profile in patients with and without coronary artery disease.
详细描述
Background: Exercise training has been essential component of the cardiac rehabilitation. However, it is not known if interval training based on ventilatory anaerobic threshold could be effective for improving aerobic functional capacity and metabolic profile.
Objective:To investigate the effects of interval training, based-intensity on 70% at 110% of oxygen consumption and workload attained on ventilatory anaerobic threshold, on aerobic functional capacity, autonomic modulation of heart rate, metabolic profile in patients with and without coronary artery disease.
Design: Prospective randomized controlled trial. Subjects: 68 men between 40 and 65 years old.
All subjects will be submitted:
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- Clinical assessment: personal data, lifestyle and food, family history, current and previous history of disease.
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- Physical examination: cardiac and lung auscultation,measurement of heart rate, blood pressure, body weight and height.
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- Heart rate will be recorded at rest, in the supine position for 15 min, standing position for 10 min and respiratory sinus arrhythmia maneuver.
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- Submaximal or symptom-limited cardiopulmonary exercise test on cycle ergometer will be performed to determined the ventilatory anaerobic threshold.
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- Two cardiopulmonary exercise testing on treadmill at constant workload (moderate and high intensity). Expiratory flow limitation will be evaluated by flow-volume loops at the end of each exercise workload.
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- Blood samples will be collected to analyze glycemic and lipid profiles.
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- After these procedures, the subjects will be randomly assigned to one of two groups, trained group or control group.
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- Interval training program will consist 30-40 minutes each exercise session, three times a week for 16 weeks, with a workload determined on the basis of ventilatory anaerobic threshold.
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- At 48 hours after the last day of training, the subjects will repeat all experimental procedures as in baseline testing. Controls will be retested 16 weeks after the completion of baseline testing.
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- All subjects will be instructed to maintain their habitual diet without a standardized caloric restriction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •All patients will be undergone a medical investigation for coronary artery disease, by coronary angiography, at the Hemodynamics Center of local Hospital.
- •After this procedure, the CAD+ group will include 34 patients, who will have clinical evidence significant stenosis (<50% of stenosis in one or more major coronary vessels), or previous coronary artery intervention (such as percutaneous coronary intervention (PCI) and coronary artery bypass graft (CABG) surgery).
- •The CAD- group will be comprised 32 patients without stenosis in coronary vessels (angiographically documented) and without history of previous myocardial infarction (MI), PCI or CABG.
- •All the patients will have three or more cardiovascular risk factors such as obesity (body mass index >30 kg/m2), smoking, sedentary lifestyle according to the International Physical Activity Questionnaire (IPAQ) version 6, hypertension, diabetes mellitus (type 2 - nonusers of insulin), and dyslipidemia.
排除标准
- •The exclusion criteria consisted of MI <6 months, PCI and CABG <3 months
- •Severe cardiac arrhythmias
- •Chronic obstructive pulmonary disease
- •Unstable angina
- •Osteomuscular disorders
- •Diabetes mellitus (users of insulin)
- •Renal failure
- •Sequelae associated with stroke.
结局指标
主要结局
Intensity of interval training
时间窗: 40 min
The IT intensity levels will be prescribed based on workload (W) attained at ventilatory anaerobic threshold, i. e., at 70%, 80%, 100% and 110%
次要结局
- Aerobic functional capacity(baseline and after interval training period (16 weeks))
- Metabolic profile(baseline and after interval training period (16 weeks))
- Expiratory flow limitation(Expiratory flow limitation will be evaluated by flow-volume loops at the end of each exercise workload)
- Autonomic modulation of heart rate(baseline and after interval training period (16 weeks))
研究者
Nayara Yamada Tamburús
M.D.
Universidade Federal de Sao Carlos