Intensity Training and Cardiovascular Health in Colombian Adults (HIIT-Heart)
2016年10月24日 更新者：Robinson Ramírez-Vélez、Universidad Santo Tomas
High Intensity Interval- vs Moderate Training on Biomarkers of Endothelial and Cardiovascular Health in Adults: Effect of Postprandial Period
Several studies have shown relationship between exercise intensity and improvement cardiometabolic health.
It has been suggested that high intensity interval training and also moderate training generate positive effects on metabolic risk factors.
For these reasons, it is necessary to clarify which type of training, is more effective to improve cardiometabolic health in latinamerican population.
研究概览
研究类型
介入性
注册 (实际的)
30
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Bogotá、哥伦比亚
- Robinson Ramírez Vélez Ph.D
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
20年 至 45年 (成人)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Written informed consent.
- Interested in improving health and fitness.
Exclusion Criteria:
- 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).
- Asthma.
- 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.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：预防
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
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实验性的：High Intensity Interval Training
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 until the end of training.
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Exercise will be performed at three sessions per week.
All sessions will be supervised by a trained health or exercise professional.
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有源比较器：Moderate Intensity Interval Training
Walking on a treadmill at 60-80% peak heart rate until expenditure of 300 kcal until the end of training.
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Exercise will be performed at three sessions per week.
All sessions will be supervised by a trained health or exercise professional.
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in endothelial function as measured by flow-mediated vasodilation (FMD)
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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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
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Change from Baseline in LDL Cholesterol
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in HDL Cholesterol
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Triglycerides
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Glucose
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Heart rate variability
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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HRV will be performed according to current recommendations by European Society of Cardiology using an evaluated share-ware
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Aortic pulse wave velocity (PWVao)
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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PWVao (m s-1) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph.
The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured PWVao values was less than 1.1 m/sec).
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in muscular fitness
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Muscular fitness (MF) will be assessed using handgrip test (maximum handgrip strength assessment) using a standard adjustable handle analogue handgrip dynamometer T-18 TKK SMEDLY III®
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Flexibility using the sit and reach test
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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It will be determined using a maximum treadmill exercise test (Precor TRM 885, Italy) following the modified Balke protocol
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in peak uptake of volume of oxygen
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Blood Pressure
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Body Mass Index
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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BMI will be calculated as the body weight in kilograms divided by the square of the height in meters.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Body Mass
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Change from Baseline in Quality & satisfaction with life by SF Community - short-form survey (SF-12™) Colombian version
大体时间：Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Baseline and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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Augmentation index (AIx)
大体时间：Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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AIx (%) will be performed within 3 to 4 minutes with the oscillometric, occlusive device, the Arteriograph.
The measurement will be taken in a supine position and were accepted if the quality indicator of the recordings was within the acceptable range (i.e., if the standard deviation [SD] of the beat-to-beat measured AIx values was less than 1.1 m/sec).
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Baseline, 2 and 12 weeks immediately after the interventions ends, preceding an 'unhealthy' meal.
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Robinson Ramírez Vélez, Ph.D、Universidad del Rosario
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Effect of Moderate- Versus High-Intensity Interval Exercise Training on Heart Rate Variability Parameters in Inactive Latin-American Adults: A Randomized Clinical Trial. J Strength Cond Res. 2020 Dec;34(12):3403-3415. doi: 10.1519/JSC.0000000000001833.
- Ramirez-Velez R, Hernandez-Quinones PA, Tordecilla-Sanders A, Alvarez C, Ramirez-Campillo R, Izquierdo M, Correa-Bautista JE, Garcia-Hermoso A, Garcia RG. Effectiveness of HIIT compared to moderate continuous training in improving vascular parameters in inactive adults. Lipids Health Dis. 2019 Feb 4;18(1):42. doi: 10.1186/s12944-019-0981-z.
- Ramirez-Velez R, Correa-Rodriguez M, Tordecilla-Sanders A, Aya-Aldana V, Izquierdo M, Correa-Bautista JE, Alvarez C, Garcia-Hermoso A. Exercise and postprandial lipemia: effects on vascular health in inactive adults. Lipids Health Dis. 2018 Apr 3;17(1):69. doi: 10.1186/s12944-018-0719-3.
- Ramirez-Velez R, Tordecilla-Sanders A, Tellez-T LA, Camelo-Prieto D, Hernandez-Quinonez PA, Correa-Bautista JE, Garcia-Hermoso A, Ramirez-Campillo R, Izquierdo M. Similar cardiometabolic effects of high- and moderate-intensity training among apparently healthy inactive adults: a randomized clinical trial. J Transl Med. 2017 May 30;15(1):118. doi: 10.1186/s12967-017-1216-6. Erratum In: J Transl Med. 2017 Jun 13;15(1):136.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2015年6月1日
初级完成 (实际的)
2016年10月1日
研究完成 (实际的)
2016年10月1日
研究注册日期
首次提交
2016年3月23日
首先提交符合 QC 标准的
2016年4月8日
首次发布 (估计)
2016年4月14日
研究记录更新
最后更新发布 (估计)
2016年10月25日
上次提交的符合 QC 标准的更新
2016年10月24日
最后验证
2016年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.