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临床试验/NCT04126785
NCT04126785招募中不适用

Effects of High-Intensity Interval Versus Moderate-Intensity Continuous Heated Water-Based Exercise on Blood Pressure and Hemodynamic Variables in Older Individuals With Hypertension

Universidade Estadual Paulista Júlio de Mesquita Filho2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2019年11月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
60
试验地点
2
主要终点
Change from baseline Blood Pressure (Systolic and Diastolic) following 12 weeks of exercise.

研究概览

简要总结

This study will investigate the acute and chronic effects in hemodynamic and autonomic variables to high-intensity interval versus moderate-intensity continuous heated water-based exercise in older individuals with hypertension.

详细描述

BACKGROUND: Population aging is an unprecedented worldwide reality, which results in a change of epidemiological profile and increased prevalence of age-related non-communicable chronic diseases (NCDs). Among age-related NCDs, systemic arterial hypertension (HPT) is the leading cause of mortality and disability worldwide and has increased prevalence, morbidity and mortality with advancing age. Increase in physical activity level through regular physical exercise is one of the main global goals for the prevention and treatment of HPT and others NCDs. Among the different exercise types and intensities, high intensity interval exercise (HIIT) showed superior benefits for reducing blood pressure (BP) and improving variables involved in the pathophysiology of HPT when compared to continuous moderate-intensity exercise (MICE). However individuals with comorbidities or injures are not capable to follow adequate intensity of both types of exercise. Heated water-based has been used as an option to facilitate the individuals adherence to exercise and positive results especially in BP levels. Despite this, little is known about the effect of HIIT or MICE in heated water-based on BP and other hemodynamic variables involved in the pathophysiology of HPT in older hypertensive individuals. PURPOSE: To evaluate the hemodynamic and autonomic response to a HIIT versus MICE session and in 12 weeks of training in older individuals with hypertension. METHODS: 60 elderly hypertensives of both genders, aged over 60 years, will be randomized in the ratio 2: 2: 1 to 12 weeks of high intensity interval training (HIIT), moderate intensity continuous (MICE) or control follow-up without exercise (CON), respectively. Exercise programs will be discontinued after 12 weeks, and individuals will be followed up for another 12 weeks. Individuals will have their physical (cardiorespiratory and muscular) and functional capacity (walking, sitting and lifting ability), hemodynamic variables (blood pressure, arterial stiffness, endothelial function and cardiovascular response to exercise) and autonomic variables (variability of heart rate) and quality of life assessed before and after 12 and 24 weeks of follow-up. Before the beginning of the follow-up, 20 elderly hypertensive patients will also have a hemodynamic response (ambulatory blood pressure, endothelial function, arterial stiffness) and autonomic (heart rate variability) to a session of HI-HEx, MI-HEx and CON evaluated and compared. The feasibility of HIIE and MICE will also be assessed over the 12 weeks of its implementation. HIIT will consisted of warm up (4 min), 21 min of 1 min high intensity exercise (level 15) and "very hard" (level 17) of the subjective Rating of Perceived Exertion Scale (RPE) alternating with 2 min of walking at intensity between "easy" (level 9) and "fairly easy" (level 11) of the RPE. MICE will performed of 4 min warm up and 26 min of walking or jogging at intensity between "fairly light" (level 11) and " somewhat hard " (level 13) of the RPE.

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
Double (Investigator, Outcomes Assessor)

盲法说明

In study 1 and 2 the participants will be aleatory randomized and the main investigator will perform the exercise session. The data will collected and assessed by a blinded investigator without knowledge of participants intervention.

入排标准

年龄范围
60 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ≥60 years old;
  • Hypertension diagnosed at least 6 months earlier (stage 1 or 2);
  • Antihypertensive drug treatment and without dosage alteration at least 3 months earlier;
  • Blood pressure inferior to 140/90 mmHg in medical office.
  • Non-inclusion criteria:
  • Smoking individuals;
  • Uncontrolled cardiovascular disease;
  • Disability;
  • Deficit cognitive;

排除标准

  • Non 100% participation;
  • Change (or stopped) clinical or drug treatment.

研究组 & 干预措施

Control without exercise in heated water-based

Placebo Comparator

CON session will perform at controlled heated water-base (30 e 32 ºC). Subject will be seated in a chair and submerged at the xiphoid process level for 30 min.

干预措施: Control Group (Other)

High Intensity Interval Exercise in Heated Water

Experimental

High intensity interval exercise will perform at controlled heated water-base (30 e 32 ºC). Subject will be submerged at the xiphoid process level. The session will consist in 4 min walking (warm-up) at 9 level of rate perceived exertion (RPE) scale, followed by 21 min of HIIE, alternating 1 min of jogging/running at 15-17 (hard-very hard) level with 2 min of walking at 9-11 (very light-fairly light) level of RPE.

干预措施: High Intensity Interval Exercise in Heated Water-Based (Other)

Continuous Moderate Exercise in Heated Water

Experimental

Continuous moderate exercise will perform at controlled heated water-base (30 e 32 ºC). Subject will be submerged at the xiphoid process level. The session will consist in 4 min walking (warm-up) at 9 level (light) of RPE, followed by 26 min of MICE, walking at 11-13 (fairly light) level of RPE.

干预措施: Continuous Moderate Exercise in Heated Water-Based (Other)

结局指标

主要结局

Change from baseline Blood Pressure (Systolic and Diastolic) following 12 weeks of exercise.

时间窗: 12 weeks

Blood pressure will be assessed in resting (Omron HEM 7200®, Omron Healthcare Inc, Dalian, China) at the day of the sessions and using a 24 hour ambulatory blood pressure monitoring (Cardio-Mapa ®, Cardios System Ltda, Sao Paulo, Brazil), at the baseline and after 12 weeks of exercise.

次要结局

  • Effect of exercise in hemodynamic and autonomic variables assessed by endothelial function, arterial stiffness and heart rate variability(12 weeks)
  • Effect of exercise in functional capacity assessed by handgrip strength test.(12 weeks)
  • Effect of exercise in functional capacity assessed by 5 times sit to stand test.(12 weeks)
  • Effect of exercise in functional capacity assessed by sit and reach test.(12 weeks)
  • Effect of exercise in functional capacity assessed by timed up and go test.(12 weeks)
  • Effect of exercise in functional capacity assessed by 6 minutes walk test.(12 weeks)
  • Quality of Life assessed by International Physical Activity Questionnaire(12 weeks)

研究者

发起方
Universidade Estadual Paulista Júlio de Mesquita Filho
申办方类型
Other
责任方
Principal Investigator
主要研究者

Emmanuel Gomes Ciolac

Principal Investigator

Universidade Estadual Paulista Júlio de Mesquita Filho

研究点 (2)

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