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Post-Exercise Hypotension in Elderly Hypertensive Men (HPE)

2018年5月29日 更新者:Hospital de Clinicas de Porto Alegre

Effects of Different Exercises on Post-Exercise Blood Pressure in Elderly Hypertensive: A Cross-Over Randomized Clinical Trial

The purpose of this study is to compare the effects of two exercise protocols on post-exercise blood pressure versus a control group in elderly hypertensive men. Participants are allocated to all groups: control group and two experimental exercise protocols, in a random order. In the control group, participants remain resting sitting, and, in the exercise protocols, participants practice exercise bouts of aerobic exercise or a combination of resistance and aerobic exercises. In order to standardize baseline conditions, before the sessions subjects remain sitting quietly for 20 minutes. After each exercise protocol, participants have 60 minutes for recovery and, simultaneously, they have BP measured every 5 minutes. After the exercise sessions or control, an equipment for 24 hours ambulatory BP monitoring is installed in every participant.

研究概览

详细说明

Hypertension has high prevalence and low rate of control, and is a major modifiable risk factor and public health problem. Regular physical exercise is a relevant non-pharmacological option for prevention and treatment of hypertension. Several studies demonstrated a reduction in blood pressure (BP) following different exercise protocols, and the decrease may be the result of the summation of hypotensive effects that occur in the hours following the workout. The reduction resulting from a single exercise session is called post-exercise hypotension (PEH) and has been investigated among hypertensive subjects. However, to achieve clinical relevance the PEH should reach a significant magnitude and the reduction should be sustained for a longer period.

Previous studies showed the positive effects of aerobic exercise on post-exercise hypotension in hypertensive subjects. However, there is lacking evidence regarding the effects of a single session of aerobic and resistance exercise combined, and the duration of its effect in 24 hours blood pressure in elderly hypertensive subjects.

The study is an open, crossover randomized clinical trial, with elderly men allocated to three arms, in a random order:

  • Aerobic training session
  • Combined resistance training and aerobic session
  • Control session

After each exercise session, participants have 60 minutes for recovery, performed in the sitting position, with BP measurements every 5 minutes. In addition, participants have measured BP using 24h ambulatory BP monitoring. At the end of the trial, participants will have completed all three experimental protocols: a non-exercise control session, of sitting rest, and two exercise bouts, one of aerobic exercise and a combined resistance and aerobic exercise, with seven days of washout period among sessions. All experiments will be conducted at the same time of day to account for diurnal BP variation. Before the experimental sessions, participants are enrolled in three pre-intervention tests: a familiarization session, cardiopulmonary exercise testing and one maximum repetition strength test (1RM). The aerobic sessions last for 45 minutes, as well as the resistance exercises, and the session of control.

研究类型

介入性

注册 (实际的)

20

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

    • Rio Grande Do Sul
      • Porto Alegre、Rio Grande Do Sul、巴西、90035-903
        • Hospital de Clinicas de Porto Alegre

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

60年 至 70年 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

男性

描述

Inclusion Criteria:

  • Essential hypertension grade 1 - 2 with or without medical treatment:

resting systolic blood pressure (SBP) ≥ 140 mmHg or diastolic blood pressure (DBP) ≥ 90 mmHg

Exclusion Criteria:

  • Smoking;
  • Bone, joint, or muscle problems that could limit the performance of the exercises.
  • BMI ≥ 30 kg/m2
  • Heart Attack in the last year

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:治疗
  • 分配:随机化
  • 介入模型:交叉作业
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Aerobic exercise
Aerobic exercise on treadmill at 65-70% of the heart rate reserve during a session.
Aerobic exercise on treadmill
实验性的:Combined exercises
A session combines resistance and aerobic exercises, with aerobic exercise on treadmill at 65-70% of the heart rate reserve, followed by 60 minutes for cardiorespiratory recovery, and resistance exercise.
Combined resistance and aerobic exercise
假比较器:Control
Participants do not exercise and remain sitting for 45 minutes
45 minutes resting sitting

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
Ambulatory Blood Pressure Monitoring
大体时间:24 hours
Ambulatory blood pressure monitoring following experimental protocols
24 hours

次要结果测量

结果测量
措施说明
大体时间
Office Blood Pressure
大体时间:1 hour
Post exercise blood pressure during 60 minutes after experimental sessions
1 hour

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

  • 首席研究员:Sandra C Fuchs, PhD、Hospital de Clinicas de Porto Alegre

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

2014年3月1日

初级完成 (实际的)

2015年12月1日

研究完成 (实际的)

2015年12月1日

研究注册日期

首次提交

2015年4月9日

首先提交符合 QC 标准的

2015年4月13日

首次发布 (估计)

2015年4月14日

研究记录更新

最后更新发布 (实际的)

2018年5月31日

上次提交的符合 QC 标准的更新

2018年5月29日

最后验证

2015年8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.

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