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临床试验/NCT02976506
NCT02976506已完成不适用

Safety of an Unsupervised Physical Activity Program and Effects Over Blood Pressure, Physical Fitness and Quality of Life of Elderly Hypertensive Patients

Universidade Federal de Goias2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2014年3月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Lower Blood Pressure and or keeping it under control

研究概览

简要总结

To evaluate safety and the effects of a unsupervised physical activity program (USPAP) over blood pressure (BP), physical fitness (PF) and quality of life (QL) of elderly hypertensive patients.

详细描述

The present study was approved by the Human and Animal Ethics Committee of the institution and the participants were only randomized to participate after having signed the informed consent form.

A population of elderly hypertensive patients registered at a reference center for hypertension treatment was selected. The sample size was calculated considering a test power of 80% with significance level of 5% and estimating a difference to be observed within the BP values of 7 mmHg for systolic blood pressure (SBP) and 4 mmHg for diastolic blood pressure (DBP). The sample calculated was 25 participants in each group being selected 20% more in case of losses.

An electronic chart was created with numbers for the patients that were randomized into control (CG) and intervention groups (IG).

The IG was included in an USPAP and the control group was kept under the usual care of the service that includes orientation to perform PA according to the World Health Organization recommendations.

Before the beginning of the protocol clinical and laboratorial data collected included: weight, height, waist circumference, fasting glucose, hemoglobin A1C and lipid profile.

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
Single (Participant)

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Lower Blood Pressure and or keeping it under control

时间窗: 12 weeks

次要结局

  • Quality of life(12 weeks)
  • Improve Cardiorespiratory fitness.(12 weeks)
  • Improve abdominal strength.(12 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Silva Carneiro

Principal Investigator

Universidade Federal de Goias

研究点 (2)

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