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临床试验/NCT03163498
NCT03163498已完成不适用

Sleep, Mood and Physical Activity Level in Patients With Hypertension

Universidade Federal de Goias1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月25日最近更新:
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
1
主要终点
Exercise

研究概览

简要总结

Introduction: Sleep disturbances may contribute to impairments in mood, occupational and intellectual performance, and social relationships, as well as being associated with cardiovascular diseases, such as arterial hypertension. Sedentary lifestyle has often been associated with poor sleep quality and hypertension; regular exercise has been studied as a coadjuvant therapy for hypertension and/or for some sleep disorders. Objective: To compare sleep pattern of active and inactive patients with arterial hypertension, as well as to evaluate complaints of depression and anxiety, and the mood profile. Material and Methods: Polysomnography, Pittsburgh Sleep Quality Index and Epworth Sleepiness Scale will be used to assess the sleep pattern. Depression will be assessed by the Beck Depression Inventory (BDI), Beck Anxiety Inventory (BAI) anxiety, and mood pattern by the State of Mood Profile (POMS). The level of physical activity will be recorded by the number of steps taken (pedometer). Participating in the study will be 60 hypertension patients (ACTIVE, n=30; INACTIVE, n=30). Hypothesis: Active hypertensive patients better quality of sleep, better mood profile, and fewer complaints of depression and anxiety when compared to physically inactive hypertensive patients.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Cross Sectional

入排标准

年龄范围
30 Years 至 60 Years(Adult)
性别
Male
接受健康志愿者

入选标准

  • Diagnosis of systemic arterial hypertension, according to the VII Brazilian Guidelines for Hypertension;
  • BMI <30;
  • Age between 30 and 60 years;
  • Minimum level of education: elementary school

排除标准

  • Present pathologies in the musculoskeletal and neurological systems, or incapacitating complaints in these systems;
  • Diagnosis of psychiatric disorder;
  • Being under medical treatment for insomnia or other psychiatric treatment.

结局指标

主要结局

Exercise

时间窗: 3 months

Normal Physical Activity Level, Pedometer

Sleep

时间窗: 3 months

Polysomnography, Pittsburgh Sleep Quality Index

Mood

时间窗: 3 months

Profile of Mood States

Depression

时间窗: 3 months

Beck Depression Inventory

Daytime drowsiness

时间窗: 3 months

Epworth Sleepiness Scale

Anxiety

时间窗: 3 months

Beck Anxiety Inventory

次要结局

未报告次要终点

研究者

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

Giselle Soares Passos

Professor

Universidade Federal de Goias

研究点 (1)

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