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Clinical Trials/NCT03163498
NCT03163498CompletedNot Applicable

Sleep, Mood and Physical Activity Level in Patients With Hypertension

Universidade Federal de Goias1 site in 1 country60 target enrollmentStarted: September 25, 2017Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Exercise

Study Overview

Brief Summary

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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
30 Years to 60 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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.

Outcomes

Primary Outcomes

Exercise

Time Frame: 3 months

Normal Physical Activity Level, Pedometer

Sleep

Time Frame: 3 months

Polysomnography, Pittsburgh Sleep Quality Index

Mood

Time Frame: 3 months

Profile of Mood States

Depression

Time Frame: 3 months

Beck Depression Inventory

Daytime drowsiness

Time Frame: 3 months

Epworth Sleepiness Scale

Anxiety

Time Frame: 3 months

Beck Anxiety Inventory

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Giselle Soares Passos

Professor

Universidade Federal de Goias

Study Sites (1)

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