Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients

Completed

• Conditions: Sleep
• Interventions: Other: No intervantion. It´s a Cross-Sectional Study

• Registration Number: NCT03163498
• Lead Sponsor: Universidade Federal de Goias

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-05-20
• Study First Submitted QC: 2017-05-20
• Study First Posted: 2017-05-23
• Study Start: 2017-09-25
• Primary Completion: 2018-12-30
• Study Completion: 2020-01-06
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 60

Inclusion Criteria

• Diagnosis of systemic arterial hypertension, according to the VII Brazilian Guidelines for Hypertension;
• male;
• 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ACTIVE	No intervantion. It´s a Cross-Sectional Study	Participating in this group will be 30 active hypertension patients who exercise at least 3 times a week for at least 30 minutes
INACTIVE	No intervantion. It´s a Cross-Sectional Study	Participating in this group will be 30 inactive hypertension patients who do not exercise.

Primary Outcome Measures

Name	Time	Method
Exercise	3 months	Normal Physical Activity Level, Pedometer
Sleep	3 months	Polysomnography, Pittsburgh Sleep Quality Index
Depression	3 months	Beck Depression Inventory
Anxiety	3 months	Beck Anxiety Inventory
Daytime drowsiness	3 months	Epworth Sleepiness Scale
Mood	3 months	Profile of Mood States

Trial Locations

Locations (1)

Anna Paula Ribeiro Campos; 🇧🇷 Rio Verde, GO, Brazil