Clinical trial NCT03163498: Evaluation of Sleep Pattern and Mood Profile in Hypertensive Patients
Official title: Sleep, Mood and Physical Activity Level in Patients With Hypertension
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Sleep
Keywords: Hypertension
Exercise
Sleep
Lead sponsor: Universidade Federal de Goias
Sponsor class: OTHER
First posted: 2017-05-23
Enrollment: 60
Sex: MALE
Minimum age (years): 30
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Participating in the study will be 60 males hypertension patients (ACTIVE, n=30; INACTIVE, n=30) with age between 30 and 60 years old. All participants should be under antihypertensive drug treatment.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Sleep
timeFrame: 3 months
measure: Exercise
timeFrame: 3 months
measure: Mood
timeFrame: 3 months
measure: Anxiety
timeFrame: 3 months
measure: Depression
timeFrame: 3 months
measure: Daytime drowsiness
timeFrame: 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: Rio Verde
country: Brazil
facility: Anna Paula Ribeiro Campos
state: GO
Study officials:
affiliation: World Health Organization
name: Giselle Passos, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Passos GS, Poyares D, Santana MG, Teixeira AA, Lira FS, Youngstedt SD, dos Santos RV, Tufik S, de Mello MT. Exercise improves immune function, antidepressive response, and sleep quality in patients with chronic primary insomnia. Biomed Res Int. 2014;2014:498961. doi: 10.1155/2014/498961. Epub 2014 Sep 21.
citation: Passos GS, Poyares DL, Santana MG, Tufik S, Mello MT. Is exercise an alternative treatment for chronic insomnia? Clinics (Sao Paulo). 2012;67(6):653-60. doi: 10.6061/clinics/2012(06)17.
citation: Passos GS, Santana MG, Poyares D, D'Aurea CV, Teixeira AA, Tufik S, de Mello MT. Chronotype and anxiety are associated in patients with chronic primary insomnia. Braz J Psychiatry. 2017 Apr-Jun;39(2):183-186. doi: 10.1590/1516-4446-2016-2007. Epub 2017 Jan 9.