Effects of Exercise on Obstructive Sleep Apnea Severity in Elderly

Study Overview
=================
Brief Summary
-----------------
Obstructive sleep apnea syndrome (OSAS) is defined as a total cessation of upper airway flow for at least 10 seconds. OSAS is considered under diagnosed and it is assessed by a full-night sleep polysomnography. Continuous positive airway pressure (CPAP) is considered the first line treatment to OSAS, however physical exercise has emerged as an adjunct and/or alternative strategy to CPAP in OSAS patients.

Detailed Description
-----------------
Obstructive sleep apnea syndrome (OSAS), which comprises repeated episodes of total cessation of upper airway flow during sleep, is an underdiagnosed diasease and is closely related to major physiological desadjustments that compromises the systemic health of the human organism, including triggering death events; It is not surprising, therefore, that the prevalence of OSAS in adults and elderly varies widely. Continuous positive airway pressure (CPAP) is the instrument used as first-line treatment for OSAS because it has significant responses in attenuating the severity of the syndrome, however, the design and logistical operation of the use of this instrument compromise the adherence to OSAS treatment . In this sense, strategies such as regular exercise practice have promising initial results for the treatment of OSAS, despite the gaps that still exist due to the scarcity of studies completed in this area. To this end, it should be noted that studies evaluating the effects of exercise on the severity of OSAS deal mostly with adults / middle-aged adults in aerobic and / or resistance exercise practices performed in a terrestrial environment with alternation only of the ergometer used. Studies on physical exercise and OSAS in the elderly present marked scarcity and only one randomized clinical trial administered to elderly men was found. The prescription of physical exercise for the elderly requires some precautions and precautions arising from the maladjustments that senescence promotes and that compromise the functionality of organic systems. These misfits include, among other things, the attenuation of lean mass with consequent reduction in muscle strength and dynamic balance; Such damages trigger, in the elderly, fall events that, linked to the reduction of bone mineral density due to aging, not infrequently lead to the physical and functional disability of the elderly. Physical exercise performed in the aquatic environment, therefore, emerges as a safe and effective alternative in promoting physical and functional improvements for various populations due to the physical principles of water that promote buoyancy, reduction of joint stress, subjective perception of pain and exercise fatigue. Therefore, the aim of the present study is to evaluate the effects of a 24-week aquatic training program on the severity of obstructive sleep apnea syndrome in older women and is justified in the emerging needs of 1) finding alternative solutions to CPAP use. , 2) use the practice of physical exercise as a tool in mitigating OSAS risk factors and severity; and 3) promote strategies of physical exertion as safe as they are effective for the elderly population to combat OSAS.

Official Title
-----------------
Effects of a 24-week Aquatic Exercise Training Program on Obstructive Sleep Apnea Severity in Elderly Women

Conditions
-----------------
Obstructive Sleep Apnea, Sleep-disordered Breathing, Sleep Disorder; Breathing-Related

Intervention / Treatment
-----------------
* Other: Aquatic exercise training program


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elderly women (60 years old or aged) Apparently healthy High risk to develop OSAS Diagnosed with moderate to severe OSAS No treated to OSAS with CPAP No use of any hypnotic medicine before or during the study Exclusion Criteria: Cardiovascular, pulmonary or metabolic uncontrolled diseases Inability to perform the experimental protocol or keep the usual daily life Morbid obesity by body mass index

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Experimental group: 24-week aquatic exercise training program Control group: maintain life style routine as usual
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental protocol<br>24-week aquatic exercise training program | Other: Aquatic exercise training program<br>* The intervention will be performed in a pool in which the water surface line will remain in the imaginary line of the xiphoid process. Each season will last 50 minutes and will be divided in 3 phases as (1) warm-up (15 minutes), (2) main part (30 minutes) and (3) cool-down (5 minutes).<br>|
| No Intervention: Control protocol<br>Maintain lifestyle routine as usual | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index | Index which defines the OSAS severity. Is evaluated as events per hour by the polysomnography exam | Full-night sleep assessment: up to 8 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-related sleep quality | Questionnaire score assessed by Pittsburgh Questionnaire, classifies self-related sleep quality as follows: as higher was the score as worse sleep quality is. | Face to face interview for 8 minutes | 
| Daytime excessive somnolence | Questionnaire score assessed by Epworth questionnaire which ranges from 0 to 18 and as higher was the score as higher the odds of the individual be considered with Daytime excessive somnolence. | Face to face interview for 3 minutes | 
| Self-related quality of life | Questionnaire score assessed by WHOQOL-Old questionnaire which ranges from 0 to 100 and as higher was the score as higher the odds of the individual be considered with good self-related quality of life. | Face to face interview for 6 minutes | 
| Depressive symptoms | Questionnaire score assessed by Geriatric Depressive Scale which ranges from 0 to 15 and as higher was the score as higher the odds of the individual be evaluated with depressive symptoms suspicious. | Face to face interview for 2 minutes | 
| Oxygen consumption | This outcome will be assessed by a Cardiopulmonary exercise test in a cycle ergometer using Bruce Protocol. | Laboratory exam for 8-12 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Aquatic exercise, Obstructive sleep apnea syndrome, Sleep