Clinical trial NCT04120428: Effects of Exercise on Obstructive Sleep Apnea Severity in Elderly
Official title: Effects of a 24-week Aquatic Exercise Training Program on Obstructive Sleep Apnea Severity in Elderly Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Obstructive Sleep Apnea
Sleep-disordered Breathing
Sleep Disorder; Breathing-Related
Keywords: Aquatic exercise
Obstructive sleep apnea syndrome
Sleep
Lead sponsor: Federal University of Paraíba
Sponsor class: OTHER
First posted: 2019-10-09
Enrollment: 32
Sex: FEMALE
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Experimental group: 24-week aquatic exercise training program Control group: maintain life style routine as usual
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Apnea-Hypopnea Index
timeFrame: Full-night sleep assessment: up to 8 hours
Secondary outcomes:
measure: Self-related sleep quality
timeFrame: Face to face interview for 8 minutes
measure: Daytime excessive somnolence
timeFrame: Face to face interview for 3 minutes
measure: Self-related quality of life
timeFrame: Face to face interview for 6 minutes
measure: Depressive symptoms
timeFrame: Face to face interview for 2 minutes
measure: Oxygen consumption
timeFrame: Laboratory exam for 8-12 minutes
Other outcomes:
Locations:
city: Joao Pessoa
country: Brazil
facility: Bruno Teixeira Barbosa
state: Paraíba
Study officials:
affiliation: Federal University of Paraiba
name: Bruno T Barbosa, PhD Student
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bollens B, Reychler G. Efficacy of exercise as a treatment for Obstructive Sleep Apnea Syndrome: A systematic review. Complement Ther Med. 2018 Dec;41:208-214. doi: 10.1016/j.ctim.2018.10.002. Epub 2018 Oct 3.
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citation: Sengul YS, Ozalevli S, Oztura I, Itil O, Baklan B. The effect of exercise on obstructive sleep apnea: a randomized and controlled trial. Sleep Breath. 2011 Jan;15(1):49-56. doi: 10.1007/s11325-009-0311-1. Epub 2009 Nov 7.
citation: Kline CE, Crowley EP, Ewing GB, Burch JB, Blair SN, Durstine JL, Davis JM, Youngstedt SD. The effect of exercise training on obstructive sleep apnea and sleep quality: a randomized controlled trial. Sleep. 2011 Dec 1;34(12):1631-40. doi: 10.5665/sleep.1422.
citation: Barbosa BT, da Cruz Santos A, Frazao M, Petrucci TR, Cucato GG, Sarmento AO, Freitas EDS, de Lima AMJ, Brasileiro-Santos MDS. Obstructive sleep apnea does not impair cardiorespiratory responses to progressive exercise performed until exhaustion in hypertensive elderly. Sleep Breath. 2018 May;22(2):431-437. doi: 10.1007/s11325-017-1557-7. Epub 2017 Aug 24.
citation: Tam S, Woodson BT, Rotenberg B. Outcome measurements in obstructive sleep apnea: beyond the apnea-hypopnea index. Laryngoscope. 2014 Jan;124(1):337-43. doi: 10.1002/lary.24275. Epub 2013 Jul 9.