Effects of Exercise on Obstructive Sleep Apnea Severity in Elderly

NCT ID: NCT04120428

Last Updated: 2019-10-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-31

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Experimental group: 24-week aquatic exercise training program Control group: maintain life style routine as usual
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental protocol

24-week aquatic exercise training program

Group Type EXPERIMENTAL

Aquatic exercise training program

Intervention Type OTHER

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).

Control protocol

Maintain lifestyle routine as usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Aquatic exercise training program

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).

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Federal University of Paraíba

OTHER

Sponsor Role lead

Responsible Party

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Bruno Teixeira Barbosa

Master degree

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bruno T Barbosa, PhD Student

Role: PRINCIPAL_INVESTIGATOR

Federal University of Paraiba

Locations

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Bruno Teixeira Barbosa

João Pessoa, Paraíba, Brazil

Site Status

Countries

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Brazil

Central Contacts

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Bruno T Barbosa, PhD Student

Role: CONTACT

+5583998140500

Facility Contacts

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Bruno T Barbosa, PhD Student

Role: primary

References

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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.

Reference Type BACKGROUND
PMID: 30477841 (View on PubMed)

Mendelson M, Bailly S, Marillier M, Flore P, Borel JC, Vivodtzev I, Doutreleau S, Verges S, Tamisier R, Pepin JL. Obstructive Sleep Apnea Syndrome, Objectively Measured Physical Activity and Exercise Training Interventions: A Systematic Review and Meta-Analysis. Front Neurol. 2018 Feb 22;9:73. doi: 10.3389/fneur.2018.00073. eCollection 2018.

Reference Type BACKGROUND
PMID: 29520251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19898884 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22131599 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28840546 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23794206 (View on PubMed)

Other Identifiers

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05768912401

Identifier Type: -

Identifier Source: org_study_id

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