Effects of Exercise on Obstructive Sleep Apnea Severity in Elderly

Obstructive Sleep Apnea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04120428
• Other study ID #: 05768912401
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2020
• Est. completion date: December 2020

Study information

• Verified date: October 2019
• Source: Federal University of Paraíba
• Contact: Bruno T Barbosa, PhD Student
• Phone: +5583998140500
• Email: brunobarbosacg[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 32
• Est. completion date: December 2020
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Respiratory Aspiration
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive
• Sleep Disorder; Breathing-Related
• Sleep Wake Disorders
• Sleep-disordered Breathing

Intervention

Other:
• 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).

Locations

Country	Name	City	State
Brazil	Bruno Teixeira Barbosa	Joao Pessoa	Paraíba

Sponsors (1)

Lead Sponsor	Collaborator
Federal University of Paraíba

Country where clinical trial is conducted

Brazil, 

References & Publications (6)

Barbosa BT, da Cruz Santos A, Frazão 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. Erratum in: Sleep Breath. 2018 Feb 13;:. — View 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. — View 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. — View Citation

Mendelson M, Bailly S, Marillier M, Flore P, Borel JC, Vivodtzev I, Doutreleau S, Verges S, Tamisier R, Pépin 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. — View 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. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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