Effects of Exercise on Obstructive Sleep Apnea Severity in Elderly

NCT04120428 | Unknown

• 1 other identifier: 05768912401
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Aquatic exercise; Obstructive sleep apnea syndrome; Sleep

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Self-related sleep quality

  Face to face interview for 8 minutes

• Daytime excessive somnolence

  Face to face interview for 3 minutes

• Self-related quality of life

  Face to face interview for 6 minutes

• Depressive symptoms

  Face to face interview for 2 minutes

• Oxygen consumption

  Laboratory exam for 8-12 minutes

Study Arms (2)

Experimental protocol

EXPERIMENTAL

24-week aquatic exercise training program

Other: Aquatic exercise training program

Control protocol

NO INTERVENTION

Maintain lifestyle routine as usual

Interventions

Aquatic exercise training program 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).

Experimental protocol

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Cardiovascular, pulmonary or metabolic uncontrolled diseases
• Inability to perform the experimental protocol or keep the usual daily life
• Morbid obesity by body mass index

Sponsors & Collaborators

• Federal University of Paraíba: lead

Study Sites (1)

Bruno Teixeira Barbosa

João Pessoa, Paraíba, 58051420, Brazil

Location

Related Publications (6)

• 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.

  PMID: 30477841 BACKGROUND

• 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.

  PMID: 29520251 BACKGROUND

• 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.

  PMID: 19898884 BACKGROUND

• 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.

  PMID: 22131599 BACKGROUND

• 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.

  PMID: 28840546 BACKGROUND

• 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.

  PMID: 23794206 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes; Sleep Wake Disorders

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Bruno T Barbosa, PhD Student

  Federal University of Paraiba

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Bruno T Barbosa, PhD Student

CONTACT

+5583998140500; brunobarbosacg@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Master degree

Model Details: Experimental group: 24-week aquatic exercise training program Control group: maintain life style routine as usual

Study Record Dates

• First Submitted: October 7, 2019
• First Posted: October 9, 2019
• Study Start: January 1, 2020
• Primary Completion: December 1, 2020
• Study Completion: December 1, 2020
• Last Updated: October 9, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: The data will be available in the journal elected to publication as supplementary data.
• Access Criteria: All the exercises which will be used in the 24-week aquatic exercise training program will be made available by making unknown the identity of the model.

Locations

BR (1)