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Effects of Exercise on Obstructive Sleep Apnea Severity in Elderly

Primary Purpose

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

Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Aquatic exercise training program
Sponsored by
Federal University of Paraíba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring Aquatic exercise, Obstructive sleep apnea syndrome, Sleep

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Bruno Teixeira Barbosa

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental protocol

Control protocol

Arm Description

24-week aquatic exercise training program

Maintain lifestyle routine as usual

Outcomes

Primary Outcome Measures

Apnea-Hypopnea Index
Index which defines the OSAS severity. Is evaluated as events per hour by the polysomnography exam

Secondary Outcome Measures

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.
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.
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.
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.
Oxygen consumption
This outcome will be assessed by a Cardiopulmonary exercise test in a cycle ergometer using Bruce Protocol.

Full Information

First Posted
October 7, 2019
Last Updated
October 7, 2019
Sponsor
Federal University of Paraíba
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1. Study Identification

Unique Protocol Identification Number
NCT04120428
Brief Title
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

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 2020 (Anticipated)
Primary Completion Date
December 2020 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Federal University of Paraíba

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea, Sleep-disordered Breathing, Sleep Disorder; Breathing-Related
Keywords
Aquatic exercise, Obstructive sleep apnea syndrome, Sleep

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Experimental group: 24-week aquatic exercise training program Control group: maintain life style routine as usual
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental protocol
Arm Type
Experimental
Arm Description
24-week aquatic exercise training program
Arm Title
Control protocol
Arm Type
No Intervention
Arm Description
Maintain lifestyle routine as usual
Intervention Type
Other
Intervention Name(s)
Aquatic exercise training program
Intervention Description
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).
Primary Outcome Measure Information:
Title
Apnea-Hypopnea Index
Description
Index which defines the OSAS severity. Is evaluated as events per hour by the polysomnography exam
Time Frame
Full-night sleep assessment: up to 8 hours
Secondary Outcome Measure Information:
Title
Self-related sleep quality
Description
Questionnaire score assessed by Pittsburgh Questionnaire, classifies self-related sleep quality as follows: as higher was the score as worse sleep quality is.
Time Frame
Face to face interview for 8 minutes
Title
Daytime excessive somnolence
Description
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.
Time Frame
Face to face interview for 3 minutes
Title
Self-related quality of life
Description
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.
Time Frame
Face to face interview for 6 minutes
Title
Depressive symptoms
Description
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.
Time Frame
Face to face interview for 2 minutes
Title
Oxygen consumption
Description
This outcome will be assessed by a Cardiopulmonary exercise test in a cycle ergometer using Bruce Protocol.
Time Frame
Laboratory exam for 8-12 minutes

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Bruno T Barbosa, PhD Student
Phone
+5583998140500
Email
brunobarbosacg@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno T Barbosa, PhD Student
Organizational Affiliation
Federal University of Paraiba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bruno Teixeira Barbosa
City
Joao Pessoa
State/Province
Paraíba
ZIP/Postal Code
58051420
Country
Brazil
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bruno T Barbosa, PhD Student

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The authors will make the data available based on journal guidelines selected to make the article published.
IPD Sharing Time Frame
The data will be available in the journal elected to publication as supplementary data.
IPD Sharing 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.
Citations:
PubMed Identifier
30477841
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.
Results Reference
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PubMed Identifier
29520251
Citation
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.
Results Reference
background
PubMed Identifier
19898884
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.
Results Reference
background
PubMed Identifier
22131599
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.
Results Reference
background
PubMed Identifier
28840546
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. Erratum In: Sleep Breath. 2018 Feb 13;:
Results Reference
background
PubMed Identifier
23794206
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.
Results Reference
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Effects of Exercise on Obstructive Sleep Apnea Severity in Elderly

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