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Status unknownNCT04120428Updated Oct 9, 2019

Effects of Exercise on Obstructive Sleep Apnea Severity in Elderly

An interventional study of Aquatic exercise training program in Obstructive Sleep Apnea, Sleep-disordered Breathing and Sleep Disorder; Breathing-Related, sponsored by Federal University of Paraíba. Status unknown at 1 site in Brazil. Open to female participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2019-10-09.

Sponsored by Federal University of Paraíba · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2019), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
32
Allocation
Randomized
Ages
60 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

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

Keywords

  • Aquatic exercise
  • Obstructive sleep apnea syndrome
  • Sleep
03

In context

Apnea

1,422 studies on the registry are indexed under Apnea; 159 are open to participants now.

This study's planned enrollment of 32 is below the median of 50 across 965 interventional studies indexed under Apnea.

Browse Apnea studies →

Lead sponsor

Federal University of Paraíba is the lead sponsor of 72 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
60 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
32 participants (estimated)

Study arms

  • Experimental
    Experimental protocol

    24-week aquatic exercise training program

    Other: Aquatic exercise training program

  • No intervention
    Control protocol

    Maintain lifestyle routine as usual

Interventions

  • OtherAquatic 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).

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What researchers measure

Primary outcomes

  1. Apnea-Hypopnea Index

    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 outcomes

  1. 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.

    Time frame: Face to face interview for 8 minutes

  2. 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.

    Time frame: Face to face interview for 3 minutes

  3. 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.

    Time frame: Face to face interview for 6 minutes

  4. 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.

    Time frame: Face to face interview for 2 minutes

  5. Oxygen consumption

    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

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Study locations

1 site
  • Bruno Teixeira Barbosa
    Joao Pessoa, Paraíba 58051420, Brazil
    • Bruno T Barbosa, PhD Student · Contact
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References and documents

Publications

  • 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. PubMed 30477841 ↗
  • 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. PubMed 29520251 ↗
  • 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. PubMed 19898884 ↗
  • 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. PubMed 22131599 ↗
  • 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 May;22(2):439-440. doi: 10.1007/s11325-018-1627-5. PubMed 28840546 ↗
  • 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. PubMed 23794206 ↗

Individual participant data

Plan to share: Yes — The authors will make the data available based on journal guidelines selected to make the article published.

Supporting information: Study protocol

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 9, 2019, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04120428
Lead sponsor
Federal University of Paraíba
Responsible party
Bruno Teixeira Barbosa (Master degree, Federal University of Paraíba) — Principal investigator
First posted
Oct 9, 2019
Start date
Jan 2020 (estimated)
Primary completion
Dec 2020 (estimated)
Completion
Dec 2020 (estimated)
Last update
Oct 9, 2019

Study contacts

Bruno T Barbosa, PhD Student
Contact
brunobarbosacg@gmail.com
+5583998140500
Bruno T Barbosa, PhD Student
principal investigator · Federal University of Paraiba

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is status unknown, as verified in Oct 2019. You cannot join it, but the record below documents what was studied.

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