Obstructive Sleep ApneaNCT04120428
Effects of Exercise on Obstructive Sleep Apnea Severity in Elderly
A study testing Aquatic exercise training program in people with Obstructive Sleep Apnea and Sleep-disordered Breathing, run by Federal University of Paraíba at 1 site in Brazil.
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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Obstructive Sleep Apnea, Sleep-disordered Breathing, Sleep Disorder; Breathing-Related
- What is being tested?
- Aquatic exercise training program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2020to Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Cardiovascular, pulmonary or metabolic uncontrolled diseases
- Inability to perform the experimental protocol or keep the usual daily life
- Morbid obesity by body mass index
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Bruno Teixeira Barbosa
João Pessoa, Paraíba, 58051420
Bruno T Barbosa, PhD Student
About this study
Official title: Effects of a 24-week Aquatic Exercise Training Program on Obstructive Sleep Apnea Severity in Elderly Women
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.
- Being tested
- Aquatic exercise training program
- Keywords
- Aquatic exercise, Obstructive sleep apnea syndrome, Sleep
- Medical subject headings
- Sleep Apnea, Obstructive, Sleep Apnea Syndromes, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aquatic exercise training programOther
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).
| Study group | Role | What they receive |
|---|---|---|
| Experimental protocol | Experimental | 24-week aquatic exercise training program Receives: Other: Aquatic exercise training program |
| Control protocol | No intervention | Maintain lifestyle routine as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Apnea-Hypopnea Index
Index which defines the OSAS severity. Is evaluated as events per hour by the polysomnography exam
Measured: Full-night sleep assessment: up to 8 hours
Secondary outcomes (5)
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.
Measured: Face to face interview for 8 minutes
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.
Measured: Face to face interview for 3 minutes
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.
Measured: Face to face interview for 6 minutes
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.
Measured: Face to face interview for 2 minutes
Oxygen consumption
This outcome will be assessed by a Cardiopulmonary exercise test in a cycle ergometer using Bruce Protocol.
Measured: Laboratory exam for 8-12 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2019
- Study startJan 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Experimental group: 24-week aquatic exercise training program Control group: maintain life style routine as usual
- Masking
- None (open label)
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Federal University of Paraíba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Bruno Teixeira Barbosa, Federal University of Paraíba
- Investigators
- Bruno T Barbosa, PhD Student, Principal investigator, Federal University of Paraiba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04120428
- Sponsor's protocol ID
- 05768912401
- Status last verified
- Oct 2019
- First submitted
- 7 Oct 2019
- Last updated
- 9 Oct 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The authors will make the data available based on journal guidelines selected to make the article published.
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 30477841Mendelson 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 29520251Sengul 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 19898884Kline 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 22131599Barbosa 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.
PubMed 28840546Tam 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
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 24-week Aquatic Exercise Training Program on Obstructive Sleep Apnea Severity in Elderly Women
- ClinicalTrials.gov ID
- NCT04120428
- Acronym / sponsor ID
- 05768912401
- Keywords
- Aquatic exercise, Obstructive sleep apnea syndrome, Sleep
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Federal University of ParaíbaUniversity, hospital or other
- Study start
- Jan 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Experimental group: 24-week aquatic exercise training program Control group: maintain life style routine as usual
| Arm | Type | Receives |
|---|---|---|
| Experimental protocol | Experimental | Other: Aquatic exercise training program24-week aquatic exercise training program |
| Control protocol | No intervention | –Maintain lifestyle routine as usual |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Cardiovascular, pulmonary or metabolic uncontrolled diseases
- Inability to perform the experimental protocol or keep the usual daily life
- Morbid obesity by body mass index
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aquatic exercise training programThe 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). | Other | Experimental protocol |
Primary outcome
Apnea-Hypopnea Index
Time frame: Full-night sleep assessment: up to 8 hours
Index which defines the OSAS severity. Is evaluated as events per hour by the polysomnography exam
5 secondary outcomes
Self-related sleep quality
Time frame: Face to face interview for 8 minutes
Daytime excessive somnolence
Time frame: Face to face interview for 3 minutes
Self-related quality of life
Time frame: Face to face interview for 6 minutes
Depressive symptoms
Time frame: Face to face interview for 2 minutes
Oxygen consumption
Time frame: Laboratory exam for 8-12 minutes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2019.
- Background: PubMed 30477841Bollens 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.
- Background: PubMed 29520251Mendelson 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.
- Background: PubMed 19898884Sengul 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.
- Background: PubMed 22131599Kline 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.
- Background: PubMed 28840546Barbosa 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.
- Background: PubMed 23794206Tam 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.
- Individual participant dataSharing planned: Yes. The authors will make the data available based on journal guidelines selected to make the article published.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bruno T Barbosa, PhD Student principal investigator
Federal University of Paraiba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aquatic exercise training program in people with Obstructive Sleep Apnea and Sleep-disordered Breathing, run by Federal University of Paraíba at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bruno T Barbosa, PhD Student (+5583998140500, brunobarbosacg@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Apnea-Hypopnea Index (time frame: Full-night sleep assessment: up to 8 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04120428, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2019.