Obstructive Sleep ApneaNCT05517252
Effect Of Tele-Yoga On Aerobic Capacity, Respiratory Muscle Strength, And Cognitive Performance In Patients With OSAS
A study testing Tele - Yoga and Thoracic Expansion Exercise in people with Obstructive Sleep Apnea, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial summary
OSAS has adverse effects on the functional capacity and quality of life of patients. This study aims to examine the impact of yoga on aerobic capacity, respiratory muscle strength, and cognitive performance in patients with OSAS. Patients will be randomly divided into two groups training (yoga) and control groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- Tele - Yoga and Thoracic Expansion Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 15 Dec 2022
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be diagnosed with clinically stable mild, moderate, and severe OSAS.
- Patients who had an internet network connection at home, had or could install a video telephony software program on their phone or computer
Who cannot join
- Subjects with a history of buccopharyngeal surgery,
- Concomitant severe orthopedic problems,
- Severe heart failure (New York Heart Association Classification III or IV, left ventricular ejection fraction <45%)
- Severe neurologic disease,
- Body mass index > 40 kg/m2,
- Major pulmonary dysfunction or diabetes,
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- Uncontrolled hypertension,
- Trauma affecting the upper airways,
- Stroke or myocardial infarction in the last year
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Uskudar University Physiotherapy and Rehabilitation Application and Research Center
Istanbul
About this study
Official title: Effect Of Tele-Yoga On Aerobic Capacity, Respiratory Muscle Strength, And Cognitive Performance In Patients With Obstructive Sleep Apnea Syndrome
OSAS has adverse effects on the functional capacity and quality of life of patients. This study aims to examine the impact of yoga on aerobic capacity, respiratory muscle strength, and cognitive performance in patients with OSAS. Patients will be randomly divided into two groups training (yoga) and control groups. The physical and demographic characteristics of the cases who signed the consent form will be recorded. Anthropometric measurements, circumference measurements, respiratory muscle strength (MIP and MEP), six-minute walking test (6MWT), and cardiopulmonary exercise test (CPET) will be performed. Corsi Blocks Touch Test, Continuous Performance Test, and Stroop Test will be applied to evaluate cognitive performance. The Pittsburg Sleep Index will be used for sleep quality, the Epworth Sleepiness Scale for sleepiness, and the SF-36 scales for health-related quality of life. Subjects with OSAS in the yoga group will be included in group-based yoga sessions of 60 minutes, 3 times a week for 12 weeks. Unilateral basal and apical thoracic expansion exercises will be taught to the patients with OSAS in the control group in the first session. They will be followed as a home program. At the end of the sixth and twelfth week, the evaluations will be made again and the result measurements will be taken.
Read the detailed description
Obstructive sleep apnea syndrome (OSAS) is a syndrome characterized by recurrent upper airway obstructions and accompanying a decrease in oxygen saturation during sleep. The prevalence of OSAS is increasing with the aging population and the obesity epidemic. OSAS has adverse effects on the functional capacity and quality of life of patients. This study aims to examine the effect of yoga on aerobic capacity, respiratory muscle strength, and cognitive performance in patients with OSAS. Patients will be randomly divided into two groups training (yoga) and control groups. The physical and demographic characteristics of the cases who signed the consent form will be recorded. Anthropometric measurements, circumference measurements, respiratory muscle strength (MIP and MEP), six-minute walking test (6MWT), and cardiopulmonary exercise test (CPET) will be performed. Corsi Blocks Touch Test, Continuous Performance Test, and Stroop Test will be applied to evaluate cognitive performance. The Pittsburg Sleep Index will be used for sleep quality, the Epworth Sleepiness Scale for sleepiness, and the SF-36 scales for health-related quality of life. Subjects with OSAS in the yoga group will be included in group-based yoga sessions of 60 minutes, 3 times a week for 12 weeks, in groups of 4 to 5 participants, synchronously in live sessions in an internet-based telerehabilitation environment. Yoga sessions will progress according to the protocol determined according to the weeks. Unilateral basal and apical thoracic expansion exercises will be taught to the patients with OSAS in the control group in the first session. They will be followed as a home program. At the end of the sixth and twelfth week, the evaluations will be made again and the result measurements will be taken. Then, the final measurements of the groups will be compared with statistical methods.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- Tele - Yoga, Thoracic Expansion Exercise
- Keywords
- obstructive sleep apnea, yoga, aerobic capacity, respiratory muscle strength, neurocognitive performance
- Medical subject headings
- Sleep Apnea, Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele - YogaOther
Telehealth interventions with Yoga are called Tele-yoga. Tele-Yoga aims to provide Yoga support to patients at low cost with the same quality and safety as face-to-face
Thoracic Expansion ExerciseOther
Thoracic expansion exercises are deep breathing exercises that focus on inspiration and help to loosen secretions on the lungs. Inspiration is active and usually combined with a three-second, end-inspiratory hold before a passive, relaxed and unforced expiration.
| Study group | Role | What they receive |
|---|---|---|
| Tele-Yoga Group | Experimental | OSAS patients in the Tele-Yoga group will be taken to group-based Hathastyle Tele-Yoga sessions of 60 minutes three times a week for 12 weeks, simultaneously in groups of 4-5 people, in an internet-based telerehabilitation environment. Receives: Other: Tele - Yoga |
| Control Group | Experimental | OSAS patients in the control group will be taught unilateral basal and apical chest expansion exercises in the first session and will be followed as a home program. 3-4 thoracic extension exercises and 1-2 breathing control will be repeated 10 times. The patient will be asked to do the home program four times a day and keep a diary for the home program. Receives: Other: Thoracic Expansion Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aerobic Capacity
Symptom-limited Cardiopulmonary Exercise Test (CPET) was performed on a treadmill to determine the aerobic capacity of the patients
Measured: 12 week
Cognitive Performance
Corsi Block Tapping Test and Stroop test were performed to measure cognitive function.
Measured: 12 week
Respiratory Muscle Strength
Respiratory muscle strength was measured using an electronic mouth pressure measuring device (Cosmed Ponyy Fx, Rome, Italy). Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) were measured.
Measured: 12 week
Secondary outcomes (4)
Functional Aerobic Capacity
The six-minute walk test (6MWT) was used to assess functional capacity. Patient was asked to walk for six minutes in a 30-meter corridor as fast as possible at his/her own walking pace. Before and after the test, heart rate and SpO2 were measured by pulse oximetry were recorded; blood pressure, and respiratory frequency were measured. At the end of the test, the distance walked by the subject for six minutes was recorded.
Measured: 12 week
Daytime Sleepiness
Epworth Sleepiness Scale (ESS), consisting of eight questions, was used to measure the general sleepiness of the subjects during the day. On the scale, answers for each question are scored between 0 and 3, and a total score is obtained.
Measured: 12 week
Sleep Quality
The Pittsburgh Sleep Quality Index (PSQI) is a scale consisting of 24 questions that provide detailed information about sleep quality and the type and severity of sleep disturbance in the last month
Measured: 12 week
Health-Related Quality Of Life
The Short Form Scale (SF-36) Quality of Life Questionnaire assessed overall health-related quality of life. This questionnaire consists of eight sections: physical functioning, physical role limitations, bodily pain, general health perception, energy/vitality, social functioning, emotional role limitations, and mental health.
Measured: 12 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2022
- Study start1 Sep 2022
- Primary completion30 Nov 2022
- Study completion15 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Tele-Yoga and Control Group
- Masking
- None (open label)
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, FİLİZ EYÜBOĞLU, Uskudar University
- Investigators
- Deniz Inal Ince, Phd, Study director, Hacettepe UniversityFİLİZ EYÜBOGLU, MSc, Principal investigator, Uskudar UniversityBerna KARAMANCIOGLU, Principal investigator, Uskudar UniversityNaciye VARDAR YAGLI, PhD, Principal investigator, Hacettepe UniversityDefne KAYA UTLU, PhD, Principal investigator, Uludag UniversityOrhan DALKILIC, PhD, Principal investigator, Hisar Intercontinental HospitalGOKSEL SOMAY, PhD, Principal investigator, Intermed Ciftehavuzlar
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05517252
- Sponsor's protocol ID
- UskudarUn
- Status last verified
- Feb 2023
- First submitted
- 19 Aug 2022
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Eyuboglu F, Inal-Ince D, Karamancioglu B, Vardar-Yagli N, Kaya-Utlu D, Dalkilic O, Somay G. Effect of tele-yoga on aerobic capacity, respiratory muscle strength, and cognitive performance in patients with obstructive sleep apnea syndrome. Heart Lung. 2023 Nov-Dec;62:157-167. doi: 10.1016/j.hrtlng.2023.07.005. Epub 2023 Aug 1.
PubMed 37536116
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect Of Tele-Yoga On Aerobic Capacity, Respiratory Muscle Strength, And Cognitive Performance In Patients With Obstructive Sleep Apnea Syndrome
- ClinicalTrials.gov ID
- NCT05517252
- Acronym / sponsor ID
- UskudarUn
- Conditions
- Obstructive Sleep Apnea
- Keywords
- obstructive sleep apnea, yoga, aerobic capacity, respiratory muscle strength, neurocognitive performance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 30 Nov 2022 (actual)
- Study completion
- 15 Dec 2022 (actual)
- First posted
- 26 Aug 2022 (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.
OSAS has adverse effects on the functional capacity and quality of life of patients. This study aims to examine the impact of yoga on aerobic capacity, respiratory muscle strength, and cognitive performance in patients with OSAS. Patients will be randomly divided into two groups training (yoga) and control groups. The physical and demographic characteristics of the cases who signed the consent form will be recorded. Anthropometric measurements, circumference measurements, respiratory muscle strength (MIP and MEP), six-minute walking test (6MWT), and cardiopulmonary exercise test (CPET) will be performed. Corsi Blocks Touch Test, Continuous Performance Test, and Stroop Test will be applied to evaluate cognitive performance. The Pittsburg Sleep Index will be used for sleep quality, the Epworth Sleepiness Scale for sleepiness, and the SF-36 scales for health-related quality of life. Subjects with OSAS in the yoga group will be included in group-based yoga sessions of 60 minutes, 3 times a week for 12 weeks. Unilateral basal and apical thoracic expansion exercises will be taught to the patients with OSAS in the control group in the first session. They will be followed as a home program. At the end of the sixth and twelfth week, the evaluations will be made again and the result measurements will be taken.
Detailed description
Obstructive sleep apnea syndrome (OSAS) is a syndrome characterized by recurrent upper airway obstructions and accompanying a decrease in oxygen saturation during sleep. The prevalence of OSAS is increasing with the aging population and the obesity epidemic. OSAS has adverse effects on the functional capacity and quality of life of patients. This study aims to examine the effect of yoga on aerobic capacity, respiratory muscle strength, and cognitive performance in patients with OSAS. Patients will be randomly divided into two groups training (yoga) and control groups. The physical and demographic characteristics of the cases who signed the consent form will be recorded. Anthropometric measurements, circumference measurements, respiratory muscle strength (MIP and MEP), six-minute walking test (6MWT), and cardiopulmonary exercise test (CPET) will be performed. Corsi Blocks Touch Test, Continuous Performance Test, and Stroop Test will be applied to evaluate cognitive performance. The Pittsburg Sleep Index will be used for sleep quality, the Epworth Sleepiness Scale for sleepiness, and the SF-36 scales for health-related quality of life. Subjects with OSAS in the yoga group will be included in group-based yoga sessions of 60 minutes, 3 times a week for 12 weeks, in groups of 4 to 5 participants, synchronously in live sessions in an internet-based telerehabilitation environment. Yoga sessions will progress according to the protocol determined according to the weeks. Unilateral basal and apical thoracic expansion exercises will be taught to the patients with OSAS in the control group in the first session. They will be followed as a home program. At the end of the sixth and twelfth week, the evaluations will be made again and the result measurements will be taken. Then, the final measurements of the groups will be compared with statistical methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Tele-Yoga and Control Group
| Arm | Type | Receives |
|---|---|---|
| Tele-Yoga Group | Experimental | Other: Tele - YogaOSAS patients in the Tele-Yoga group will be taken to group-based Hathastyle Tele-Yoga sessions of 60 minutes three times a week for 12 weeks, simultaneously in groups of 4-5 people, in an internet-based telerehabilitation environment. |
| Control Group | Experimental | Other: Thoracic Expansion ExerciseOSAS patients in the control group will be taught unilateral basal and apical chest expansion exercises in the first session and will be followed as a home program. 3-4 thoracic extension exercises and 1-2 breathing control will be repeated 10 times. The patient will be asked to do the home program four times a day and keep a diary for the home program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- To be diagnosed with clinically stable mild, moderate, and severe OSAS.
- Patients who had an internet network connection at home, had or could install a video telephony software program on their phone or computer
Key exclusion criteria (9 listed)
- Subjects with a history of buccopharyngeal surgery,
- Concomitant severe orthopedic problems,
- Severe heart failure (New York Heart Association Classification III or IV, left ventricular ejection fraction <45%)
- Severe neurologic disease,
- Body mass index > 40 kg/m2,
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 |
|---|---|---|
| Tele - YogaTelehealth interventions with Yoga are called Tele-yoga. Tele-Yoga aims to provide Yoga support to patients at low cost with the same quality and safety as face-to-face | Other | Tele-Yoga Group |
| Thoracic Expansion ExerciseThoracic expansion exercises are deep breathing exercises that focus on inspiration and help to loosen secretions on the lungs. Inspiration is active and usually combined with a three-second, end-inspiratory hold before a passive, relaxed and unforced expiration. | Other | Control Group |
Primary outcome
Aerobic Capacity
Time frame: 12 week
Symptom-limited Cardiopulmonary Exercise Test (CPET) was performed on a treadmill to determine the aerobic capacity of the patients
Cognitive Performance
Time frame: 12 week
Corsi Block Tapping Test and Stroop test were performed to measure cognitive function.
Respiratory Muscle Strength
Time frame: 12 week
Respiratory muscle strength was measured using an electronic mouth pressure measuring device (Cosmed Ponyy Fx, Rome, Italy). Maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) were measured.
4 secondary outcomes
Functional Aerobic Capacity
Time frame: 12 week
Daytime Sleepiness
Time frame: 12 week
Sleep Quality
Time frame: 12 week
Health-Related Quality Of Life
Time frame: 12 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Derived from this study: PubMed 37536116Eyuboglu F, Inal-Ince D, Karamancioglu B, Vardar-Yagli N, Kaya-Utlu D, Dalkilic O, Somay G. Effect of tele-yoga on aerobic capacity, respiratory muscle strength, and cognitive performance in patients with obstructive sleep apnea syndrome. Heart Lung. 2023 Nov-Dec;62:157-167. doi: 10.1016/j.hrtlng.2023.07.005. Epub 2023 Aug 1.
- Individual participant dataSharing planned: No
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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.
Deniz Inal Ince, Phd study director
Hacettepe University
FİLİZ EYÜBOGLU, MSc principal investigator
Uskudar University
Berna KARAMANCIOGLU principal investigator
Uskudar University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele - Yoga and Thoracic Expansion Exercise in people with Obstructive Sleep Apnea, run by Uskudar University at 1 site in Turkey (Türkiye).
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 2 inclusion and 9 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: finished, as of the sponsor's last update on 8 Feb 2023. 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 Turkey (Türkiye). 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Aerobic Capacity (time frame: 12 week). The study lists 3 primary outcomes in all. 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 NCT05517252, which also lists 1 linked publication.
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 8 Feb 2023.