Clinical trial NCT05517252: Effect Of Tele-Yoga On Aerobic Capacity, Respiratory Muscle Strength, And Cognitive Performance In Patients With OSAS
Official title: Effect Of Tele-Yoga On Aerobic Capacity, Respiratory Muscle Strength, And Cognitive Performance In Patients With Obstructive Sleep Apnea Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Obstructive Sleep Apnea
Keywords: obstructive sleep apnea
yoga
aerobic capacity
respiratory muscle strength
neurocognitive performance
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2022-08-26
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Tele-Yoga and Control Group
Primary purpose: TREATMENT

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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,
* Uncontrolled hypertension,
* Trauma affecting the upper airways,
* Stroke or myocardial infarction in the last year

Primary outcomes:
measure: Aerobic Capacity
timeFrame: 12 week
measure: Cognitive Performance
timeFrame: 12 week
measure: Respiratory Muscle Strength
timeFrame: 12 week
Secondary outcomes:
measure: Functional Aerobic Capacity
timeFrame: 12 week
measure: Daytime Sleepiness
timeFrame: 12 week
measure: Sleep Quality
timeFrame: 12 week
measure: Health-Related Quality Of Life
timeFrame: 12 week
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Uskudar University Physiotherapy and Rehabilitation Application and Research Center
Study officials:
affiliation: Hacettepe University
name: Deniz Inal Ince, Phd
role: STUDY_DIRECTOR
affiliation: Uskudar University
name: FİLİZ EYÜBOGLU, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Uskudar University
name: Berna KARAMANCIOGLU
role: PRINCIPAL_INVESTIGATOR
affiliation: Hacettepe University
name: Naciye VARDAR YAGLI, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uludag University
name: Defne KAYA UTLU, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hisar Intercontinental Hospital
name: Orhan DALKILIC, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Intermed Ciftehavuzlar
name: GOKSEL SOMAY, PhD
role: PRINCIPAL_INVESTIGATOR
References: