Effect Of Tele-Yoga On Aerobic Capacity, Respiratory Muscle Strength, And Cognitive Performance In Patients With OSAS

NCT ID: NCT05517252

Last Updated: 2023-02-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 44 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-01
• Study Completion Date: 2022-12-15

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.

Conditions

Obstructive Sleep Apnea

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tele-Yoga Group

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.

Group Type: EXPERIMENTAL

Tele - Yoga

Intervention Type: OTHER

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

Control Group

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.

Group Type: EXPERIMENTAL

Thoracic Expansion Exercise

Intervention Type: OTHER

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.

Interventions

Tele - Yoga

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

Intervention Type: OTHER

Thoracic Expansion Exercise

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uskudar University

OTHER

Sponsor Role: lead

Responsible Party

FİLİZ EYÜBOĞLU

Lecturer

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Deniz Inal Ince, Phd

Role: STUDY_DIRECTOR

Hacettepe University

FİLİZ EYÜBOGLU, MSc

Role: PRINCIPAL_INVESTIGATOR

Uskudar University

Berna KARAMANCIOGLU

Role: PRINCIPAL_INVESTIGATOR

Uskudar University

Naciye VARDAR YAGLI, PhD

Role: PRINCIPAL_INVESTIGATOR

Hacettepe University

Defne KAYA UTLU, PhD

Role: PRINCIPAL_INVESTIGATOR

Uludag University

Orhan DALKILIC, PhD

Role: PRINCIPAL_INVESTIGATOR

Hisar Intercontinental Hospital

GOKSEL SOMAY, PhD

Role: PRINCIPAL_INVESTIGATOR

Intermed Ciftehavuzlar

Locations

Uskudar University Physiotherapy and Rehabilitation Application and Research Center

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

UskudarUn

Identifier Type: -

Identifier Source: org_study_id