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

Obstructive Sleep Apnea Clinical Trial

Official title:

Effect Of Tele-Yoga On Aerobic Capacity, Respiratory Muscle Strength, And Cognitive Performance In Patients With Obstructive Sleep Apnea Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05517252
• Other study ID #: UskudarUn
• Status: Completed
• Phase: N/A
• Start date: September 1, 2022
• Est. completion date: December 15, 2022

Study information

• Verified date: February 2023
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 44
• Est. completion date: December 15, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Apnea
• Obstructive Sleep Apnea
• Sleep Apnea Syndromes
• Sleep Apnea, Obstructive

Intervention

Other:
• 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
• 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.

Locations

Country	Name	City	State
Turkey	Uskudar University Physiotherapy and Rehabilitation Application and Research Center	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Aerobic Capacity	Symptom-limited Cardiopulmonary Exercise Test (CPET) was performed on a treadmill to determine the aerobic capacity of the patients	12 week
Primary	Cognitive Performance	Corsi Block Tapping Test and Stroop test were performed to measure cognitive function.	12 week
Primary	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.	12 week
Secondary	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.	12 week
Secondary	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.	12 week
Secondary	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	12 week
Secondary	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.	12 week