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Completed

NCT Number: NCT05517252

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uskudar University Physiotherapy and Rehabilitation Application and Research Center

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tele - Yoga

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

Thoracic Expansion Exercise

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.

Primary outcomes

  1. 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

  2. Cognitive Performance

    Time frame: 12 week

    Corsi Block Tapping Test and Stroop test were performed to measure cognitive function.

  3. 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.

Secondary outcomes

  1. Functional Aerobic Capacity

    Time frame: 12 week

    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.

  2. Daytime Sleepiness

    Time frame: 12 week

    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.

  3. Sleep Quality

    Time frame: 12 week

    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

  4. Health-Related Quality Of Life

    Time frame: 12 week

    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.

Sponsors and collaborators

Lead sponsor

Uskudar University

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Aug 26, 2022
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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