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

NCT05517252 | Completed

• 1 other identifier: UskudarUn
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Obstructive Sleep Apnea

Keywords

obstructive sleep apnea; yoga; aerobic capacity; respiratory muscle strength; neurocognitive performance

Outcome Measures

Primary Outcomes (3)

• Aerobic Capacity

  Symptom-limited Cardiopulmonary Exercise Test (CPET) was performed on a treadmill to determine the aerobic capacity of the patients

  12 week

• Cognitive Performance

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

  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.

  12 week

Secondary Outcomes (4)

• Functional Aerobic Capacity

  12 week

• Daytime Sleepiness

  12 week

• Sleep Quality

  12 week

• Health-Related Quality Of Life

  12 week

Study Arms (2)

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.

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.

Other: Thoracic Expansion Exercise

Interventions

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

Tele-Yoga Group

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.

Control Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Uskudar University Physiotherapy and Rehabilitation Application and Research Center

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Sleep Apnea, Obstructive

Condition Hierarchy (Ancestors)

Sleep Apnea Syndromes; Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Study Officials

• Deniz Inal Ince, Phd

  Hacettepe University

  STUDY DIRECTOR

• FİLİZ EYÜBOGLU, MSc

  Uskudar University

  PRINCIPAL INVESTIGATOR

• Berna KARAMANCIOGLU

  Uskudar University

  PRINCIPAL INVESTIGATOR

• Naciye VARDAR YAGLI, PhD

  Hacettepe University

  PRINCIPAL INVESTIGATOR

• Defne KAYA UTLU, PhD

  Uludag University

  PRINCIPAL INVESTIGATOR

• Orhan DALKILIC, PhD

  Hisar Intercontinental Hospital

  PRINCIPAL INVESTIGATOR

• GOKSEL SOMAY, PhD

  Intermed Ciftehavuzlar

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Model Details: Tele-Yoga and Control Group

Study Record Dates

• First Submitted: August 19, 2022
• First Posted: August 26, 2022
• Study Start: September 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: December 15, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)