search
Back to results

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

Primary Purpose

Obstructive Sleep Apnea

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Tele - Yoga
Thoracic Expansion Exercise
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Obstructive Sleep Apnea focused on measuring obstructive sleep apnea, yoga, aerobic capacity, respiratory muscle strength, neurocognitive performance

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uskudar University Physiotherapy and Rehabilitation Application and Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Tele-Yoga Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Aerobic Capacity
Symptom-limited Cardiopulmonary Exercise Test (CPET) was performed on a treadmill to determine the aerobic capacity of the patients
Cognitive Performance
Corsi Block Tapping Test and Stroop test were performed to measure cognitive function.
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.

Secondary Outcome Measures

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.
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.
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
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.

Full Information

First Posted
August 19, 2022
Last Updated
February 4, 2023
Sponsor
Uskudar University
search

1. Study Identification

Unique Protocol Identification Number
NCT05517252
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Actual)
Study Completion Date
December 15, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obstructive Sleep Apnea
Keywords
obstructive sleep apnea, yoga, aerobic capacity, respiratory muscle strength, neurocognitive performance

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Tele-Yoga and Control Group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
44 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tele-Yoga Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Tele - Yoga
Intervention Description
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
Intervention Name(s)
Thoracic Expansion Exercise
Intervention Description
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 Outcome Measure Information:
Title
Aerobic Capacity
Description
Symptom-limited Cardiopulmonary Exercise Test (CPET) was performed on a treadmill to determine the aerobic capacity of the patients
Time Frame
12 week
Title
Cognitive Performance
Description
Corsi Block Tapping Test and Stroop test were performed to measure cognitive function.
Time Frame
12 week
Title
Respiratory Muscle Strength
Description
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.
Time Frame
12 week
Secondary Outcome Measure Information:
Title
Functional Aerobic Capacity
Description
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.
Time Frame
12 week
Title
Daytime Sleepiness
Description
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.
Time Frame
12 week
Title
Sleep Quality
Description
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
Time Frame
12 week
Title
Health-Related Quality Of Life
Description
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.
Time Frame
12 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deniz Inal Ince, Phd
Organizational Affiliation
Hacettepe University
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
FİLİZ EYÜBOGLU, MSc
Organizational Affiliation
Uskudar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Berna KARAMANCIOGLU
Organizational Affiliation
Uskudar University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Naciye VARDAR YAGLI, PhD
Organizational Affiliation
Hacettepe University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Defne KAYA UTLU, PhD
Organizational Affiliation
Uludag University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Orhan DALKILIC, PhD
Organizational Affiliation
Hisar Intercontinental Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
GOKSEL SOMAY, PhD
Organizational Affiliation
Intermed Ciftehavuzlar
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uskudar University Physiotherapy and Rehabilitation Application and Research Center
City
Istanbul
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs