- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05517252
Effect Of Tele-Yoga On Aerobic Capacity, Respiratory Muscle Strength, And Cognitive Performance In Patients With OSAS
February 4, 2023 updated by: FİLİZ EYÜBOĞLU, Uskudar University
Effect Of Tele-Yoga On Aerobic Capacity, Respiratory Muscle Strength, And Cognitive Performance In Patients With Obstructive Sleep Apnea Syndrome
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
44
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey
- Uskudar University Physiotherapy and Rehabilitation Application and Research Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: 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.
|
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
|
|
EXPERIMENTAL: 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.
|
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
12 week
|
|
Cognitive Performance
Time Frame: 12 week
|
Corsi Block Tapping Test and Stroop test were performed to measure cognitive function.
|
12 week
|
|
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.
|
12 week
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
12 week
|
|
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.
|
12 week
|
|
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
|
12 week
|
|
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.
|
12 week
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2022
Primary Completion (ACTUAL)
November 30, 2022
Study Completion (ACTUAL)
December 15, 2022
Study Registration Dates
First Submitted
August 19, 2022
First Submitted That Met QC Criteria
August 25, 2022
First Posted (ACTUAL)
August 26, 2022
Study Record Updates
Last Update Posted (ACTUAL)
February 8, 2023
Last Update Submitted That Met QC Criteria
February 4, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- UskudarUn
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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