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Physical Activity Level in Patients With OSAS During Covid-19 Pandemic

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ClinicalTrials.gov Identifier: NCT04451993
Recruitment Status : Recruiting
First Posted : June 30, 2020
Last Update Posted : July 1, 2020
Sponsor:
Information provided by (Responsible Party):
NUREL ERTURK, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital

Brief Summary:
As long as the people stay at home because of the Covid 19 outbreak, the investigators assume that the sleep quality of OUAS patients, like everyone else, and the sleep quality of COVID-19 outbreak are reduced due to anxiety and anxiety in people. In addition, we assume that sleep quality and physical activity level are related to health literacy level and fear of movement (kinesiophobia). In this study; the investigators aimed to determine how patients are affected by this process by evaluating sleep quality, physical activity, fear of movement and health literacy in OSAS patients during our stay in the COVID-19 outbreak.

Condition or disease
Obstructive Sleep Apnea-hypopnea Syndrome

Detailed Description:
Research Ahi Evren Chest Cardiovascular Surgery Training Research Hospital will be performed in patients between the ages of 18-70 years, diagnosed with OSAS in the sleep laboratory. Sleep quality, physical activity, fear of movement and health literacy will be evaluated in OSAS patients. Evaluations will be made by phone In order for the study to be strong, it will be tried to reach the maximum patient that can be taken between June 2020 and October 2020.

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Study Type : Observational
Estimated Enrollment : 60 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Evaluation of Physical Activity Level and Sleep Quality in Patients With Obstructive Sleep Apnea Syndrome During Covid-19 Pandemic
Actual Study Start Date : June 25, 2020
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


Group/Cohort
OSAS PATIENTS
mild, moderate and severe OSAS patients
HEALTHY INDIVIDUALS
healthy individuals without chronic disease



Primary Outcome Measures :
  1. Physical Activity [ Time Frame: 1 day ]

    International Physical Activity Questionnaire/ In activity-specific scoring, walking under the heading of the fields is calculated by the sum of the moderate intensity activity and intensive activity in itself.

    From these calculations, a score is obtained in MET-minutes. There are 3 categories of physical activity level classification. Physical activity levels are classified as physically inactive (inactive), low level of physical activity (minimally active) and sufficient level of physical activity (very active)


  2. Sleep Quality [ Time Frame: 1 day ]
    The Pittsburgh Sleep Quality Index


Secondary Outcome Measures :
  1. Daytime Sleepiness [ Time Frame: 1 day ]
    In order to measure the general sleepiness of people during the day, it was evaluated with a standard questionnaire, which is defined as Epworth sleepiness scale (EUS) and consists of 8 questions. The answers for each question are scored between 0 and 3 and the total score is obtained. The score obtained above 10 in EUS has high sensitivity and specificity for daytime sleepiness.

  2. Fear of movement [ Time Frame: 1 day ]
    Tampa Kinesiophobia Scale (TKS)The person gets a total score between 17-68. The high score on the scale indicates that kinesiophobia is also high

  3. Health literacy [ Time Frame: 1 day ]

    Translated into Turkish TURKEY health literacy SCALE-32 (Tsoy-32) will be used. It was used to evaluate the literacy rates of individuals over the age of 15.

    0 indicates the lowest health literacy and 50 indicates the highest health literacy.



Other Outcome Measures:
  1. Circadian rhythm evaluation [ Time Frame: 1 day ]
    In the human circadian rhythm, the Morning Morning-Evening Survey (SAA) form was used, which determined morning and evening types.



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Ages Eligible for Study:   19 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients and healthy individuals between 18-70 years old, who are diagnosed with OSAS in the sleep lab at the Ahi Evren Chest, Heart and Vascular Surgery Training and Research Hospital, and whose local language is Turkish will be included in the study.
Criteria

Inclusion Criteria:

  1. Having been diagnosed with OSAS and disease severity determined,
  2. Being between the age of 19-70,
  3. Body mass index <40 kg / m2
  4. Volunteering to participate in the research,
  5. Not having a mental problem that will hinder the cooperation.

Exclusion Criteria:

  1. To have advanced orthopedic, neurological and cardiovascular disease,
  2. Having a cognitive problem,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04451993


Contacts
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Contact: Nurel Erturk, MsC +90505663-75-44 nrlbllr@gmail.com
Contact: Ebru Calik Kutukcu, PhD 0544 285-00-87 ebrucalk85@hotmail.com

Locations
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Turkey
Trabzon Ahi Evren Thoracic and Cardiovascular Surgery Training and Research Hospital Recruiting
Trabzon, Turkey
Contact: Nurel Erturk, MsC    +905056637544    nrlbllr@gmail.com   
Sub-Investigator: Adem Celik, MD         
Principal Investigator: Ebru Calik-Kutukcu, PhD         
Sub-Investigator: Naciye Vardar-Yagli, PhD         
Sponsors and Collaborators
Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Investigators
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Study Director: Naciye Vardar-Yagli, PhD Hacettepe University
Study Chair: Adem Celik, MD Ahi Evren Chest, Heart and Vascular Surgery Training and Research Hospital
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Responsible Party: NUREL ERTURK, Phd student, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
ClinicalTrials.gov Identifier: NCT04451993    
Other Study ID Numbers: GO 20/540
First Posted: June 30, 2020    Key Record Dates
Last Update Posted: July 1, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by NUREL ERTURK, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital:
physical activity
COVID-19
sleep quality
Additional relevant MeSH terms:
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Sleep Apnea Syndromes
Sleep Apnea, Obstructive
Syndrome
Disease
Pathologic Processes
Apnea
Respiration Disorders
Respiratory Tract Diseases
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases