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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

Tracking Information
First Submitted Date June 26, 2020
First Posted Date June 30, 2020
Last Update Posted Date July 1, 2020
Actual Study Start Date June 25, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 26, 2020)
  • 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)
  • Sleep Quality [ Time Frame: 1 day ]
    The Pittsburgh Sleep Quality Index
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 26, 2020)
  • 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.
  • 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
  • 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.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 26, 2020)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title Physical Activity Level in Patients With OSAS During Covid-19 Pandemic
Official Title Evaluation of Physical Activity Level and Sleep Quality in Patients With Obstructive Sleep Apnea Syndrome During Covid-19 Pandemic
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.
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.
Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Obstructive Sleep Apnea-hypopnea Syndrome
Intervention Not Provided
Study Groups/Cohorts
  • OSAS PATIENTS
    mild, moderate and severe OSAS patients
  • HEALTHY INDIVIDUALS
    healthy individuals without chronic disease
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: June 26, 2020)
60
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date September 1, 2020   (Final data collection date for primary outcome measure)
Eligibility 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,
Sex/Gender
Sexes Eligible for Study: All
Ages 19 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Nurel Erturk, MsC +90505663-75-44 nrlbllr@gmail.com
Contact: Ebru Calik Kutukcu, PhD 0544 285-00-87 ebrucalk85@hotmail.com
Listed Location Countries Turkey
Removed Location Countries  
 
Administrative Information
NCT Number NCT04451993
Other Study ID Numbers GO 20/540
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party NUREL ERTURK, Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Study Sponsor Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Collaborators Not Provided
Investigators
Study Director: Naciye Vardar-Yagli, PhD Hacettepe University
Study Chair: Adem Celik, MD Ahi Evren Chest, Heart and Vascular Surgery Training and Research Hospital
PRS Account Ahi Evren Chest and Cardiovascular Surgery Education and Research Hospital
Verification Date June 2020