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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05461391
Other study ID # yeditepe123
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 15, 2022
Est. completion date June 30, 2022

Study information

Verified date August 2023
Source Yeditepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

World Health Organization (WHO) Novel-19 Corrosion Disease (COVID) in 2019 without being used by a pathway caused by the SARS-CoV-2 virus. After the acute period in COVID-19 patients, muscle weakness may continue in breathing, weakness, and training. The effects on core stabilization, pulmonary functions, respiratory muscle strength, physical activity scores and quality of life in healthy adults who do not have COVID-19 who do regular exercise may be higher than in healthy adults who do regular exercise with COVID-19.


Description:

The type of our study was planned as Case-Control. 50 exercises will be included in our study. The first COVID-19 (n= 25) is healthy, and the second group will come from the successful group without COVID-19 (n=25). Between February and April, a student will accept participating in the clinic at Bezmialem Foundation University. After being informed about it, the attached form will be signed. In addition, participants will be asked to fill in our attached document, including demographic and clinical studies, in a face-to-face interview. All body exercises, breathing muscle test, six-minute walking test, McGill core endurance test, short-form test, and quality of life test were planned in our two groups. The results of these tests will be evaluated by testing and checking.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date June 30, 2022
Est. primary completion date May 15, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 50 Years
Eligibility Inclusion Criteria: 1. To be between the ages of 18-50, 2. Volunteering to participate in the research, 3. Those who have done aerobic exercise at least three days a week in the last three months Exclusion Criteria: 1. Neurological deficits in the upper or lower extremities, 2. Fractures or orthopedic problems in the upper or lower extremities, 3. Cardiovascular diseases that prevent rehabilitation, 4. Systematic rheumatic disease (rheumatoid arthritis, ankylosing spondylitis), 5. History of surgery in the last three months, 6. Patients with spine problems, 7. Smokers, 8. Patients with chronic respiratory problems.

Study Design


Locations

Country Name City State
Turkey Bezmialem Vakif University Dragos Hospital Istanbul Maltepe

Sponsors (2)

Lead Sponsor Collaborator
Yeditepe University Bezmialem Vakif University

Country where clinical trial is conducted

Turkey, 

References & Publications (8)

Cavaggioni L, Ongaro L, Zannin E, Iaia FM, Alberti G. Effects of different core exercises on respiratory parameters and abdominal strength. J Phys Ther Sci. 2015 Oct;27(10):3249-53. doi: 10.1589/jpts.27.3249. Epub 2015 Oct 30. — View Citation

Chhabra SK. Clinical application of spirometry in asthma: Why, when and how often? Lung India. 2015 Nov-Dec;32(6):635-7. doi: 10.4103/0970-2113.168139. No abstract available. — View Citation

Chiumello D, Coppola S, Froio S, Gotti M. What's Next After ARDS: Long-Term Outcomes. Respir Care. 2016 May;61(5):689-99. doi: 10.4187/respcare.04644. — View Citation

Develi E, Subasi F, Aslan GK, Bingol Z. The effects of core stabilization training on dynamic balance and pulmonary parameters in patients with asthma. J Back Musculoskelet Rehabil. 2021;34(4):639-648. doi: 10.3233/BMR-191803. — View Citation

Epidemiology Working Group for NCIP Epidemic Response, Chinese Center for Disease Control and Prevention. [The epidemiological characteristics of an outbreak of 2019 novel coronavirus diseases (COVID-19) in China]. Zhonghua Liu Xing Bing Xue Za Zhi. 2020 Feb 10;41(2):145-151. doi: 10.3760/cma.j.issn.0254-6450.2020.02.003. Chinese. — View Citation

FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available. — View Citation

Lee PH, Macfarlane DJ, Lam TH, Stewart SM. Validity of the International Physical Activity Questionnaire Short Form (IPAQ-SF): a systematic review. Int J Behav Nutr Phys Act. 2011 Oct 21;8:115. doi: 10.1186/1479-5868-8-115. — View Citation

The Novel Coronavirus Pneumonia Emergency Response Epidemiology Team. The Epidemiological Characteristics of an Outbreak of 2019 Novel Coronavirus Diseases (COVID-19) - China, 2020. China CDC Wkly. 2020 Feb 21;2(8):113-122. No abstract available. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Pulmonary Function Test Medical International Research Spirodoc® Spiro spirometry will evaluate the respiratory functions of Italian brand volunteers. Lung function tests can determine both expected values and deviations of lung volumes. Spirometry has been used for over 150 years. Spirometry tests objectively evaluate both inspiratory and expiratory patients. The test will be repeated three times, and the best values will be recorded before and after the interventions. 8 weeks
Primary Respiratory Muscle Strength Mikro Medical Micro RPM is aimed to measure Maximal Inspiratory Pressure (MIP) and Maximal Expiratory Pressure (MEP) values. During the application, maximum effort is requested, and the patient will be shown the test beforehand. During the measurement of MIP and MEP, it is closed with a nose clip, and after a deep breath, volunteers will be asked to give a maximum exhale for 1 to 3 seconds. 8 weeks
Primary Six Minute Walk Test (6MWT) The 6MWT is a test that patients most commonly use, is valid, inexpensive, popular, easy to tolerate, easy to use, has minimal technological resources, and shows daily activity compared to other walking tests. They will be asked to walk at the same speed for 6 minutes, but not to run, on a 30-meter straight corridor. The volunteers' distance walked in 6 minutes will be calculated and evaluated. 8 weeks
Primary McGill Core Endurance Test McGill Core Endurance Test consists of 4 different test positions. It assesses the core endurance of volunteers. 8 weeks
Secondary International Physical Activity Questionnaire - Short Form (IPAQ-SF) The IPAQ is the most widely used physical activity questionnaire to describe young and middle-aged adults (15-69 years) participation in physical activity. IPAQ-SF (short form) provides individual results for walking, moderate-intensity, and vigorous-intensity activity scores. The three physical activities' duration (in minutes) and frequency (in days) give the total score. Scores used for Mean Metabolic Task Equivalent (MET) values, total physical activity MET-minutes/week = Total walking + Moderate + Vigorous MET minutes/week scores. Survey questions will be asked to the participants face to face by the researcher, and the answers will be recorded. 8 weeks
Secondary Quality of Life Scale (SF36) It was planned to evaluate the quality of life of the volunteers with SF36. 8 weeks
Secondary Dyspnea Scale The Modified Medical Research Council Scale (MMRC) is used to investigate the severity of dyspnea during activity in people with and without the disease. The MMRC is a five-item scale based on various activities that cause shortness of breath. Volunteers easily mark the activity level that causes dyspnea on the scale. The story of dyspnea in patients is graded from the "0" point, and the "0" point indicates the absence of dyspnea. The survey questions will be asked to the participants face to face by the researcher, and the answers will be recorded. 8 weeks
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