- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05461391
The Effects of COVID-19 Infection on Respiratory Muscle Strength and Core Stabilization
August 17, 2023 updated by: İldeniz Yalnız, Yeditepe University
The Effects of COVID-19 Infection on Respiratory Muscle Strength and Core Stabilization in Healthy Individuals Who Exercise Regularly
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.
Study Overview
Status
Completed
Conditions
Detailed 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.
Study Type
Observational
Enrollment (Actual)
50
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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Maltepe
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Istanbul, Maltepe, Turkey
- Bezmialem Vakif University Dragos Hospital
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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 to 50 years (Adult)
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
Study Population
Data will be evaluated in healthy adult volunteers who agreed to participate in the clinical study at Bezmialem Vakıf University Dragos Hospital between February and April.
Description
Inclusion Criteria:
- To be between the ages of 18-50,
- Volunteering to participate in the research,
- Those who have done aerobic exercise at least three days a week in the last three months
Exclusion Criteria:
- Neurological deficits in the upper or lower extremities,
- Fractures or orthopedic problems in the upper or lower extremities,
- Cardiovascular diseases that prevent rehabilitation,
- Systematic rheumatic disease (rheumatoid arthritis, ankylosing spondylitis),
- History of surgery in the last three months,
- Patients with spine problems,
- Smokers,
- Patients with chronic respiratory problems.
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
- Observational Models: Case-Control
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
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Study Group
Participants who got COVID-19.
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Control Group
Healthy participants
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pulmonary Function Test
Time Frame: 8 weeks
|
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.
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8 weeks
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Respiratory Muscle Strength
Time Frame: 8 weeks
|
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.
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8 weeks
|
Six Minute Walk Test (6MWT)
Time Frame: 8 weeks
|
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.
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8 weeks
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McGill Core Endurance Test
Time Frame: 8 weeks
|
McGill Core Endurance Test consists of 4 different test positions.
It assesses the core endurance of volunteers.
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8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time Frame: 8 weeks
|
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.
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8 weeks
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Dyspnea Scale
Time Frame: 8 weeks
|
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.
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8 weeks
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Quality of Life Scale (SF36)
Time Frame: 8 weeks
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It was planned to evaluate the quality of life of the volunteers with SF36.
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8 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Study Director: ildeniz yalnız, Bezmialem Vakif University Dragos Hospital
- Principal Investigator: elif develi, Yeditepe University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.
- 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.
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)
March 15, 2022
Primary Completion (Actual)
May 15, 2022
Study Completion (Actual)
June 30, 2022
Study Registration Dates
First Submitted
February 12, 2022
First Submitted That Met QC Criteria
July 14, 2022
First Posted (Actual)
July 18, 2022
Study Record Updates
Last Update Posted (Actual)
August 22, 2023
Last Update Submitted That Met QC Criteria
August 17, 2023
Last Verified
August 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- yeditepe123
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
product manufactured in and exported from the U.S.
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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