COVID-19NCT05461391
The Effects of COVID-19 Infection on Respiratory Muscle Strength and Core Stabilization
An observational study of COVID-19 and Pandemic, COVID-19, run by Yeditepe University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19, Pandemic, COVID-19, Corona Virus Infection
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Mar 2022to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bezmialem Vakif University Dragos Hospital
Istanbul, Maltepe
About this study
Official title: 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.
Read the 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.
- Conditions
- COVID-19, Pandemic, COVID-19, Corona Virus Infection
- Keywords
- covid-19, coronavirus, respiratory physiotherapy, core stabilization
- Medical subject headings
- COVID-19, Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study Group | Participants who got COVID-19. | |
| Control Group | Healthy participants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
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.
Measured: 8 weeks
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.
Measured: 8 weeks
McGill Core Endurance Test
McGill Core Endurance Test consists of 4 different test positions. It assesses the core endurance of volunteers.
Measured: 8 weeks
Secondary outcomes (3)
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.
Measured: 8 weeks
Quality of Life Scale (SF36)
It was planned to evaluate the quality of life of the volunteers with SF36.
Measured: 8 weeks
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.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2022
- Study start15 Mar 2022
- Primary completion15 May 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yeditepe University
- Sponsor type
- University, hospital or other
- Collaborators
- Bezmialem Vakif University
- Responsible party
- Principal investigator, İldeniz Yalnız, Yeditepe University
- Investigators
- ildeniz yalnız, Study director, Bezmialem Vakif University Dragos Hospitalelif develi, Principal investigator, Yeditepe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05461391
- Sponsor's protocol ID
- yeditepe123
- Status last verified
- Aug 2023
- First submitted
- 12 Feb 2022
- Last updated
- 22 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 27121623Cavaggioni 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.
PubMed 26644685The 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.
PubMed 34594836Epidemiology 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.
PubMed 32064853Chhabra 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.
PubMed 26664177Lee 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.
PubMed 22018588FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.
PubMed 13003946Develi 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.
PubMed 33720873
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of COVID-19 Infection on Respiratory Muscle Strength and Core Stabilization in Healthy Individuals Who Exercise Regularly
- ClinicalTrials.gov ID
- NCT05461391
- Acronym / sponsor ID
- yeditepe123
- Conditions
- COVID-19, Pandemic, COVID-19, Corona Virus Infection
- Keywords
- covid-19, coronavirus, respiratory physiotherapy, core stabilization
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Yeditepe UniversityUniversity, hospital or other
- Collaborators
- Bezmialem Vakif University
- Study start
- 15 Mar 2022 (actual)
- Primary completion
- 15 May 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 18 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | – | –Participants who got COVID-19. |
| Control Group | – | –Healthy participants |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
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.
3 secondary outcomes
International Physical Activity Questionnaire - Short Form (IPAQ-SF)
Time frame: 8 weeks
Quality of Life Scale (SF36)
Time frame: 8 weeks
Dyspnea Scale
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2023.
- Background: PubMed 27121623Chiumello 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.
- Background: PubMed 26644685Cavaggioni 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.
- Background: PubMed 34594836The 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.
- Background: PubMed 32064853Epidemiology 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.
- Background: PubMed 26664177Chhabra 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.
- Background: PubMed 22018588Lee 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.
- Background: PubMed 13003946FLETCHER CM. The clinical diagnosis of pulmonary emphysema; an experimental study. Proc R Soc Med. 1952 Sep;45(9):577-84. No abstract available.
- Results publication: PubMed 33720873Develi 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.
- Individual participant dataSharing planned: No
Related trials for COVID-19
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
Active, not recruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Recruiting
Home-Based Exercise Tele-Rehabilitation After COVID-19
Post SARS-CoV2 (COVID-19)
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ildeniz yalnız study director
Bezmialem Vakif University Dragos Hospital
elif develi principal investigator
Yeditepe University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19 and Pandemic, COVID-19, run by Yeditepe University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulmonary Function Test (time frame: 8 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05461391, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2023.