- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04864132
The Investigation Of Exercise Capacity And Exercise-Induced Fatigue in Young Adults Who Survived From Coronavirus
November 15, 2022 updated by: Buket AKINCI, Biruni University
The effects of Coronavirus Disease (COVID-19), a multisystem disease, on the body system and functions are being investigated all over the world.
Examining the effect of exercise capacity, which is an important marker of cardiovascular risk in young individuals with COVID-19, will allow the planning of exercise and physical activity programs according to the needs of that specific population.
The objectives of this project are:(1) To compare the submaximal and maximal exercise capacity of young adults aged between 18-30 who have had COVID-19 with healthy individuals in the same age group (2) To determine the roles of muscle strength, respiratory functions, fatigue, dyspnea, and physical activity level on exercise capacity evaluated by two different tests in young adults survived from COVID-19.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The effects of COVID-19, a multisystem disease, on the body system and functions are being investigated worldwide.
For young adults, exercise capacity is vital in the workforce, cardiovascular risk factors and long-term health perception.
Determining exercise capacity, which is an essential indicator of cardiovascular risk in the long term, and determining the factors affecting exercise capacity in cases with COVID-19 will allow the planning of exercise and physical activity programs according to young people's needs.
The objectives of this project are:(1) To compare the submaximal and maximal exercise capacity of young adults aged between 18-30 who have had COVID-19 with healthy individuals in the same age group (2) To determine the roles of muscle strength, respiratory functions, fatigue, dyspnea, and physical activity level on exercise capacity evaluated by two different tests in young adults survived from COVID-19.
There is no study in the literature evaluating the exercise capacity and the factors affecting the prolonged COVID-19 symptoms for patients with COVID-19.
This project can provide objective evidence on this subject and includes controlled multi-directional measurement.
Study Type
Observational
Enrollment (Actual)
60
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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Istanbul, Turkey
- Biruni University
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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 30 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
The subjects who survived from COVID-19 aged between 18-30 and healthy individuals in the same age will be included in the project.
Description
Inclusion Criteria:
- For cases with COVID-19:
Confirmed COVID-19 infection - For healthy individuals of the same age group who have not had COVID-19: Individuals who have not been diagnosed with COVID-19 as of March 11, 2020 and who have not been in contact and risky according to the "Life Fits Into Home" application
- For all participants; Answering "No" to all questions in the Physical Activity Readiness Questionnaire.
Exclusion Criteria:
- Individuals with orthopedic or neurological disabilities that may interfere with exercise testing,
- Individuals with a fever> 38 ° C and / or resting blood pressure <90/60 mmHg or> 140/90 mmHg and/or oxygen saturation ≤95%,
- Individuals who have been involved in a physiotherapy and rehabilitation program within the last 3 months,
- Individuals with insufficient cooperation
- Individuals with blood coagulation disorders contraindicated for blood lactate analysis,
- Pregnant women or individuals with suspected pregnancy
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
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Subjects survived from COVID-19
The subjects who had confirmed COVID-19 infection aged between 18-30/years
|
This test assesses submaximal exercise capacity.
This test assesses maximal exercise capacity.
|
Subjects never had COVID-19
The subjects aged between 18-30/years who have not been diagnosed with COVID-19 as of March 11of 2020 and who have not been in contact and risky according to the "Life Fits Into Home" application
|
This test assesses submaximal exercise capacity.
This test assesses maximal exercise capacity.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Submaximal and maximal exercise tests
Time Frame: 1 year
|
The 6 minutes walking distance and incremental shuttle walk distance will be measured.
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1 year
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fatigue Severity Scale
Time Frame: 1 year
|
Fatigue levels will be measured with this scale.
This questionnaire contains nine statements that rate the severity of your fatigue symptoms and each question ranged from 1 to 7 based on how accurately it reflects the condition of the participant during the past week.
|
1 year
|
Dyspnea-12 Scale
Time Frame: 1 year
|
The dyspnea perception will be measured with this scale.There are 12 descriptor items on this scale ranging none (0), mild (1), moderate (2), or severe (3).
It provides an overall score for breathlessness severity that incorporates seven physical items and five affective items.
|
1 year
|
International Physical Activity Questionnaire-Short Form (IPAQ)
Time Frame: 1 year
|
The physical activity (PA) levels will be measured with this scale.The IPAQ-short is a seven-item measure of vigorous-intensity physical activity, moderate-intensity physical activity, walking, and sitting.
Participants reported physical activity frequency, duration, and total time spent sitting on a week day during the last week.
The total daily PA (MET-min day21) will be estimated by summing the multiplication of reported time within each item by a MET value specific to each category of PA and expressed as a daily average MET score, in accordance with the official IPAQ scoring protocol.
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1 year
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Forced expiratory volume in first second (FEV1) (predicted %)
Time Frame: 1 year
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The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.
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1 year
|
Peripheral muscle strength
Time Frame: 1 year
|
The upper and lower extremity muscle strength will be measured using hand held dynamometer.
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1 year
|
Respiratory muscle strength
Time Frame: 1 year
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Maximal inspiratory (MIP) and expiratory pressures (MEP) will be measured.
Maximal inspiratory pressure will be assessed from the residual volume and MEP will assessed a using the total lung capacity.
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1 year
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Forced vital capacity (FVC) (predicted %)
Time Frame: 1 year
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The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.
|
1 year
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FEV1/FVC (predicted %)
Time Frame: 1 year
|
The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.
|
1 year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Buket Akinci, Assoc. Prof., Biruni University
- Principal Investigator: Zeynep Hosbay, Assoc. Prof., Biruni University
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)
May 27, 2021
Primary Completion (ACTUAL)
October 15, 2022
Study Completion (ACTUAL)
November 15, 2022
Study Registration Dates
First Submitted
April 20, 2021
First Submitted That Met QC Criteria
April 24, 2021
First Posted (ACTUAL)
April 28, 2021
Study Record Updates
Last Update Posted (ACTUAL)
November 16, 2022
Last Update Submitted That Met QC Criteria
November 15, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2015-KAEK-47-21-03
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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