Covid19NCT04864132
The Investigation Of Exercise Capacity And Exercise-Induced Fatigue in Young Adults Who Survived From Coronavirus
An observational study of Covid19, run by Biruni University at 1 site in Turkey (Türkiye).
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- 6-minute walk test and Incremental shuttle walk test
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 May 2021to 15 Nov 2022
- How long will I take part?
- 1 Year
- 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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Covid19
- Being tested
- 6-minute walk test, Incremental shuttle walk test
- Keywords
- coronavirus, exercise capacity
- 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.
6-minute walk testDiagnostic test
This test assesses submaximal exercise capacity.
Incremental shuttle walk testDiagnostic test
This test assesses maximal exercise capacity.
| Study group | Role | What they receive |
|---|---|---|
| Subjects survived from COVID-19 | The subjects who had confirmed COVID-19 infection aged between 18-30/years Receives: Diagnostic Test: 6-minute walk test; Diagnostic Test: Incremental shuttle walk test | |
| 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 Receives: Diagnostic Test: 6-minute walk test; Diagnostic Test: Incremental shuttle walk test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Submaximal and maximal exercise tests
The 6 minutes walking distance and incremental shuttle walk distance will be measured.
Measured: 1 year
Secondary outcomes (8)
Fatigue Severity Scale
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.
Measured: 1 year
Dyspnea-12 Scale
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.
Measured: 1 year
International Physical Activity Questionnaire-Short Form (IPAQ)
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.
Measured: 1 year
Forced expiratory volume in first second (FEV1) (predicted %)
The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.
Measured: 1 year
Peripheral muscle strength
The upper and lower extremity muscle strength will be measured using hand held dynamometer.
Measured: 1 year
Respiratory muscle strength
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.
Measured: 1 year
Forced vital capacity (FVC) (predicted %)
The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.
Measured: 1 year
FEV1/FVC (predicted %)
The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2021
- Study start27 May 2021
- Primary completion15 Oct 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- More trials run by Biruni UniversityThe sponsor's other registered studies.
- 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
- Prospective
- Enrolment
- 60 participants (actual)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Biruni University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Buket AKINCI, Biruni University
- Investigators
- Buket Akinci, Assoc. Prof., Study chair, Biruni UniversityZeynep Hosbay, Assoc. Prof., Principal investigator, Biruni University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04864132
- Sponsor's protocol ID
- 2015-KAEK-47-21-03
- Status last verified
- Nov 2022
- First submitted
- 20 Apr 2021
- Last updated
- 16 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Investigation Of Exercise Capacity And Exercise-Induced Fatigue in Young Adults Who Survived From Coronavirus
- ClinicalTrials.gov ID
- NCT04864132
- Acronym / sponsor ID
- 2015-KAEK-47-21-03
- Conditions
- Covid19
- Keywords
- coronavirus, exercise capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Biruni UniversityUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 28 Apr 2021 (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.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Subjects survived from COVID-19 | – | Diagnostic Test: 6-minute walk test, Diagnostic Test: Incremental shuttle walk testThe subjects who had confirmed COVID-19 infection aged between 18-30/years |
| Subjects never had COVID-19 | – | Diagnostic Test: 6-minute walk test, Diagnostic Test: Incremental shuttle walk testThe 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 |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (6 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 6-minute walk testThis test assesses submaximal exercise capacity. | Diagnostic test | Subjects never had COVID-19, Subjects survived from COVID-19 |
| Incremental shuttle walk testThis test assesses maximal exercise capacity. | Diagnostic test | Subjects never had COVID-19, Subjects survived from COVID-19 |
Primary outcome
Submaximal and maximal exercise tests
Time frame: 1 year
The 6 minutes walking distance and incremental shuttle walk distance will be measured.
8 secondary outcomes
Fatigue Severity Scale
Time frame: 1 year
Dyspnea-12 Scale
Time frame: 1 year
International Physical Activity Questionnaire-Short Form (IPAQ)
Time frame: 1 year
Forced expiratory volume in first second (FEV1) (predicted %)
Time frame: 1 year
Peripheral muscle strength
Time frame: 1 year
Respiratory muscle strength
Time frame: 1 year
Forced vital capacity (FVC) (predicted %)
Time frame: 1 year
FEV1/FVC (predicted %)
Time frame: 1 year
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 16 Nov 2022.
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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.
Buket Akinci, Assoc. Prof. study chair
Biruni University
Zeynep Hosbay, Assoc. Prof. principal investigator
Biruni 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 Covid19, run by Biruni 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 6 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 16 Nov 2022. 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?
Submaximal and maximal exercise tests (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Nov 2022.