Post COVID-19PEPICovNCT05282043
Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults
A study testing Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults in people with Post COVID-19, run by Istanbul Arel University at 1 site in Turkey (Türkiye).
Trial summary
When the literature search is conducted, it is seen that there are many studies examining the effects of COVID-19 disease on individuals in various disease groups (MS, stroke, Parkinson, COPD, asthma, etc.) and age groups (adult, geriatric, etc.). Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post COVID-19
- What is being tested?
- Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 4 Apr 2022to 5 Apr 2025
- Phase
- Interventional
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- volunteers who are aged between 18-45 years
- cases, who were infected with COVID-19 and had at least 12 weeks after diagnosis
- cases, who have no symptoms of COVID-19 such as fever, cough, ageusia, anosmia, diarrhea, arthralgia, myalgia, sore throat, headache, chest pain
Who cannot join
- those have any cardiac or pulmonary disease history
- those have diagnoses of any psychological disease (major depression, anxiety disorder, etc.)
- those have any neurological or orthopaedic disease which hinders participation in physical activity
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Istanbul Arel University
Istanbul, Zeytinburnu, 34010
About this study
Official title: Impacts of COVID-19 on Functional Capacity, Respiration, Pain, Depression, Sleep and Quality of Life on Young Adults
When the literature search is conducted, it is seen that there are many studies examining the effects of COVID-19 disease on individuals in various disease groups (MS, stroke, Parkinson, COPD, asthma, etc.) and age groups (adult, geriatric, etc.). However, it has been determined that there is no study examining the impacts of this disease on functional capacity, physical activity, pulmonary function, emotional state, sleep, and quality of life in healthy young adults. This study will reveal whether COVID-19 disease causes an effect on the mentioned parameters in young adults. The aim of recent study is to investigate functional capacity, respiration, pain, depression, sleep and quality of life in young adults post COVID-19. For this purpose, participants' upper extremity and lower extremity muscle strength, 6-minute walking distance, O2 saturation, posture evaluation, spirometric evaluation, pain threshold, pain intensity, dyspnea, and leg fatigue measurements will be recorded. In addition to these measurements, general fatigue, quality of life, depression, physical activity level, sleep quality parameters will be evaluated and the data obtained will be analyzed with appropriate statistical methods.
The goals of recent work,
- To determine whether COVID-19 disease causes a decrease in functional capacity and changes in respiratory parameters in young adults, as well as to determine whether there are effects such as pain, depression, decreased sleep and quality of life,
- To determine whether there are significant changes in the values of the relevant outcome measurements in all the mentioned parameters,
- As a result of these, to determine the effects of COVID-19 disease on these parameters in young adults with objective, measurable data and to guide researchers and clinicians who do/will conduct studies on the subject.
- Conditions
- Post COVID-19
- Being tested
- Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults
- Keywords
- COVID-19, respiration, physical capacity, sleep, muscle strength, 6-minute walking test
- Medical subject headings
- COVID-19, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young AdultsOther
Participants' upper extremity and lower extremity muscle strength, 6-minute walking distance, O2 saturation, posture evaluation, spirometric evaluation, pain threshold, pain intensity, dyspnea, and leg fatigue measurements will be recorded. In addition to these measurements, general fatigue, quality of life, depression, physical activity level, sleep quality parameters will be evaluated and the data obtained will be analyzed with appropriate statistical methods.
| Study group | Role | What they receive |
|---|---|---|
| post COVID-19 group | Experimental | In this group cases, who were infected with COVID-19 and had at least 12 weeks after diagnosis, will be allocated. Those should have no symptoms of COVID-19 such as fever, cough, ageusia, anosmia, diarrhea, arthralgia, myalgia, sore throat, headache, chest pain. Receives: Other: Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults |
| healthy control group | Active comparator | In this group cases, who were not infected with COVID-19 will be allocated. Receives: Other: Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults |
What is being measured
The primary outcome is the main question the study is designed to answer.
6-minute walk test
unit: meters
Measured: up to 6 months
Secondary outcomes (13)
magnitude of muscle strength of upper and lower extremity
unit: Newtons
Measured: up to 6 months
value of O2 saturation
unit: percent
Measured: up to 6 months
Corbin's postural assessment
This scale has a total score range between 0-18. Every subscore range refers to specific situations about posture. These are mentioned below:
0-4: Excellent 5-7: Very good 8-10: Good 11-13: Fair 14 or more: Poor
Measured: up to 6 months
spirometer testing
FEV1, FVC, FEV1/FVC values
Measured: up to 6 months
pressure pain threshold
unit: Newtons/cm2
Measured: up to 6 months
pain intensity
unit: millimeters (according to Visual Analog Scale)
Measured: up to 6 months
dyspnea severity
(according to Modified Borg Scale) This scale has a total score range between 0-10. Every subscore refers to specific situations about dyspnea. These are mentioned below: 0: No Exertion 0.5: Very very Slight
- Very Slight
- Slight
- Moderate
- Somewhat Severe
- Severe 6
7: Very Severe 8 9: Very very Severe 10: Maximal
Measured: up to 6 months
leg fatigue
(according to Modified Borg Scale) This scale has a total score range between 0-10. Every subscore refers to specific situations about leg fatigue. These are mentioned below: 0: No Exertion 0.5: Very very Slight
- Very Slight
- Slight
- Moderate
- Somewhat Severe
- Severe 6
7: Very Severe 8 9: Very very Severe 10: Maximal
Measured: up to 6 months
general fatigue
(according to Fatigue Severity Scale) This scale has a 9-item which measures the severity of fatigue and its effect on a person's activities and lifestyle in patients. Its minimum value is 9 and the maximum is 63. The higher the score indicates more severe fatigue and more impact on the person's activities.
Measured: up to 6 months
quality of life questionnaire
(according to Short Form-36) This form contains 36 questions. There are 8 different parameters of the questionnaire. These are mentioned below:
- Physical functioning
- Role limitations due to physical health
- Role limitations due to emotional problems
- Energy/fatigue
- Emotional well-being
- Social functioning
- Pain
- General health Every parameter has an average score that ranges between 0-100. Higher score indicates better situations that are specific to every parameter.
Measured: up to 6 months
depression severity
(according to Beck Depression Inventory) This inventory has a score range between 0-63. Certain score ranges refer to specific conditions. These are mentioned below: 1-10: normal 11-16: Mild mood disturbance 17-20: Borderline clinical depression 21-30: Moderate depression 31-40: Severe depression over 40: Extreme depression
Measured: up to 6 months
physical activity level (according to International Physical Activity Questionnaire/short form)
In this form, there are 4 different activities which have a certain MET level. The formule which is used for obtain a total score is presented below:
-MET level x minutes of activity x events per week
According to total score, a classification is established:
Inactive
- No activity OR
- Some activity but not enough to meet Categories 2 or 3. Minimally Active Any one of the following criterias
- 3 or more days of vigorous activity of at least 20 minutes per day
- 5 or more days of moderate intensity activity or walking of at least 30 minutes per day
- 5 or more days of any combination of walking, moderate-intensity or vigorous activities achieving a minimum of at least 600 MET-min/week.
HEPA active Any one of the following criterias
- Vigorous-intensity activity on at least 3 days and accumulating at least 1500 MET-minutes/week
- 7 or more days of any combination of walking, moderate-intensity or vigorous activities achieving a minimum of at least 3000 MET-minutes/week
Measured: up to 6 months
quality of sleep
(according to Pittsburgh Sleep Quality Index) This index has 7 components and overall scoring alters between 0-21 points. 0 point indicates no difficulty while 21 points indicate severe difficulties.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Mar 2022
- Study start4 Apr 2022
- Primary completion5 Apr 2025
- Study completion5 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Post 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Arel University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, NAZLI GÜNGÖR, Istanbul Arel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05282043
- Sponsor's protocol ID
- PEPICov
- Acronym
- PEPICov
- Status last verified
- Apr 2025
- First submitted
- 13 Mar 2022
- Last updated
- 30 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tuzun S, Keles A, Okutan D, Yildiran T, Palamar D. Assessment of musculoskeletal pain, fatigue and grip strength in hospitalized patients with COVID-19. Eur J Phys Rehabil Med. 2021 Aug;57(4):653-662. doi: 10.23736/S1973-9087.20.06563-6. Epub 2021 Jan 4.
PubMed 33393277Lee CC, Wu HJ, Chiou WB. Reminders of COVID-19 social distancing can intensify physical pain. Br J Soc Psychol. 2022 Apr;61(2):587-598. doi: 10.1111/bjso.12498. Epub 2021 Sep 12.
PubMed 34510481Tanriverdi A, Savci S, Kahraman BO, Ozpelit E. Extrapulmonary features of post-COVID-19 patients: muscle function, physical activity, mood, and sleep quality. Ir J Med Sci. 2022 Jun;191(3):969-975. doi: 10.1007/s11845-021-02667-3. Epub 2021 Jun 2.
PubMed 34080125
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impacts of COVID-19 on Functional Capacity, Respiration, Pain, Depression, Sleep and Quality of Life on Young Adults
- ClinicalTrials.gov ID
- NCT05282043
- Acronym / sponsor ID
- PEPICov / PEPICov
- Conditions
- Post COVID-19
- Keywords
- COVID-19, respiration, physical capacity, sleep, muscle strength, 6-minute walking test
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Istanbul Arel UniversityUniversity, hospital or other
- Study start
- 4 Apr 2022 (actual)
- Primary completion
- 5 Apr 2025 (actual)
- Study completion
- 5 Apr 2025 (actual)
- First posted
- 16 Mar 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.
When the literature search is conducted, it is seen that there are many studies examining the effects of COVID-19 disease on individuals in various disease groups (MS, stroke, Parkinson, COPD, asthma, etc.) and age groups (adult, geriatric, etc.). However, it has been determined that there is no study examining the impacts of this disease on functional capacity, physical activity, pulmonary function, emotional state, sleep, and quality of life in healthy young adults. This study will reveal whether COVID-19 disease causes an effect on the mentioned parameters in young adults. The aim of recent study is to investigate functional capacity, respiration, pain, depression, sleep and quality of life in young adults post COVID-19. For this purpose, participants' upper extremity and lower extremity muscle strength, 6-minute walking distance, O2 saturation, posture evaluation, spirometric evaluation, pain threshold, pain intensity, dyspnea, and leg fatigue measurements will be recorded. In addition to these measurements, general fatigue, quality of life, depression, physical activity level, sleep quality parameters will be evaluated and the data obtained will be analyzed with appropriate statistical methods.
The goals of recent work,
- To determine whether COVID-19 disease causes a decrease in functional capacity and changes in respiratory parameters in young adults, as well as to determine whether there are effects such as pain, depression, decreased sleep and quality of life,
- To determine whether there are significant changes in the values of the relevant outcome measurements in all the mentioned parameters,
- As a result of these, to determine the effects of COVID-19 disease on these parameters in young adults with objective, measurable data and to guide researchers and clinicians who do/will conduct studies on the subject.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| post COVID-19 group | Experimental | Other: Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young AdultsIn this group cases, who were infected with COVID-19 and had at least 12 weeks after diagnosis, will be allocated. Those should have no symptoms of COVID-19 such as fever, cough, ageusia, anosmia, diarrhea, arthralgia, myalgia, sore throat, headache, chest pain. |
| healthy control group | Active comparator | Other: Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young AdultsIn this group cases, who were not infected with COVID-19 will be allocated. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- volunteers who are aged between 18-45 years
- cases, who were infected with COVID-19 and had at least 12 weeks after diagnosis
- cases, who have no symptoms of COVID-19 such as fever, cough, ageusia, anosmia, diarrhea, arthralgia, myalgia, sore throat, headache, chest pain
Key exclusion criteria (3 listed)
- those have any cardiac or pulmonary disease history
- those have diagnoses of any psychological disease (major depression, anxiety disorder, etc.)
- those have any neurological or orthopaedic disease which hinders participation in physical activity
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 |
|---|---|---|
| Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young AdultsParticipants' upper extremity and lower extremity muscle strength, 6-minute walking distance, O2 saturation, posture evaluation, spirometric evaluation, pain threshold, pain intensity, dyspnea, and leg fatigue measurements will be recorded. In addition to these measurements, general fatigue, quality of life, depression, physical activity level, sleep quality parameters will be evaluated and the data obtained will be analyzed with appropriate statistical methods. | Other | healthy control group, post COVID-19 group |
Primary outcome
6-minute walk test
Time frame: up to 6 months
unit: meters
13 secondary outcomes
magnitude of muscle strength of upper and lower extremity
Time frame: up to 6 months
value of O2 saturation
Time frame: up to 6 months
Corbin's postural assessment
Time frame: up to 6 months
spirometer testing
Time frame: up to 6 months
pressure pain threshold
Time frame: up to 6 months
pain intensity
Time frame: up to 6 months
dyspnea severity
Time frame: up to 6 months
leg fatigue
Time frame: up to 6 months
general fatigue
Time frame: up to 6 months
quality of life questionnaire
Time frame: up to 6 months
depression severity
Time frame: up to 6 months
physical activity level (according to International Physical Activity Questionnaire/short form)
Time frame: up to 6 months
quality of sleep
Time frame: up to 6 months
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 30 Apr 2025.
- Results publication: PubMed 33393277Tuzun S, Keles A, Okutan D, Yildiran T, Palamar D. Assessment of musculoskeletal pain, fatigue and grip strength in hospitalized patients with COVID-19. Eur J Phys Rehabil Med. 2021 Aug;57(4):653-662. doi: 10.23736/S1973-9087.20.06563-6. Epub 2021 Jan 4.
- Results publication: PubMed 34510481Lee CC, Wu HJ, Chiou WB. Reminders of COVID-19 social distancing can intensify physical pain. Br J Soc Psychol. 2022 Apr;61(2):587-598. doi: 10.1111/bjso.12498. Epub 2021 Sep 12.
- Results publication: PubMed 34080125Tanriverdi A, Savci S, Kahraman BO, Ozpelit E. Extrapulmonary features of post-COVID-19 patients: muscle function, physical activity, mood, and sleep quality. Ir J Med Sci. 2022 Jun;191(3):969-975. doi: 10.1007/s11845-021-02667-3. Epub 2021 Jun 2.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults in people with Post COVID-19, run by Istanbul Arel 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 3 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 30 Apr 2025. 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?
6-minute walk test (time frame: up to 6 months). 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 NCT05282043, which also lists 3 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 30 Apr 2025.