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Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults (PEPICov)

Primary Purpose

Post COVID-19

Status
Active
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults
Sponsored by
Istanbul Arel University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Post COVID-19 focused on measuring COVID-19, respiration, physical capacity, sleep, muscle strength, 6-minute walking test

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Sites / Locations

  • Istanbul Arel University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

post COVID-19 group

healthy control group

Arm Description

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.

In this group cases, who were not infected with COVID-19 will be allocated.

Outcomes

Primary Outcome Measures

6-minute walk test
unit: meters

Secondary Outcome Measures

magnitude of muscle strength of upper and lower extremity
unit: Newtons
value of O2 saturation
unit: percent
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
spirometer testing
FEV1, FVC, FEV1/FVC values
pressure pain threshold
unit: Newtons/cm2
pain intensity
unit: millimeters (according to Visual Analog Scale)
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
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
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.
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.
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
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
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.

Full Information

First Posted
March 13, 2022
Last Updated
May 17, 2022
Sponsor
Istanbul Arel University
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1. Study Identification

Unique Protocol Identification Number
NCT05282043
Brief Title
Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults
Acronym
PEPICov
Official Title
Impacts of COVID-19 on Functional Capacity, Respiration, Pain, Depression, Sleep and Quality of Life on Young Adults
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 4, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul Arel University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Post COVID-19
Keywords
COVID-19, respiration, physical capacity, sleep, muscle strength, 6-minute walking test

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Non-Randomized
Enrollment
94 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
post COVID-19 group
Arm Type
Experimental
Arm Description
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.
Arm Title
healthy control group
Arm Type
Active Comparator
Arm Description
In this group cases, who were not infected with COVID-19 will be allocated.
Intervention Type
Other
Intervention Name(s)
Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults
Intervention Description
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.
Primary Outcome Measure Information:
Title
6-minute walk test
Description
unit: meters
Time Frame
up to 6 months
Secondary Outcome Measure Information:
Title
magnitude of muscle strength of upper and lower extremity
Description
unit: Newtons
Time Frame
up to 6 months
Title
value of O2 saturation
Description
unit: percent
Time Frame
up to 6 months
Title
Corbin's postural assessment
Description
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
Time Frame
up to 6 months
Title
spirometer testing
Description
FEV1, FVC, FEV1/FVC values
Time Frame
up to 6 months
Title
pressure pain threshold
Description
unit: Newtons/cm2
Time Frame
up to 6 months
Title
pain intensity
Description
unit: millimeters (according to Visual Analog Scale)
Time Frame
up to 6 months
Title
dyspnea severity
Description
(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
Time Frame
up to 6 months
Title
leg fatigue
Description
(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
Time Frame
up to 6 months
Title
general fatigue
Description
(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.
Time Frame
up to 6 months
Title
quality of life questionnaire
Description
(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.
Time Frame
up to 6 months
Title
depression severity
Description
(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
Time Frame
up to 6 months
Title
physical activity level (according to International Physical Activity Questionnaire/short form)
Description
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
Time Frame
up to 6 months
Title
quality of sleep
Description
(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.
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Facility Information:
Facility Name
Istanbul Arel University
City
Istanbul
State/Province
Zeytinburnu
ZIP/Postal Code
34010
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33393277
Citation
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.
Results Reference
result
PubMed Identifier
34510481
Citation
Lee 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 Reference
result
PubMed Identifier
34080125
Citation
Tanriverdi 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.
Results Reference
result

Learn more about this trial

Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults

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