Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults

Study Overview
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Brief Summary
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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.

Official Title
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Impacts of COVID-19 on Functional Capacity, Respiration, Pain, Depression, Sleep and Quality of Life on Young Adults

Conditions
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Post COVID-19

Intervention / Treatment
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* Other: Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: post COVID-19 group<br>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. | Other: Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults<br>* 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.<br>|
| Active Comparator: healthy control group<br>In this group cases, who were not infected with COVID-19 will be allocated. | Other: Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-minute walk test | unit: meters | up to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| magnitude of muscle strength of upper and lower extremity | unit: Newtons | up to 6 months | 
| value of O2 saturation | unit: percent | 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 | up to 6 months | 
| spirometer testing | FEV1, FVC, FEV1/FVC values | up to 6 months | 
| pressure pain threshold | unit: Newtons/cm2 | up to 6 months | 
| pain intensity | unit: millimeters (according to Visual Analog Scale) | 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 | 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 | 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. | 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. | 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 | 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 | 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. | up to 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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COVID-19, respiration, physical capacity, sleep, muscle strength, 6-minute walking test