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NCT Number: NCT05282043

Pulmonary and Extrapulmonary Impacts of COVID-19 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.

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Key information

Conditions

Post Covid-19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Pneumonia Pneumonia, Viral RNA Virus Infections Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Arel University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults

Other

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 outcomes

  1. 6-minute walk test

    Time frame: up to 6 months

    unit: meters

Secondary outcomes

  1. magnitude of muscle strength of upper and lower extremity

    Time frame: up to 6 months

    unit: Newtons

  2. value of O2 saturation

    Time frame: up to 6 months

    unit: percent

  3. Corbin's postural assessment

    Time frame: up to 6 months

    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

  4. spirometer testing

    Time frame: up to 6 months

    FEV1, FVC, FEV1/FVC values

  5. pressure pain threshold

    Time frame: up to 6 months

    unit: Newtons/cm2

  6. pain intensity

    Time frame: up to 6 months

    unit: millimeters (according to Visual Analog Scale)

  7. dyspnea severity

    Time frame: up to 6 months

    (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

  8. leg fatigue

    Time frame: up to 6 months

    (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

  9. general fatigue

    Time frame: up to 6 months

    (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.

  10. quality of life questionnaire

    Time frame: up to 6 months

    (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.

  11. depression severity

    Time frame: up to 6 months

    (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

  12. physical activity level (according to International Physical Activity Questionnaire/short form)

    Time frame: up to 6 months

    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

  13. quality of sleep

    Time frame: up to 6 months

    (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.

Other outcomes

  1. The post-COVID-19 functional status (PCFS) scale

    Time frame: up to 6 months

    The post-COVID-19 functional status (PCFS) scale focuses on relevant aspects of daily life during follow-up after the infection. The scale is intended to help users becoming aware of current functional limitations in COVID-19 patients, whether or not as a result of the specific infection, and to objectively determine this degree of disability. As such, the scale is not meant to replace other relevant instruments for measuring quality of life, tiredness or dyspnoea, but is developed to use as an additional tool for evaluating the ultimate consequences of COVID-19 on functional status. The scale is ordinal, has 6 steps ranging from 0 (no symptoms) to 5 (death, D), and covers the entire range of functional outcomes by focusing on limitations in usual duties/activities either at home or at work/study, as well as changes in lifestyle.

Sponsors and collaborators

Lead sponsor

Istanbul Arel University

Other

Registry information

Official study title

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

Acronym: PEPICov

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 16, 2022
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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