Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults

Post COVID-19 Clinical Trial

— PEPICov  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05282043
• Other study ID #: PEPICov
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 4, 2022
• Est. completion date: September 30, 2024

Study information

• Verified date: June 2024
• Source: Istanbul Arel University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.). 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 94
• Est. completion date: September 30, 2024
• Est. primary completion date: August 30, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• COVID-19
• Post COVID-19

Intervention

Other:
• Evaluation of Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults
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.

Locations

Country	Name	City	State
Turkey	Istanbul Arel University	Istanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Arel University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	6-minute walk test	unit: meters	up to 6 months
Secondary	magnitude of muscle strength of upper and lower extremity	unit: Newtons	up to 6 months
Secondary	value of O2 saturation	unit: percent	up to 6 months
Secondary	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
Secondary	spirometer testing	FEV1, FVC, FEV1/FVC values	up to 6 months
Secondary	pressure pain threshold	unit: Newtons/cm2	up to 6 months
Secondary	pain intensity	unit: millimeters (according to Visual Analog Scale)	up to 6 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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