Clinical trial NCT05282043: Pulmonary and Extrapulmonary Impacts of COVID-19 on Young Adults
Official title: Impacts of COVID-19 on Functional Capacity, Respiration, Pain, Depression, Sleep and Quality of Life on Young Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post COVID-19
Keywords: COVID-19
respiration
physical capacity
sleep
muscle strength
6-minute walking test
Lead sponsor: Istanbul Arel University
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: 6-minute walk test
timeFrame: up to 6 months
Secondary outcomes:
measure: magnitude of muscle strength of upper and lower extremity
timeFrame: up to 6 months
measure: value of O2 saturation
timeFrame: up to 6 months
measure: Corbin's postural assessment
timeFrame: up to 6 months
measure: spirometer testing
timeFrame: up to 6 months
measure: pressure pain threshold
timeFrame: up to 6 months
measure: pain intensity
timeFrame: up to 6 months
measure: dyspnea severity
timeFrame: up to 6 months
measure: leg fatigue
timeFrame: up to 6 months
measure: general fatigue
timeFrame: up to 6 months
measure: quality of life questionnaire
timeFrame: up to 6 months
measure: depression severity
timeFrame: up to 6 months
measure: physical activity level (according to International Physical Activity Questionnaire/short form)
timeFrame: up to 6 months
measure: quality of sleep
timeFrame: up to 6 months
Other outcomes:
measure: The post-COVID-19 functional status (PCFS) scale
timeFrame: up to 6 months
Locations:
city: Istanbul
country: Turkey
facility: Istanbul Arel University
state: Zeytinburnu
Study officials:
References:
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.
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.
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.