NCT05282043

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
68

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 13, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 16, 2022

Completed
19 days until next milestone

Study Start

First participant enrolled

April 4, 2022

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 5, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 5, 2025

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

3 years

First QC Date

March 13, 2022

Last Update Submit

April 27, 2025

Conditions

Keywords

COVID-19respirationphysical capacitysleepmuscle strength6-minute walking test

Outcome Measures

Primary Outcomes (1)

  • 6-minute walk test

    unit: meters

    up to 6 months

Secondary Outcomes (13)

  • magnitude of muscle strength of upper and lower extremity

    up to 6 months

  • value of O2 saturation

    up to 6 months

  • Corbin's postural assessment

    up to 6 months

  • spirometer testing

    up to 6 months

  • pressure pain threshold

    up to 6 months

  • +8 more secondary outcomes

Other Outcomes (1)

  • The post-COVID-19 functional status (PCFS) scale

    up to 6 months

Study Arms (2)

post COVID-19 group

EXPERIMENTAL

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

healthy control group

ACTIVE COMPARATOR

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

Interventions

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.

healthy control grouppost COVID-19 group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Arel University

Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

  • 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.

  • 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.

MeSH Terms

Conditions

COVID-19Respiratory Aspiration

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesRespiration DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer, Department of Physiotherapy and Rehabilitation, Faculty of Health Sciences

Study Record Dates

First Submitted

March 13, 2022

First Posted

March 16, 2022

Study Start

April 4, 2022

Primary Completion

April 5, 2025

Study Completion

April 5, 2025

Last Updated

April 30, 2025

Record last verified: 2025-04

Data Sharing

IPD Sharing
Will not share

Locations