NCT04864132

Brief Summary

The effects of Coronavirus Disease (COVID-19), a multisystem disease, on the body system and functions are being investigated all over the world. Examining the effect of exercise capacity, which is an important marker of cardiovascular risk in young individuals with COVID-19, will allow the planning of exercise and physical activity programs according to the needs of that specific population. The objectives of this project are:(1) To compare the submaximal and maximal exercise capacity of young adults aged between 18-30 who have had COVID-19 with healthy individuals in the same age group (2) To determine the roles of muscle strength, respiratory functions, fatigue, dyspnea, and physical activity level on exercise capacity evaluated by two different tests in young adults survived from COVID-19.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2021

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

April 20, 2021

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 28, 2021

Completed
29 days until next milestone

Study Start

First participant enrolled

May 27, 2021

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2022

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2022

Completed
Last Updated

November 16, 2022

Status Verified

November 1, 2022

Enrollment Period

1.4 years

First QC Date

April 20, 2021

Last Update Submit

November 15, 2022

Conditions

Covid19

Keywords

coronavirusexercise capacity

Outcome Measures

Primary Outcomes (1)

  • Submaximal and maximal exercise tests

    The 6 minutes walking distance and incremental shuttle walk distance will be measured.

    1 year

Secondary Outcomes (8)

  • Fatigue Severity Scale

    1 year

  • Dyspnea-12 Scale

    1 year

  • International Physical Activity Questionnaire-Short Form (IPAQ)

    1 year

  • Forced expiratory volume in first second (FEV1) (predicted %)

    1 year

  • Peripheral muscle strength

    1 year

  • +3 more secondary outcomes

Study Arms (2)

Subjects survived from COVID-19

The subjects who had confirmed COVID-19 infection aged between 18-30/years

Diagnostic Test: 6-minute walk testDiagnostic Test: Incremental shuttle walk test

Subjects never had COVID-19

The subjects aged between 18-30/years who have not been diagnosed with COVID-19 as of March 11of 2020 and who have not been in contact and risky according to the "Life Fits Into Home" application

Diagnostic Test: 6-minute walk testDiagnostic Test: Incremental shuttle walk test

Interventions

6-minute walk testDIAGNOSTIC_TEST

This test assesses submaximal exercise capacity.

Subjects never had COVID-19Subjects survived from COVID-19
Incremental shuttle walk testDIAGNOSTIC_TEST

This test assesses maximal exercise capacity.

Subjects never had COVID-19Subjects survived from COVID-19

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

The subjects who survived from COVID-19 aged between 18-30 and healthy individuals in the same age will be included in the project.

You may qualify if:

  • For cases with COVID-19:
  • Confirmed COVID-19 infection - For healthy individuals of the same age group who have not had COVID-19: Individuals who have not been diagnosed with COVID-19 as of March 11, 2020 and who have not been in contact and risky according to the "Life Fits Into Home" application
  • \- For all participants; Answering "No" to all questions in the Physical Activity Readiness Questionnaire.

You may not qualify if:

  • Individuals with orthopedic or neurological disabilities that may interfere with exercise testing,
  • Individuals with a fever\> 38 ° C and / or resting blood pressure \<90/60 mmHg or\> 140/90 mmHg and/or oxygen saturation ≤95%,
  • Individuals who have been involved in a physiotherapy and rehabilitation program within the last 3 months,
  • Individuals with insufficient cooperation
  • Individuals with blood coagulation disorders contraindicated for blood lactate analysis,
  • Pregnant women or individuals with suspected pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biruni University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

COVID-19Coronavirus Infections

Interventions

Walk Test

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Exercise TestHeart Function TestsDiagnostic Techniques, CardiovascularDiagnostic Techniques and ProceduresDiagnosis

Study Officials

  • Buket Akinci, Assoc. Prof.

    Biruni University

    STUDY CHAIR

  • Zeynep Hosbay, Assoc. Prof.

    Biruni University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Target Duration
1 Year
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associated Proffesor

Study Record Dates

First Submitted

April 20, 2021

First Posted

April 28, 2021

Study Start

May 27, 2021

Primary Completion

October 15, 2022

Study Completion

November 15, 2022

Last Updated

November 16, 2022

Record last verified: 2022-11

Locations

TU(1)