Skip to main content
OpenTrials
Completed

NCT Number: NCT04864132

The Investigation Of Exercise Capacity And Exercise-Induced Fatigue in Young Adults Who Survived From Coronavirus

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Covid19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Biruni University

Istanbul, Turkey (Türkiye)

About this study

The effects of COVID-19, a multisystem disease, on the body system and functions are being investigated worldwide. For young adults, exercise capacity is vital in the workforce, cardiovascular risk factors and long-term health perception. Determining exercise capacity, which is an essential indicator of cardiovascular risk in the long term, and determining the factors affecting exercise capacity in cases with COVID-19 will allow the planning of exercise and physical activity programs according to young people's needs. 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. There is no study in the literature evaluating the exercise capacity and the factors affecting the prolonged COVID-19 symptoms for patients with COVID-19. This project can provide objective evidence on this subject and includes controlled multi-directional measurement.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • 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.

Exclusion criteria

  • 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

Treatment and study plan

6-minute walk test

Diagnostic Test

This test assesses submaximal exercise capacity.

Incremental shuttle walk test

Diagnostic Test

This test assesses maximal exercise capacity.

Primary outcomes

  1. Submaximal and maximal exercise tests

    Time frame: 1 year

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

Secondary outcomes

  1. Fatigue Severity Scale

    Time frame: 1 year

    Fatigue levels will be measured with this scale. This questionnaire contains nine statements that rate the severity of your fatigue symptoms and each question ranged from 1 to 7 based on how accurately it reflects the condition of the participant during the past week.

  2. Dyspnea-12 Scale

    Time frame: 1 year

    The dyspnea perception will be measured with this scale.There are 12 descriptor items on this scale ranging none (0), mild (1), moderate (2), or severe (3). It provides an overall score for breathlessness severity that incorporates seven physical items and five affective items.

  3. International Physical Activity Questionnaire-Short Form (IPAQ)

    Time frame: 1 year

    The physical activity (PA) levels will be measured with this scale.The IPAQ-short is a seven-item measure of vigorous-intensity physical activity, moderate-intensity physical activity, walking, and sitting. Participants reported physical activity frequency, duration, and total time spent sitting on a week day during the last week. The total daily PA (MET-min day21) will be estimated by summing the multiplication of reported time within each item by a MET value specific to each category of PA and expressed as a daily average MET score, in accordance with the official IPAQ scoring protocol.

  4. Forced expiratory volume in first second (FEV1) (predicted %)

    Time frame: 1 year

    The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.

  5. Peripheral muscle strength

    Time frame: 1 year

    The upper and lower extremity muscle strength will be measured using hand held dynamometer.

  6. Respiratory muscle strength

    Time frame: 1 year

    Maximal inspiratory (MIP) and expiratory pressures (MEP) will be measured. Maximal inspiratory pressure will be assessed from the residual volume and MEP will assessed a using the total lung capacity.

  7. Forced vital capacity (FVC) (predicted %)

    Time frame: 1 year

    The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.

  8. FEV1/FVC (predicted %)

    Time frame: 1 year

    The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.

Sponsors and collaborators

Lead sponsor

Biruni University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 28, 2021
Registry last updated
Nov 16, 2022

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.