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

Covid19 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04864132
• Other study ID #: 2015-KAEK-47-21-03
• Status: Completed
• Start date: May 27, 2021
• Est. completion date: November 15, 2022

Study information

• Verified date: November 2022
• Source: Biruni University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 15, 2022
• Est. primary completion date: October 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronavirus Infections
• Covid19

Intervention

Diagnostic Test:
• 6-minute walk test
This test assesses submaximal exercise capacity.
• Incremental shuttle walk test
This test assesses maximal exercise capacity.

Locations

Country	Name	City	State
Turkey	Biruni University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Biruni University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Submaximal and maximal exercise tests	The 6 minutes walking distance and incremental shuttle walk distance will be measured.	1 year
Secondary	Fatigue Severity Scale	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.	1 year
Secondary	Dyspnea-12 Scale	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.	1 year
Secondary	International Physical Activity Questionnaire-Short Form (IPAQ)	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.	1 year
Secondary	Forced expiratory volume in first second (FEV1) (predicted %)	The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.	1 year
Secondary	Peripheral muscle strength	The upper and lower extremity muscle strength will be measured using hand held dynamometer.	1 year
Secondary	Respiratory muscle strength	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.	1 year
Secondary	Forced vital capacity (FVC) (predicted %)	The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.	1 year
Secondary	FEV1/FVC (predicted %)	The acceptance criteria of the American Thoracic Society/European Respiratory Society will be used for spirometric measurements.	1 year