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

Sponsor
Biruni University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04864132
Collaborator
(none)
150
1
14.6
10.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: 6-minute walk test
  • Diagnostic Test: Incremental shuttle walk test

Detailed 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.

Study Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
150 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Investigation Of Exercise Capacity And Exercise-Induced Fatigue in Young Adults Who Survived From Coronavirus
Actual Study Start Date :
May 27, 2021
Anticipated Primary Completion Date :
Jul 30, 2022
Anticipated Study Completion Date :
Aug 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Subjects survived from COVID-19

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

Diagnostic Test: 6-minute walk test
This test assesses submaximal exercise capacity.

Diagnostic Test: Incremental shuttle walk test
This test assesses maximal exercise capacity.

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 test
This test assesses submaximal exercise capacity.

Diagnostic Test: Incremental shuttle walk test
This test assesses maximal exercise capacity.

Outcome Measures

Primary Outcome Measures

  1. Submaximal and maximal exercise tests [1 year]

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

Secondary Outcome Measures

  1. Fatigue Severity Scale [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 [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) [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 %) [1 year]

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

  5. Peripheral muscle strength [1 year]

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

  6. Respiratory muscle strength [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 %) [1 year]

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

  8. FEV1/FVC (predicted %) [1 year]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 30 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Biruni University Istanbul Turkey

Sponsors and Collaborators

  • Biruni University

Investigators

  • Study Chair: Buket Akinci, Assoc. Prof., Biruni University
  • Principal Investigator: Zeynep Hosbay, Assoc. Prof., Biruni University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Buket AKINCI, Associated Proffesor, Biruni University
ClinicalTrials.gov Identifier:
NCT04864132
Other Study ID Numbers:
  • 2015-KAEK-47-21-03
First Posted:
Apr 28, 2021
Last Update Posted:
Jun 27, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Buket AKINCI, Associated Proffesor, Biruni University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 27, 2022