Persistent Dyspnea in Post COVID_19 and Pulmonary Function

February 7, 2022 updated by: Alaa Sayed Ali, Assiut University

Persistent Dyspnea in Post-COVID-19 Patients: Value of Cardiopulmonary Exercise Tests

COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (ICU)

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

COVID-19 has a high spread rate, millions of people have been infected around the world. Patients complained of different symptoms as fever, dry cough and fatigue which is mild in about 80% of cases, but the severity of the case may progress to develop a respiratory distress or respiratory failure, which may require the need for intensive care unit (ICU) Many patients with mild or severe COVID-19 do not make a full recovery and have a wide range of chronic symptoms for weeks or months after infection.

Post-COVID-19 syndrome is defined by persistent clinical signs and symptoms that appear while or after suffering COVID-19, persist for more than 12 weeks and cannot be explained by an alternative diagnosis.

Dyspnea is one of the most prevalent symptoms in post-covid-19 patients in up to 29% of patients with post COVID-19 syndrome.

Also, persistent dyspnea in post COVID-19 infection is frequent, it is so far, of unknown mechanism. Cardiopulmonary Exercise Test (CPET) is currently the gold standard technique in the differential diagnosis of dyspnea.

Cardiopulmonary exercise testing (CPET) is useful in the assessment of subjects with chronic lung conditions as it may help to: 1) recognize physiological factors limiting exercise (with or without the presence of psychogenic limiting factors); 2) identify these factors as potential therapeutic targets; 3) allow quantification of the level of impairment; 4) assess the effects of an intervention; and 5) provide prognostic information.

Study Type

Observational

Enrollment (Anticipated)

70

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients who are diagnosed as post covid_19 who were admittted to isolation unit of Assiut University Hospitals or visit the post covid_19 outpatient clinic

Description

Inclusion Criteria:

  • Confirmed or clinically and radiologically highly suspected Covid19-infection
  • Symptom duration at least 12 weeks following first occurrence of symptoms
  • Patients with dyspnea score 2, 3 and 4 on mMRC
  • No other disease that better could explain the symptoms (dyspnea) than Covid-19

Exclusion Criteria:

  • Age <18
  • pregnant women
  • terminally ill patients
  • active covid-19 infection
  • previous known severe pulmonary or heart disease
  • inability to perform pulmonary function or cardiopulmonary exercise tests.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dyspnea group

Patients with prior diagnosis of COVID-19 and present with persistent dyspnea after 12 weeks of occurrence of symptoms every patient in this group will undergo Cardiopulmonary exercise test (CPET) protocol: -

  1. As regard CPET protocol we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals.

  2. The following parameters observed:

    1. Metabolic response

      • Oxygen consumption VO2 (ml/ min):
      • P ETO2: Is the end-tidal O2 tension as measured from the exhaled air.
      • P ETCO2: Is the end-tidal CO2 tension as measured from the exhaled air. Normally decreased during exercise.
      • Anaerobic Threshold (AT): Is defined as the VO2 (in L/min) at which there is substantial transition to anaerobic metabolism to produce extra energy

    2. Ventilatory response

      • Minute ventilation :
      • Breathing reserve(BR): Breathing reserve = measured/predicted minute ventilation maximum
      • Tidal volume (VT):
      • Respiratory frequency (RF)
Diagnostic test: cardiopulmonary exercise tests

Spirometry

  • forced expiratory volume in 1 second (FEV1) % predicted,
  • forced vital capacity (FVC)% predicted,
  • forced expiratory volume in 1 second /forced vital capacity FEV1 /FVC
Other Names:
  • spirometry
Control group

Patients with prior diagnosis of COVID-19, fully recovered, without persistent dyspnea every patient in this group will undergo Cardiopulmonary exercise test (CPET) protocol: -

  1. As regard CPET protocol we prepared incremental treadmill exercise protocol in which the work rate increased at one-minute intervals.

  2. The following parameters observed:

    1. Metabolic response

      • Oxygen consumption VO2 (ml/ min):
      • P ETO2: Is the end-tidal O2 tension as measured from the exhaled air.
      • P ETCO2: Is the end-tidal CO2 tension as measured from the exhaled air. Normally decreased during exercise.
      • Anaerobic Threshold (AT): Is defined as the VO2 (in L/min) at which there is substantial transition to anaerobic metabolism to produce extra energy

    2. Ventilatory response

      • Minute ventilation :
      • Breathing reserve(BR): Breathing reserve = measured/predicted minute ventilation maximum
      • Tidal volume (VT):
      • Respiratory frequency (RF)
Diagnostic test: cardiopulmonary exercise tests

Spirometry

  • forced expiratory volume in 1 second (FEV1) % predicted,
  • forced vital capacity (FVC)% predicted,
  • forced expiratory volume in 1 second /forced vital capacity FEV1 /FVC
Other Names:
  • spirometry

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of 1. Aerobic capacity 2. Total Lung Capacity (TLC)
Time Frame: two years
Aerobic capacity measured as peak oxygen uptake Total lung capacity measured by spirometry
two years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of Walking capacity
Time Frame: two years
measured by 6 Minute Walk Test
two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

April 1, 2024

Study Registration Dates

First Submitted

February 6, 2022

First Submitted That Met QC Criteria

February 6, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 7, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • post COVID_19 and dyspnea

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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