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Functional Capacity in Patients Post Mild COVID-19

Primary Purpose

COVID-19

Status
Recruiting
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
Cardiopulmonary exercise test (CPET)
Sponsored by
Rambam Health Care Campus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for COVID-19 focused on measuring Cardiopulmonary Exercise Testing, COVID-19, Exertional dyspnea

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients recovering from COVID-19 with a documented infection with severe acute respiratory syndrome coronavirus-2 and cognitive ability to sign informed consent and physical ability to participate in exercise tests.

Exclusion Criteria:

  • Patients with severe pulmonary, cardiac disease prior to COVID-19, pregnant women, and patients with active infection or cancer.

Sites / Locations

  • Rambam Medical CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cardiopulmonary exercise test (CPET)

Arm Description

Cardiopulmonary exercise testing (CPET) using a Quark CPET metabolic cart (Rome, Italy) according to American Thoracic Society (ATS) guidelines. A symptom-limited test on a treadmill will be performed, using incremental ramp Bruce protocol up to exhaustion. Patients who will not be able to perform the test on a treadmill will be tested on a cycle ergometer beginning with a no-resistance warm-up lasting 2-3 minutes, followed by incrementing resistance (8-30 Watts/minute) adapted to the patient's functional capacities according to the examiner's free judgment, up to exhaustion.

Outcomes

Primary Outcome Measures

Exercise capacity
Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)

Secondary Outcome Measures

Echocardiography
Left ventricle shortening and ejection fraction, as well as possible cardiac structural or hemodynamic abnormalities will be evaluated by trans-thoracic echocardiography (iE33, Philips).
Six minute walk test
The distance gained after six minute of habitual walking.
Spirometry
Pulmonary function as assessed by spirometry.

Full Information

First Posted
April 7, 2022
Last Updated
April 10, 2022
Sponsor
Rambam Health Care Campus
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1. Study Identification

Unique Protocol Identification Number
NCT05323760
Brief Title
Functional Capacity in Patients Post Mild COVID-19
Official Title
Functional Capacity in Patients Who Recovered From Mild COVID-19 With Exertional Dyspnea.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
September 9, 2020 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rambam Health Care Campus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
Patients recovered from mild coronavirus 2019 (COVID-19) disease without pulmonary involvement may experience long-term physical impairment and dyspnea. The investigators aim to characterize physiologic limitations in patients who recovered from mild COVID-19. Methods: Pulmonary function tests (PFTs), 6-minute walk test (6MWT), echocardiography and cardiopulmonary exercise test (CPET) will be completed in patients recovered from mild COVID-19 disease with prolonged dyspnea (Subgroup "A") and compared to patients recovered from moderate/severe COVID-19 (subgroup "B") and to non-COVID-19 patients with unexplained dyspnea (subgroup "C").
Detailed Description
Infection with severe acute respiratory syndrome coronavirus-2 leads to severe disease requiring hospitalization in 20% of the cases. Respiratory failure from severe acute respiratory syndrome coronavirus-2 infection can range from mild pneumonia and hypoxia to life threatening hypoxia secondary to severe acute respiratory distress syndrome requiring intensive care unit and mechanical ventilation in about 12-24% of the hospitalized patients. Most patients are discharged with minimal or no long-term oxygen therapy while others are discharged with ongoing respiratory symptoms and long-term oxygen therapy. In the longer term, there is a significant concern that severe coronavirus disease 2019 can lead to organizing pneumonia and severe acute lung injury with evolution to widespread fibrotic changes as seen in fatal cases of coronavirus disease showing pulmonary fibrosis at autopsy. Studies in severe acute respiratory syndrome survivors, another corona virus infection, showed persistent and significant impairment of exercise capacity and health status over 24 months based on PFTs, 6-minute walk test and health questionnaire. Infection with respiratory syndrome coronavirus-2 has been also associated with multiple direct and indirect cardiovascular complications including acute myocardial injury, myocarditis, arrhythmias, and venous thromboembolism. However, long term cardiovascular consequences from coronavirus disease 2019 are still unknown. The investigators sought to determine the pulmonary, cardiac and other physiologic limitations in patients who recovered from severe coronavirus disease 2019 with physiologic tests including PFTs, echocardiography and cardio-pulmonary exercise test which is currently the most comprehensive physiologic test that can differentiate between the different limitations and add novel data regarding short and long term physiologic consequences of coronavirus disease 2019.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
Cardiopulmonary Exercise Testing, COVID-19, Exertional dyspnea

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiopulmonary exercise test (CPET)
Arm Type
Experimental
Arm Description
Cardiopulmonary exercise testing (CPET) using a Quark CPET metabolic cart (Rome, Italy) according to American Thoracic Society (ATS) guidelines. A symptom-limited test on a treadmill will be performed, using incremental ramp Bruce protocol up to exhaustion. Patients who will not be able to perform the test on a treadmill will be tested on a cycle ergometer beginning with a no-resistance warm-up lasting 2-3 minutes, followed by incrementing resistance (8-30 Watts/minute) adapted to the patient's functional capacities according to the examiner's free judgment, up to exhaustion.
Intervention Type
Device
Intervention Name(s)
Cardiopulmonary exercise test (CPET)
Intervention Description
A symptom-limited test on a treadmill will be performed, using incremental ramp Bruce protocol up to exhaustion. Patients who will not be able to perform the test on a treadmill will be tested on a cycle ergometer beginning with a no-resistance warm-up lasting 2-3 minutes, followed by incrementing resistance (8-30 Watts/minute).
Primary Outcome Measure Information:
Title
Exercise capacity
Description
Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)
Time Frame
Measured continuously during 15 minutes of the exercise test (CPET)
Secondary Outcome Measure Information:
Title
Echocardiography
Description
Left ventricle shortening and ejection fraction, as well as possible cardiac structural or hemodynamic abnormalities will be evaluated by trans-thoracic echocardiography (iE33, Philips).
Time Frame
Ten minutes
Title
Six minute walk test
Description
The distance gained after six minute of habitual walking.
Time Frame
Six minutes of evaluation, completed pre cardiopulmonary exercise test.
Title
Spirometry
Description
Pulmonary function as assessed by spirometry.
Time Frame
Five minutes before and after the cardiopulmonary exercise testing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients recovering from COVID-19 with a documented infection with severe acute respiratory syndrome coronavirus-2 and cognitive ability to sign informed consent and physical ability to participate in exercise tests. Exclusion Criteria: Patients with severe pulmonary, cardiac disease prior to COVID-19, pregnant women, and patients with active infection or cancer.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ronen Bar-Yoseph, MD
Phone
+972-4-777-4360
Email
r_bar-yoseph@rambam.health.gov.il
First Name & Middle Initial & Last Name or Official Title & Degree
Yaniv Dotan, MD
Phone
+972-4-777-2650
Email
y_dotan@rambam.health.gov.il
Facility Information:
Facility Name
Rambam Medical Center
City
Haifa
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ronen Bar-Yoseph, MD
Phone
+972-4-777-4360
Email
r_bar-yoseph@rambam.health.gov.il
First Name & Middle Initial & Last Name & Degree
Yaniv Dotan, MD
Phone
+972-4-777-2650
Email
y_dotan@rambam.health.gov.il

12. IPD Sharing Statement

Learn more about this trial

Functional Capacity in Patients Post Mild COVID-19

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