Functional Capacity in Patients Post Mild COVID-19

NCT05323760 | Unknown

• 1 other identifier: 0760-20-RMB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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").

Conditions

COVID-19

Keywords

Cardiopulmonary Exercise Testing; COVID-19; Exertional dyspnea

Outcome Measures

Primary Outcomes (1)

• Exercise capacity

  Oxygen uptake evaluated by cardiopulmonary exercise testing (CPET)

  Measured continuously during 15 minutes of the exercise test (CPET)

Secondary Outcomes (3)

• Echocardiography

  Ten minutes

• Six minute walk test

  Six minutes of evaluation, completed pre cardiopulmonary exercise test.

• Spirometry

  Five minutes before and after the cardiopulmonary exercise testing

Study Arms (1)

Cardiopulmonary exercise test (CPET)

EXPERIMENTAL

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.

Device: Cardiopulmonary exercise test (CPET)

Interventions

Cardiopulmonary exercise test (CPET) DEVICE

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).

Cardiopulmonary exercise test (CPET)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Rambam Health Care Campus: lead

Study Sites (1)

Rambam Medical Center

Haifa, Israel

RECRUITING

MeSH Terms

Conditions

COVID-19

Interventions

Exercise Test

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Central Study Contacts

Ronen Bar-Yoseph, MD

CONTACT

+972-4-777-4360; r_bar-yoseph@rambam.health.gov.il

Yaniv Dotan, MD

CONTACT

+972-4-777-2650; y_dotan@rambam.health.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2022
• First Posted: April 12, 2022
• Study Start: September 9, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2023
• Last Updated: April 12, 2022

Record last verified: 2022-04

Locations

IL (1)