Investigation of mechanisms involved in exercise intolerance in patients with long-Covid

Pathophysiology of exercise intolerance in Long Covid: an integrated investigation of cardiorespiratory, muscular, metabolic and neurological mechanisms

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-7kyk2wy

Enrollment

Unknown

Registered

2024-02-15

Start date

2023-11-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post-Acute COVID-19 Syndrome

Interventions

This is a two-arm, double-blind, randomized controlled clinical trial. During the study, each recruited participant will undergo 4 initial visits. At visit 1 we will carry out a clinical assessment in

D27.505.519.389.275

Eligibility

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Adult individuals; minimum age 18 years; of both sexes; with persistent symptoms after 3 months of Covid19 infection and with right ventricular preload dysfunction (defined by a right atrial pressure at peak exercise <7 mmHg assessed during an Invasive Cardiopulmonary Exercise Testing - iCPET)

Exclusion criteria

Exclusion criteria: Patients who are unable to perform cycling exercise in order to perform an Invasive Cardiopulmonary Exercise Testing (iCPET) correctly, either due to neuromuscular limitation or due to musculoskeletal limitation

Design outcomes

Primary

Measure	Time frame
Change in absolute values in right atrial pressure (mmHg) between resting state and peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.	—

Secondary

Measure	Time frame
Change in absolute values in right atrial pressure (mmHg) at peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in peak exercise oxygen consumption (% predicted) assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in oxygen consumption (% predicted) between resting state and peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in cardiac output (L/min) at peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in cardiac output (L/min) between resting state and peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in pulmonary artery occlusion pressure (mmHg) at peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in pulmonary artery occlusion pressure (mmHg) between resting state and peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in indexed systolic volume (mL/beat/m2) at peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in indexed systolic volume (mL/beat/m2) change between resting state and peak exercise as assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in peripheral oxygen extraction (mL of oxigen/g) rate at peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in ventilatory efficiency (VE/VCO2 slope) )during physical exer	—

Measure

Time frame

Change in absolute values in right atrial pressure (mmHg) at peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in peak exercise oxygen consumption (% predicted) assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in oxygen consumption (% predicted) between resting state and peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in cardiac output (L/min) at peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in cardiac output (L/min) between resting state and peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in pulmonary artery occlusion pressure (mmHg) at peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in pulmonary artery occlusion pressure (mmHg) between resting state and peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in indexed systolic volume (mL/beat/m2) at peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in indexed systolic volume (mL/beat/m2) change between resting state and peak exercise as assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in peripheral oxygen extraction (mL of oxigen/g) rate at peak exercise assessed by the Invasive Cardiopulmonary Exercise Test performed before and after the intervention.;Change in absolute values in ventilatory efficiency (VE/VCO2 slope) )during physical exer

—

Countries

Brazil

Contacts

Public ContactAna Carolina Duarte

Universidade Federal de São Paulo

acb.duarte@unifesp.br+55 11 93345-2427

Outcome results

None listed

Source: REBEC (via WHO ICTRP)