Prognostic of Dysfunctional Breathing in Long Covid: a Follow up Study

January 31, 2022 updated by: Hôpital du Valais
Dysfunctional breathing might participate to dyspnoea in long COVID-19. This study investigate the prognosis of patients diagnosed with dysfunctional breathing after SARS-CoV-2 infection in our center.

Study Overview

Status

Recruiting

Conditions

Detailed Description

Dysfunctional breathing (DB) with or without hyperventilation syndrome (HVS) as diagnosed using cardiopulmonary exercise test (CPET) was recently demonstrated as an important physiopathological mechanism of persistent dyspnoea in long COVID patients [1]. DB is characterized by specific ventilation pattern on CPET accompanied by respiratory discomfort and/or dyspnea at exercise [2]. Most patients with DB will have undergone some sort a specific physiotherapy retraining [3]. However the prognostic and the predictors of persistence/resolution of DB after severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection are unknown.

The aim of the study is to determine the prognostic of patients diagnosed with DB after SARS-CoV-2 infection, as well as prognosis factors and predictors of persistence/resolution of DB during a prospective follow up visit.

Study Type

Observational

Enrollment (Anticipated)

50

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

Study Locations

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

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

- Patients of 14 years or more diagnosed with DB after COVID-19 using a combined approach of symptoms and CPET in the Hospitals of Sion, of Martigny or Rennaz

Description

Inclusion Criteria:

  • patients 14 years or more
  • diagnosis of DB after SARS-CoV-2 at our long covid clinic using a combined approach of symptoms and CPET analysis in the hospitals of Sion, Martigny or Rennaz
  • Inclusion between November 2020 and until the end of October 2021

Exclusion Criteria:

  • Refusal to participate
  • comorbidities preventing the CPET or PFT to be carried out

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Persistence/resolution of dysfunctional breathing at follow-up visit
Time Frame: 6 to 9 monts from diagnosis
defined by persistence/resolution of dyspnea, as compared with patient's baseline (equivalent level of dyspnea as before COVID-19).
6 to 9 monts from diagnosis

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in ventilatory patterns (tidal volume [VT], breathing frequency [BF] at isowork as compared with baseline
Time Frame: 6 to 9 monts from diagnosis
6 to 9 monts from diagnosis
Dispersion of VT and BF during the CPET
Time Frame: 6 to 9 monts from diagnosis
6 to 9 monts from diagnosis
Change in ETCO2 and PaCO2
Time Frame: 6 to 9 monts from diagnosis
6 to 9 monts from diagnosis
Qualitative changes (increase/decrease/no change of DB pattern of CPET)
Time Frame: 6 to 9 monts from diagnosis
6 to 9 monts from diagnosis
Score HADS changes
Time Frame: 6 to 9 monts from diagnosis
6 to 9 monts from diagnosis
Score SF-36 changes
Time Frame: 6 to 9 monts from diagnosis
6 to 9 monts from diagnosis
Specific symptom scale changes
Time Frame: 6 to 9 monts from diagnosis
6 to 9 monts from diagnosis
Specific work capacity changes questions
Time Frame: 6 to 9 monts from diagnosis
6 to 9 monts from diagnosis
Post-COVID Functional Status (PCFS) changes
Time Frame: 6 to 9 monts from diagnosis
6 to 9 monts from diagnosis

Collaborators and Investigators

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

Sponsor

Hôpital du Valais

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 (Actual)

November 1, 2021

Primary Completion (Anticipated)

June 1, 2022

Study Completion (Anticipated)

August 1, 2022

Study Registration Dates

First Submitted

January 31, 2022

First Submitted That Met QC Criteria

January 31, 2022

First Posted (Actual)

February 1, 2022

Study Record Updates

Last Update Posted (Actual)

February 1, 2022

Last Update Submitted That Met QC Criteria

January 31, 2022

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-01698

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data upon reasonable requests

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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