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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05217875
Other study ID # 2021-01698
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2021
Est. completion date August 2022

Study information

Verified date December 2021
Source Hôpital du Valais
Contact Pierre-Olivier v Bridevaux
Phone +41792079069
Email pierre-olivier.bridevaux@hopitalvs.ch
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date August 2022
Est. primary completion date June 2022
Accepts healthy volunteers No
Gender All
Age group 14 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland Centre hospitalier du valais romand Martigny

Sponsors (1)

Lead Sponsor Collaborator
Hôpital du Valais

Country where clinical trial is conducted

Switzerland, 

Outcome

Type Measure Description Time frame Safety issue
Primary Persistence/resolution of dysfunctional breathing at follow-up visit 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 Change in ventilatory patterns (tidal volume [VT], breathing frequency [BF] at isowork as compared with baseline 6 to 9 monts from diagnosis
Secondary Dispersion of VT and BF during the CPET 6 to 9 monts from diagnosis
Secondary Change in ETCO2 and PaCO2 6 to 9 monts from diagnosis
Secondary Qualitative changes (increase/decrease/no change of DB pattern of CPET) 6 to 9 monts from diagnosis
Secondary Score HADS changes 6 to 9 monts from diagnosis
Secondary Score SF-36 changes 6 to 9 monts from diagnosis
Secondary Specific symptom scale changes 6 to 9 monts from diagnosis
Secondary Specific work capacity changes questions 6 to 9 monts from diagnosis
Secondary Post-COVID Functional Status (PCFS) changes 6 to 9 monts from diagnosis
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