Evaluation of the Effectiveness of Breathing Control Technique on Long COVID Symptoms at the Reunion University Hospital Cardiac Coherence and Long COVID Symptoms (COCO-Long'Run)

C

Centre Hospitalier Universitaire de la Réunion

Status

Not yet enrolling

Conditions

Long COVID

Treatments

Other: Cardiac coherence

Study type

Interventional

Funder types

Other

Identifiers

NCT05851859
2022/CHU/35
2023-A00796-39 (Other Identifier)

Details and patient eligibility

About

Despite the controversy, on October 6, 2021, the World Health Organization (WHO) recognized Long Coronavirus disease (COVID) by officially defining it: " symptoms appeared 3 months after the onset of the primary infection by the Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2), persisting for at least 2 months and which cannot be explained by any other condition ". Long COVID can affects any type of patient and has polymorphic and fluctuating symptoms over time. The Reunion Island is a French overseas department located in the Indian Ocean accounting more than 860,000 inhabitants. It has recorded since March 11, 2020, nearly 491,825 cases of COVID-19 and 961 deaths of hospitalized patients. Reunion's population is multi-ethnic and younger than the metropolitan France's one. It also has a higher prevalence of obesity and type 2 diabetes, two serious form factors of COVID-19. This specific context makes this island a particular study site for Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and Long COVID. In addition, some studies have confirmed the involvement of the autonomic nervous system (ANS) in the symptomatology of Long COVID and demonstrated that patients with a Long COVID present a dysfunction of their ANS which is objectified by a reduced Heart Rate Variability (HRV). The regulation of heart rate by the ANS is strongly favored by respiration. A regular slow and deep breathing training helps to adjust the baroreflex, which connect heart rate, breathing and blood pressure. The result of this training is an induced state called "cardiac coherence" (CC). The investigator therefore hypothesize that respiratory training to CC could "re-educate" the ANS and durably improve the symptomatology of patients with Long COVID.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Patients over the age of 18,
  • living in Reunion and
  • having a diagnosis of Long COVID according to the World Health Organization (WHO) definition will be included in this study.
  • These patients must attest to their primary infection with Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) and present a negative antigen test at the time of inclusion.

Exclusion criteria

Patients:

  • with a chronic or disabling respiratory pathology preventing respiratory training (asthma, Chronic Obstructive Pulmonary Disease (COPD), active tuberculosis, pulmonary sequelae of COVID-19, etc.) practicing or having practiced a regular respiratory control technique (yoga, Cardiac coherence training, etc.) in the last 6 months
  • taking a beta-blocker, betamimetic, anti-arrhythmic, morphine, antidepressant treatment (Escitalopram)
  • having a pacemaker or severe heart disease
  • Current and known pregnancy or breastfeeding woman
  • with a cognitive deficit
  • under guardianship/curators or under judicial protection

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

200 participants in 2 patient groups

Complementary respiratory training to cardiac coherence (CC)
Experimental group
Description:
The " intervention " group will benefit from a complementary respiratory training to CC during 6 months in addition to the usual care procedure.
Treatment:
Other: Cardiac coherence
Usual care procedure in the event of Long COVID
No Intervention group
Description:
The " control " group will follow a usual care procedure in the event of Long COVID

Trial contacts and locations

0

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Central trial contact

Léa BRUNEAU

Data sourced from clinicaltrials.gov

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