Evaluation of the Effectiveness of Breathing Control Technique on Long COVID Symptoms at the Reunion University Hospital

NCT05851859 | Recruiting

• 2 other identifiers: 2022/CHU/352023-A00796-39
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Long COVID

Outcome Measures

Primary Outcomes (1)

• Evaluation of the effectiveness of a respiratory training to cardiac coherence on the reduction in the symptomatology of patients with Long COVID.

  mean score on the Long COVID Symptom Tool (ST) scale Score 0 to 53 / Higher score mean worse outcome

  6 months

Secondary Outcomes (7)

• Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of overall symptoms over time

  T0, 1 month, 2 months, 3 months, 6 months

• Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : fatigue

  3 months, 6 months

• Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : dyspnoea

  3 months, 6 months

• Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : Anxiety and Depression

  3 months, 6 months

• Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : cognitive disorders

  3 months, 6 months

Study Arms (2)

Complementary respiratory training to cardiac coherence (CC)

EXPERIMENTAL

The " intervention " group will benefit from a complementary respiratory training to CC during 6 months in addition to the usual care procedure.

Other: Cardiac coherence

Usual care procedure in the event of Long COVID

NO INTERVENTION

The " control " group will follow a usual care procedure in the event of Long COVID

Interventions

Cardiac coherence OTHER

Use of Cardiac coherence (complementary respiratory training) during 6 month

Complementary respiratory training to cardiac coherence (CC)

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de la Réunion: lead

Study Sites (2)

CHU de la Réunion

Saint-Denis, 97400, France

RECRUITING

CHU de la Réunion

Saint-Pierre, 97448, France

NOT YET RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Léa BRUNEAU

CONTACT

02 62 90 68 83; lea.bruneau@chu-reunion.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 4, 2023
• First Posted: May 10, 2023
• Study Start: May 5, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: July 30, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)