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

Randomized Controlled Trial Evaluating the Effectiveness of a Breathing Control Technique on Long COVID Symptoms at the Reunion University Hospital

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.

Study Overview

• Status: Recruiting
• Conditions: Long COVID
• Intervention / Treatment: Other: Cardiac coherence

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Léa BRUNEAU; Phone Number: +262 02 62 90 68 83; Email: lea.bruneau@chu-reunion.fr

Study Locations

• France
  • Saint-Denis, France, 97400
    • Recruiting
    • CHU de la réunion
    • Principal Investigator: Erick GOKALSING, MD
    • Contact: Léa BRUNEAU, MD; Phone Number: +262262906883; Email: lea.bruneau@chu-reunion.fr
    • Principal Investigator: Léa BRUNEAU, MD
    • Principal Investigator: Patrick GERARDIN, MD
  • Saint-Pierre, France, 97448
    • Not yet recruiting
    • CHU de la réunion
    • Contact: Lucie AUZANNEAU; Phone Number: +262 02 62 35 99 49; Email: lucie.auzanneau@chu-reunion.fr
    • Principal Investigator: Patrick GERARDIN

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complementary respiratory training to cardiac coherence (CC); 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; Use of Cardiac coherence (complementary respiratory training) during 6 month
No Intervention: Usual care procedure in the event of Long COVID; The " control " group will follow a usual care procedure in the event of Long COVID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of overall symptoms over time	Long COVID Symptom Tool (ST) scale Score 0 to 53 / Higher score mean worse outcome	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	The 11-item Chalder Fatigue Scale (CFS-11) score 0 to 11 / Higher score mean worse outcome	3 months, 6 months
Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : dyspnoea	Modified Medical Research Council (MMRC) dyspnoea scale score 0 to 5 / Higher score mean worse outcome	3 months, 6 months
Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : Anxiety and Depression	Hospital Anxiety and Depression scale (HADS) Score 0 to 42 / Higher score mean worse outcome	3 months, 6 months
Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : cognitive disorders	Montreal Cognitive Assessment (MoCA) Score 0 to 30 / Higher score mean better outcome	3 months, 6 months
Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : Post Traumatic Stress Disorder	Posttraumatic Stress Disorder Checklist for Diagnostic and statistical manual of mental disorders, version 5 (PCL-5) Score 0 to 80 / Higher score mean worse outcome	3 months, 6 months
Evaluation of the effectiveness of a respiratory training to CC on the impact of the disease on daily life	Long COVID Impact Tool (IT) scale Score 0 to 60 / Higher score mean worse outcome	T0, 1 month, 2 months, 3 months, 6 months

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de la Réunion

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2025
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): April 1, 2027

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 9, 2023
• First Posted (Actual): May 10, 2023

Study Record Updates

• Last Update Posted (Actual): July 30, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 2022/CHU/35; 2023-A00796-39 (Other Identifier: idRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No