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

Long COVID Clinical Trial

— COCO-Long'Run  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05851859
• Other study ID #: 2022/CHU/35
• Secondary ID: 2023-A00796-39
• Status: Not yet recruiting
• Phase: N/A
• Start date: March 29, 2024
• Est. completion date: November 1, 2026

Study information

• Verified date: February 2024
• Source: Centre Hospitalier Universitaire de la Réunion
• Contact: Léa BRUNEAU
• Phone: 02 62 90 68 83
• Email: lea.bruneau[@]chu-reunion.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: November 1, 2026
• Est. primary completion date: September 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Long COVID

Intervention

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

Locations

Country	Name	City	State
France	CHU de la Réunion	Saint-Denis
France	CHU de la Réunion	Saint-Pierre

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de la Réunion

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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