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

Официальное название

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

Обзор

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.

Вмешательства

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

Первичные конечные точки

• Evaluation of the effectiveness of a respiratory training to cardiac coherence on the reduction in the symptomatology of patients with Long COVID. [Срок оценки: 6 months]

Вторичные конечные точки (7)

• Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of overall symptoms over time [Срок оценки: 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 [Срок оценки: 3 months, 6 months]
• Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : dyspnoea [Срок оценки: 3 months, 6 months]
• Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : Anxiety and Depression [Срок оценки: 3 months, 6 months]
• Evaluation of the effectiveness of a respiratory training to cardiac coherence on the decrease of specifics symptoms : cognitive disorders [Срок оценки: 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 [Срок оценки: 3 months, 6 months]
• Evaluation of the effectiveness of a respiratory training to CC on the impact of the disease on daily life [Срок оценки: T0, 1 month, 2 months, 3 months, 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Франция · 2 центра

• CHU de la Réunion — Saint-Denis
• CHU de la Réunion — Saint-Pierre

Идентификаторы

NCT: NCT05851859 · 2022/CHU/35 · 2023-A00796-39

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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