Randomized Controlled Trial Evaluating the Effectiveness of a Breathing Control Technique on Long COVID Symptoms at the Reunion University Hospital
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 200
- 试验地点
- 3
- 主要终点
- Evaluation of the effectiveness of a respiratory training to cardiac coherence on the reduction in the symptomatology of patients with Long COVID.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Cardiac coherence (Other)
Usual care procedure in the event of Long COVID
The " control " group will follow a usual care procedure in the event of Long COVID
结局指标
主要结局
Evaluation of the effectiveness of a respiratory training to cardiac coherence on the reduction in the symptomatology of patients with Long COVID.
时间窗: 6 months
mean score on the Long COVID Symptom Tool (ST) scale Score 0 to 53 / Higher score mean worse outcome
次要结局
- 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 CC on the impact of the disease on daily life(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 : cognitive disorders(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 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 : Anxiety and Depression(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(3 months, 6 months)