Yogic Breathing and Guided Meditation for Long Covid Symptoms
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 189
- 试验地点
- 2
- 主要终点
- Compliance
研究概览
简要总结
This study aims to assess the impact of brief digitally delivered breathing practice and guided meditation on post-Covid physical and mental symptoms in Long Covid Patients.
详细描述
Long Covid symptoms can last weeks to months after the initial Covid infection or can appear weeks after. It can occur in those with mild disease or asymptomatic patients. Most commonly reported symptoms of Long Covid are:
- Tiredness or fatigue
- Difficulty thinking or concentrating (sometimes referred to as "brain fog")
- Headache
- Loss of smell or taste
- Dizziness on standing
- Fast-beating or pounding heart (also known as heart palpitations)
- Chest pain
- Difficulty breathing or shortness of breath
- Cough
- Joint or muscle pain
- Depression or anxiety
- Fever
- Symptoms that get worse after physical or mental activities
To this date, nearly 180 million people have been infected with Covid19 and over 3 million have lost their lives worldwide. The increasing prevalence of patients with Long Covid symptoms and the lack of effective solutions to address their condition, creates an urgent need for non-pharmacological interventions that are effective and scalable and can be delivered online to accommodate for the limitations due to the Covid pandemic.
Yogic Breathing and Meditation techniques have been shown to have various health benefits including improving pulmonary function and mental health. Prominent health institutions are recommending breathing exercise to their Covid patients to assist their respiratory recovery9. Meditation and breathing is also shown to help with Covid related stress and anxiety.
This study is a waitlisted randomized controlled trial conducted in 2 phases:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age between 18 and 70 years
- •Interested in attending the online Breathing and Wellness webinar.
- •Laboratory-confirmed (PCR) history of Covid-19 infection.
- •Long Covid condition diagnosis by a physician.
- •Able to read and comprehend English.
- •Currently residing in the United States.
排除标准
- •● Any medically limiting diagnosis that prevents a patient from doing the intervention or completing the assessments as determined by the PI such as severe Major Depression (under medication), Schizophrenia, Bipolar disorder.
结局指标
主要结局
Compliance
时间窗: For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.
The weekly compliance questionnaire is a tool which helps the participants to keep track of their activities each week. This enables the study team to measure compliance and protocol adherence by the participants by collecting information on their routine activity practiced and its frequency. This will be reported in "Number of days an intervention was practiced in a week". Compliance is defined as completing 60% (4 days/week or more) of the activity that is prescribed in the protocol. This means that at least one of the three practices (Isha Kriya, Nadi Shuddhi, or Simha Kriya) must be completed once a day for a minimum of four days.
次要结局
- Perceived Stress Scale (PSS)(For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.)
- Multidimensional Dyspnea Profile (MDP)(For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.)
- Profile of Mood States (POMS)(For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.)
- Quality of Life Survey (SF12)(For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.)
- Somatic Symptom Scale 8 Items (SS8)(For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.)
- Qualitative Assessments(For Phase 1 analysis: Baseline to 3 weeks. For Phase 2 analysis: Baseline to 6 weeks.)
研究者
Balachundhar Subramaniam
Professor of Anesthesia
Beth Israel Deaconess Medical Center