Department of Global Public Health, Karolinska Institutet, Stockholm, Sweden.
Indian Institute of Public Health, Public Health Foundation of India, Gandhinagar, Gujarat, India.
BMJ Open. 2024 Sep 12;14(9):e085525. doi: 10.1136/bmjopen-2024-085525.
Post-COVID-19 condition (post COVID, also known as long COVID) is a global public health issue estimated to affect over 100 million people. Common symptoms include fatigue, dyspnoea and cognitive dysfunction ('brain fog'). Over time, these symptoms have an adverse effect on mental health, physical activity and quality of life (QoL). The condition requires innovative and feasible treatment approaches that can be effective and self-managed. Physical activity is essential for good health; however, aerobic exercise or weightlifting may not be suitable for post COVID patients who experience fatigue or breathlessness. The benefits of yoga include improved flexibility, mobility, body strength and balance. It is also shown to reduce symptoms of fatigue and improve breathing efficiency, mental health and QoL. This study protocol describes the rationale and methods for a randomised controlled trial (RCT) of a yoga-based intervention designed for adults with post COVID.
A two-group, parallel, RCT with blinded follow-up assessments. Participants will be randomised with a 1:1 allocation to either a 12-week yoga-based intervention or a 12-week health promotion (active comparison) intervention. In total, 88 participants aged 30-65 years will be recruited and randomised. The primary outcome is health-related QoL (36-item Short-Form). Secondary outcomes are dyspnoea, fatigue, sleep quality, cognitive functions, mental fatigue, depression, anxiety, physical activity, demographic data and physical health measures. Data will be analysed as intention-to-treat basis, using linear mixed modelling. All assessments are conducted at Karolinska Institutet in Stockholm, Sweden. The yoga-based intervention will take place at a yoga studio centrally located in Stockholm city.
The study is approved by the Swedish Ethical Review Authority, reference number 2023/06518-01. All participants must sign written informed consent before enrolment and are free to withdraw from the study at any point. Key results will be available through research articles and seminars.
German Clinical Trials Register, DRKS00032837.
新冠后状况（后新冠，也称为长新冠）是一个全球性的公共卫生问题，据估计影响了超过 1 亿人。常见症状包括疲劳、呼吸困难和认知功能障碍（“脑雾”）。随着时间的推移，这些症状对心理健康、身体活动和生活质量（QoL）产生了不利影响。该病症需要创新且可行的治疗方法，这些方法必须是有效且可自我管理的。身体活动对健康至关重要；然而，对于经历疲劳或呼吸困难的新冠后患者，有氧运动或举重可能并不合适。瑜伽的好处包括提高柔韧性、移动性、身体力量和平衡。它还被证明可以减轻疲劳症状，提高呼吸效率、心理健康和生活质量。本研究方案描述了一项针对新冠后成年人的基于瑜伽的干预措施的随机对照试验（RCT）的原理和方法。
这是一项具有盲法随访评估的 2 组平行 RCT。参与者将以 1:1 的比例随机分配到 12 周的基于瑜伽的干预组或 12 周的健康促进（主动对照）干预组。总共将招募和随机分配 88 名年龄在 30-65 岁之间的参与者。主要结局是与健康相关的生活质量（36 项简短式健康调查）。次要结局是呼吸困难、疲劳、睡眠质量、认知功能、精神疲劳、抑郁、焦虑、身体活动、人口统计学数据和身体健康测量。数据将根据意向治疗原则进行分析，使用线性混合模型。所有评估都在瑞典斯德哥尔摩的卡罗林斯卡学院进行。基于瑜伽的干预将在斯德哥尔摩市中心的一个瑜伽工作室进行。
该研究已获得瑞典伦理审查局的批准，注册号为 2023/06518-01。所有参与者在注册前必须签署书面知情同意书，并且可以随时退出研究。主要结果将通过研究文章和研讨会公布。
德国临床试验注册处，DRKS00032837。
