Abstract
INTRODUCTION: Post-COVID-19 syndrome, defined by persistent symptoms lasting beyond 12 weeks of a SARS-CoV-2 infection, affects both severe and mild COVID-19 cases. Fatigue is the most common symptom, impacting 58% of patients. Other symptoms include mental symptoms, cardiovascular and respiratory issues and autonomic dysfunction. Chronic inflammation and immune dysregulation seem to be associated with post-COVID-19 fatigue. Despite its impact on healthcare and the economy, effective treatments are limited. Yoga and health education have been shown to be effective for fatigue in other related conditions. The aim of this study, therefore, is to investigate the efficacy, safety and cost-effectiveness of yoga and health education on post-COVID-19 persistent fatigue. METHODS AND ANALYSIS: A randomised controlled trial with 100 patients with persistent fatigue due to post-COVID-19 syndrome is being conducted at three study centres. Patients are randomised to two interventions, yoga and health education. Both interventions include 12 weeks of 90 min supervised group sessions and 60 min of home practice per week. The primary outcome measure is fatigue on the Chalder Fatigue Scale 12 weeks after randomisation. Secondary outcome measures include postexertional malaise (DePaul Symptom Questionnaire), health-related quality of life (Short Form Health Survey-12 Item Version, EuroQol 5-Dimension 5-Level Questionnaire), anxiety, depression (Hospital Anxiety and Depression Scale), stress (Perceived Stress Scale), sleep quality (Pittsburgh Sleep Quality Index), hand grip strength, laboratory parameters and adverse events. Physical activity analysis over 7 days using a body-worn sensor and 24-hour heart rate variability using a 3-channel ECG recorder are assessed exploratively. All outcome measures will be assessed 12 and 24 weeks after randomisation. In addition, health economic analyses as well as mediator and moderator analyses including self-reported body awareness, self-efficacy, personality traits and treatment credibility/expectations will be conducted. Furthermore, qualitative interviews at week 12 will be carried out. ETHICS AND DISSEMINATION: The trial received ethical approval from the Ethics Committee of the University Hospital Tübingen (approval number: 775/2022BO2). Results will be disseminated via peer-reviewed open-access publications, scientific conferences and targeted communication to patient organisations, healthcare providers and the wider public. TRIAL REGISTRATION NUMBER: NCT05890599.