Effects of yoga compared with health promotion on health-related quality of life in adults with post-COVID-19 condition: protocol for a randomised controlled trial

Abstract

Introduction: 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.

Methods and analysis: 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.

Ethics and dissemination: 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.

Trial registration number: German Clinical Trials Register, DRKS00032837.

Keywords: Fatigue; MENTAL HEALTH; PUBLIC HEALTH; Post-Acute COVID-19 Syndrome; Quality of Life; Randomized Controlled Trial.

Figure 1. Participant flowchart for parallel design based on the CONSORT guidelines for transparent reporting of trials. CONSORT, Consolidated Standards of Reporting Trials; GP, general practitioner; PSQI, Pittsburgh sleep quality index; SF-36, 36-item Short Form.

Figure 2. Schedule of enrolment, interventions and assessments, according to SPIRIT guidelines. BMI, body mass index; BP, blood pressure; FSS, Fatigue Severity Scale; HADS, Hospital Anxiety and Depression Scale; HR-QoL, health-related quality of life; HRV, heart rate variability; IPAQ-SF, International Physical Activity Questionnaire Short Form; MDP, Multidimensional Dyspnea Profile; MFS, Mental Fatigue Scale; PSQI, Pittsburgh Sleep Quality Index; RHR, resting heart rate; SF-36, 36-item Short Form Health Survey; SPIRIT, Standard Protocol Items: Recommendations for Interventional Trials; TMT A+B, Trail Making test A+B; VF, Verbal Fluency; WHR, waist–hip ratio.