Atrial fibrillation (AF) is the most common cardiac arrythmia, associated with increased risk of stroke, heart failure, reduced quality of life (QoL), and psychological distress. This randomized controlled trial investigates the effect of MediYoga - a program incorporating deep breathing, low-intensity yoga, and meditation- on disease-specific QoL, blood pressure, and heart rate in 456 patients with paroxysmal AF. With a strong focus on sustainability, the study is fully digital: participants are recruited online, and the 12-week intervention is delivered through an application to smartphone. Additionally, the participants receive online support via Teams. Data will be collected at baseline, 3, 6, and 12 months. The primary outcome is disease specific QoL; secondary outcomes include blood pressure, heart rate, generic QoL, and psychological wellbeing.
Qualitative interviews will explore patients' experiences with the intervention.
Aged 18 and above
Diagnosed with paroxysmal atrial fibrillation
EHRA score at 2 or more
Owner of a smartphone or tablet
Elevated TSH Hormone
Participated in mindfulness or yoga exercise regularly at any point during the last two years.
Parallel
Yoga 20 minutes
BehavioralThe intervention consists of 60 minutes of weekly MediYoga over a 12-week period. Participants in the intervention group may choose whether they prefer to practice yoga for 20 minutes three times per week, or for 60 minutes once per week. The yoga sessions are delivered via a smartphone application, guiding participants through the sessions with both video and audio. In addition, participants are required to complete three questionnaires and measure blood pressure and heart rate at baseline, and at 3 and 6 months of follow-up.
Yoga 60 minutes
BehavioralThe intervention consists of 60 minutes of weekly MediYoga over a 12-week period. Participants in the intervention group may choose whether they prefer to practice yoga for 20 minutes three times per week, or for 60 minutes once per week. The yoga sessions are delivered via a smartphone application, guiding participants through the sessions with both video and audio. In addition, participants are required to complete three questionnaires and measure blood pressure and heart rate at baseline, and at 3 and 6 months of follow-up.
Arrythmia-Specific Symptoms and Health-Related Quality
The validated form is divided into three parts: (1) evaluation of the most recent episode of arrythmia and current medication (2) assessment of symptom burden, including a 9-point symptom scale (ASTA symptom scale) with a 4-point response scale, and (3) assessment of the HRQoL using a 13-point scale (ASTA scale) with the same 4-point response scale as the symptom scale. The ASTA scale is further divided into a physical and a mental subscale. Scores range from 0 to 100, with higher scores reflecting a higher symptom burden and a worse impact on HRQoL due to arrythmia
Health-Related Quality of Life
The SF-36 is a standardized, validated, and reliable general HRQoL questionnaire containing 36 items. The questionnaire is commonly used in AF studies. The items are divided into eight domains and two component summary scales reflecting physical and mental health re-spectively. The two summary scales are analysed on a 0-100 scale, where 100 represents the best possible HRQoL.
Mental health
HADS is a reliable and validated instrument for screening for clinically relevant symptoms of anxiety and depression in patients. The scale consists of 14 items assessing how patients felt during the previous week. Patients must answer every question in a 4-point Likert scale from 0 to 3. Seven of the items assess the level of depression, and the remaining seven the level of anxiety. Scores are summarized separately for anxiety and depression, resulting in two scores with a range of 0-21. Higher scores indicate more symptoms of anxiety and depression
Blood pressure
Blood pressure
Pulse
Pulse monitoring
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Herlev and Gentofte Hospital
Lead sponsor
Sophiahemmet
Collaborator
