The Effect of a Digital MediYoga Program on Quality of Life, Blood Pressure and Heart Rate Among Patients With Atrial Fibrillation

Condition(s) studied

Investigational drug(s) / intervention(s)

Yoga 20 minutes: The 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: The 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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Arrythmia-Specific Symptoms and Health-Related Quality — Baseline, and at 3 and 6 months after enrollment
  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

Trial sites (1)

More Herlev and Gentofte Hospital trials in Denmark

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