Digital MediYoga for quality of life and heart measures in paroxysmal atrial fibrillation
The Effect of MediYoga on Quality of Life, Blood Pressure and Heart Rate Among Patients With Atrial Fibrillation: A Randomized Controlled Trial
This trial will test whether a 12-week, app-delivered MediYoga program can improve disease-specific quality of life and reduce blood pressure and heart rate in adults with paroxysmal atrial fibrillation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 456 (estimated) |
| Sex | All |
| Sponsor | Herlev and Gentofte Hospital Academic / other |
| Locations | 1 site (Herlev) |
| Trial ID | NCT07321964 on ClinicalTrials.gov |
What this trial studies
This randomized controlled trial enrolls 456 adults with paroxysmal atrial fibrillation and an EHRA score of 2 or higher to compare a 12-week digital MediYoga program (delivered via smartphone app with online Teams support) versus usual care. The intervention includes guided low-intensity yoga, deep breathing, and meditation sessions of differing lengths (20 or 60 minutes). Data are collected at baseline, 3, 6, and 12 months, with the primary outcome being disease-specific quality of life and secondary outcomes including blood pressure, heart rate, generic quality of life, and psychological wellbeing. Qualitative interviews will also explore participants' experiences and acceptability of the digital program.
Who should consider this trial
Good fit: Adults (18+) with a diagnosis of paroxysmal atrial fibrillation, EHRA score ≥2, who own a smartphone or tablet, read and speak Danish, and have no comorbidity that prevents participation are ideal candidates.
Not a fit: Patients with significant comorbidities that restrict physical activity, elevated TSH, those who regularly practiced mindfulness or yoga in the past two years, or those who cannot read/speak Danish are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the program could improve symptoms and disease-specific quality of life and also help lower blood pressure and resting heart rate in people with paroxysmal AF.
How similar studies have performed: Smaller and pilot studies of yoga and breathing-based interventions for AF and cardiovascular outcomes have shown promising effects on symptoms, stress, and blood pressure, but large fully digital randomized trials are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 18 and above * Diagnosed with paroxysmal atrial fibrillation * EHRA score at 2 or more * Owner of a smartphone or tablet * Speaking and reading Danish * No comorbidity that restricts them from participating in the intervention Exclusion Criteria: * Elevated TSH Hormone * Participated in mindfulness or yoga exercise regularly at any point during the last two years.
Where this trial is running
Herlev
- Herlev and Gentofte University Hospital — Herlev, Denmark (Recruiting)
Study contacts
- Study coordinator: Signe S Risom, Associated Professor
- Email: signe.stelling.risom@regionh.dk
- Phone: +45 5163 2786
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.