The Effect of a Digital MediYoga Program on Quality of Life, Blood Pressure and Heart Rate Among Patients With Atrial Fibrillation
The Effect of MediYoga on Quality of Life, Blood Pressure and Heart Rate Among Patients With Atrial Fibrillation: A Randomized Controlled Trial
1 other identifier
interventional
456
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Sep 2025
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2025
CompletedFirst Submitted
Initial submission to the registry
September 26, 2025
CompletedFirst Posted
Study publicly available on registry
January 7, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2028
January 7, 2026
January 1, 2026
1.8 years
September 26, 2025
January 5, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
Baseline, and at 3 and 6 months after enrollment
Secondary Outcomes (4)
Health-Related Quality of Life
Baseline, and at 3 and 6 months after enrollment
Mental health
Baseline, and at 3 and 6 months after enrollment
Blood pressure
Baseline, and at 3 and 6 months after enrollment
Pulse
At baseline, and 3 and 6 months after enrollment
Study Arms (3)
Intervention Group I, yoga 20 minutes x3 pr week
EXPERIMENTALIntervention group II, yoga 60 minutes x1 pr week
EXPERIMENTALControl group
NO INTERVENTIONTreatment as usual
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Elevated TSH Hormone
- Participated in mindfulness or yoga exercise regularly at any point during the last two years.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Herlev and Gentofte Hospitallead
- Sophiahemmetcollaborator
Study Sites (1)
Herlev and Gentofte University Hospital
Herlev, 2730, Denmark
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor, PhD, RN, Senior Researcher
Study Record Dates
First Submitted
September 26, 2025
First Posted
January 7, 2026
Study Start
September 1, 2025
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
September 1, 2028
Last Updated
January 7, 2026
Record last verified: 2026-01
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, ICF
Data will be shared upon reasonable request