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A study of yoga for the management of atrial fibrillatio

Not Applicable
Conditions
atrial fibrillation
Cardiovascular - Other cardiovascular diseases
Physical Medicine / Rehabilitation - Other physical medicine / rehabilitation
Registration Number
ACTRN12624000264583
Lead Sponsor
Alfred Health
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot yet recruiting
Sex
All
Target Recruitment
244
Inclusion Criteria

Disease status: Persons with paroxysmal or persistent AF undertaking a rhythm control strategy who have not undergone an AF ablation in the past 6 months

Willingness and ability to given written informed consent and comply with the study protocol

Physical ability to undertake Yoga and willing to commit to regular practice for 12 months

Medicare eligible Australian residents

Internet access

Exclusion Criteria

Regular yoga practice in last 6 months

Permanent AF

AF ablation in the past 6 months, or likely to undergo AF ablation in the next 6 months

The absence of AF lasting >30 seconds in the past 3 months documented by 12-lead electrocardiogram (ECG), ambulatory monitoring or device interrogation

Contraindications to yoga such as an inability to participate due to musculoskeletal condition

Severe valvular dysfunction

Acute myocardial infarction (AMI) or cardiac surgery in preceding 6 months

Uncontrolled thyroid disease, autoimmune or systemic inflammatory disease

Dementia, cognitive impairment or lack of English language ability to a degree that would impair ability to understand instructions and participate in yoga class

Advanced malignancy or other medical condition resulting in life expectancy < 12 months

People not eligible for Medicare

Unwilling to have an implantable cardiac monitor (ICM) inserted and inability/unwillingness to use Alivecor device or smart watch.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Time to atrial fibrillation (AF) recurrence, defined as any atrial tachyarrhythmia lasting > 1 hour (after a 4-week blanking period) as a time to event analysis.<br><br><br><br>[AF episodes as detected by implantable cardiac monitor, twice daily alivecor transmissions, or smart watch. Baseline and 12 months post baseline.];AF burden at 12 months (excluding an initial 4-week blanking period)[AF burden as determined by implantable cardiac monitor, twice daily alivecor transmissions, or smart watch. Baseline and 12 months post baseline.]
Secondary Outcome Measures
NameTimeMethod
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