We thank Dr Shridevi and colleagues for their feedback on the yoga AF trial and seek to address the important points raised.
Untangling the impact of yoga from the benefits of a structured exercise program, is an important consideration, given the known benefits of physical activity in an AF population. In 60 hypertensive participants randomized to either 15 minutes of yoga or stretching, in addition to 30 minutes of aerobic exercise, the yoga group experienced greater reductions in blood pressure and heart rate, despite all patients undertaking a structured, supervised program. In the Yoga-AF trial, all participants will keep detailed exercise diaries recording activity type, duration and intensity to calculate METs. Additionally, all participants undergo cardiopulmonary exercising testing at baseline and 12 months, so that the impact of changes in cardiopulmonary fitness between groups can be determined.
We agree that continuous monitoring with implantable loop recorders (ILR) for all participants would be preferable, and this is strongly encouraged. To assist enrolment and avoid excluding patients unwilling to accept an ILR the option of a smart watch has been included in the study protocol. Randomization has been stratified by monitoring type (implanted cardiac device vs smartwatch) to ensure balance between the control and yoga groups. While weekly trans telephonic monitoring has been shown to miss a proportion of AF episodes compared with continuous monitoring, a much higher frequency of ECG transmissions is required in the Yoga-AF study (twice daily, plus at time of symptoms and device detected AF burden if available). This approach was successfully applied in the Alcohol-AF trial. AF burden will be calculated using the time in AF derived from all patient recorded ECGs, which are adjudicated by independent cardiologists, removing any bias from device related differences in AF sensitivity.
Lack of blinding is an issue inherent to all lifestyle intervention trials. To combat this study investigators, do not have any role in AF management for participants, and do not routinely inform patients and treating clinicians of ILR detected AF episodes. A record of all interventions for AF (medication changes, cardioversion, ablation) during the study period is recorded, hence any differences in the intensity of AF management between groups can be adjusted for. Adjudication of the primary endpoint is performed by cardiologists blinded to group allocation.
Conflict of interest
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