Category
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Primary study
Registry of Trials»ANZCTR
Year
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2024
INTERVENTION: The intervention will consistent of 60min yoga classes three times a week for 12 months. Participants will attended group yoga classes in person at a local yoga studio for the first three months to ensure participants learn proper technique, after this, they will have the option to transition to an online format if preferred. The first 4‐weeks after commencing yoga will be the blanking period in which AF episodes will not count towards the primary endpoint. From a participant perspective the 4 week blanking period will not involve anything different. All classes will be delivered by a qualified yoga instructor. Yoga classes will involve participants performing a series of physical postures with coordinated controlled breathing. Classes will be taught in the Hatha, Vinyasa, Iyengar or Yin yoga style. Participants will keep an activity diary to log their yoga participation. Study investigators will also review attendance records from the yoga studios/ online classes where available. A subgroup of 10 patients in each arm will undergo microneurography to measure MNSA. These participants will be randomly selected. MNSA will be measured at baseline and 12 months post baseline. Measurement of MNSA will take 2‐3 hours and involve insertion of a microelectrode into the peroneal nerve. CONDITION: atrial fibrillation; ; atrial fibrillation Cardiovascular ‐ Other cardiovascular diseases Physical Medicine / Rehabilitation ‐ Other physical medicine / rehabilitation PRIMARY OUTCOME: 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.] 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.; ; ; ; [AF episodes as detected by implantable cardiac monitor, twice daily alivecor transmissions, or smart watch. Baseline and 12 months post baseline.] 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 SECONDARY OUTCOME: Anxiety [hospital anxiety and depression score (HADS) Baseline and 12 months post baseline. ] Cardio‐pulmonary fitness[cardiopulmonary exercise testing Baseline and 12 months post baseline.] Change in lipid profile ‐ triglycerides[measurement of triglycerides on a fasting blood test baseline and 12 months post baseline] Change in lipid profile ‐HDL[measurement of HDL cholesterol on a fasting blood test baseline and 12 months post baseline] Change in lipid profile‐ LDL[measurement of LDL cholesterol on a fasting blood test baseline and 12 months post baseline] Change in lipid profile‐ total cholesterol[measurement total cholesterol on a fasting blood test Baseline and 12 months post baseline] Changes in autonomic (sympathetic tone) as assessed by muscle nerve sympathetic activity (MNSA).[A subgroup of 10 patients in each group will undergo microneurography of the peroneal nerve to measure MNSA. Baseline and 12 months post baseline.] Changes in autonomic (sympathetic/parasympathetic) tone.[Heart rate (HR) and blood pressure (BP) variability. HR and BP will be measured continuously for 10 minutes with the subject resting. Electrocardiograph (ECG) will be recorded with standard chest electrodes and non‐invasive blood pressure will be recorded continuously from cuffs on the fingers (Nova, Finapres Medical Systems, The Netherlands). Additionally measures of heart rate variability will also be collected from the implantable cardiac monitor. Baseline and 12 months post baseline. ] Changes in blood pressure[BP will be measure by the study team at baseline and 12‐month post baseline study visits. These measurements will be performed using an automatic blood pressure cuff (ensuring the cuff is appropriately sized) with the patient seated quietly for 5 minutes prior with the arm resting at heart level. The measurements will be repeated 3 times and averaged. ; Blood pressure will also be recorded at three‐, six‐ and nine‐month time points, these blood pressure assessments can be done in person with a study team member, or participants can use their home BP monitor, or attend a local pharmacy/medical centre for BP check. Baseline, 3, 6, 9 and 12 months post baseline.] changes in body mass inde X(BMI)[measurement of height (using stadiometer) and weight (using digital weight scale) Baseline and 12 months post baseline.] Changes in cardiac structure and function[transthoracic echocardiogram Baseline and 12 months post baseline.] Depression[hospital anxiety and depression score (HADS) Baseline and 12 months post baseline] Healthcare utilisation including; hospital admissions, ED presentations, specialist or GP visits or phone calls, nurse visits or phone calls, procedures for AF (direct current cardioversion, AF ablation). Excluding a 4 week blanking period. [Patient reported healthcare utilisation recorded by a study investigator/research nurse at 3 monthly study visits. Baseline and 12 months post baseline.] Presence of diabetes or pre‐diabetes [Measurement of Hba1c on a blood test Baseline and 12 months post baseline.] Presence of diabetes or pre‐diabetes[random glucose on a fasting blood test baseline and 12 months post baseline ] Quality of life[AF effect on quality of life (AFEQT) questionnaire Baseline and 12 months post baseline. ] Quality of life[SF‐36 questionnaire Baseline and 12 months post baseline. ] Resting heart rate [HR recorded at study visits, HR information from implanted cardiac monitor. Baseline and 12 months post baseline.]
Epistemonikos ID: b4bc56ec68314ccaed59820b63be1bdc617ed6ae
First added on: Aug 28, 2024