Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000264583
Ethics application status
Approved
Date submitted
27/11/2023
Date registered
15/03/2024
Date last updated
15/03/2024
Date data sharing statement initially provided
15/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
A study of yoga for the management of atrial fibrillation
Scientific title
A randomised control study evaluating the effect of a yoga program on time to atrial fibrillation recurrence and atrial fibrillation burden in adults with paroxysmal or persistent atrial fibrillation.
Secondary ID [1] 311033 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
atrial fibrillation 332150 0
Condition category
Condition code
Cardiovascular 328871 328871 0 0
Other cardiovascular diseases
Physical Medicine / Rehabilitation 329647 329647 0 0
Other physical medicine / rehabilitation

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 327480 0
Lifestyle
Comparator / control treatment
Standard care as directed by treating physician, this may include medications and/or procedures such as direct current cardioversion for management of AF, as well as risk factor modification (weight loss, alcohol reduction, management of sleep apnoea etc...). Study investigators will discuss the importance of physical activity with control group participants and encourage them to undertake regular exercise of their choosing (other than yoga).
Control group
Active

Outcomes
Primary outcome [1] 336676 0
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.
Timepoint [1] 336676 0
Baseline and 12 months post baseline.
Primary outcome [2] 337433 0
AF burden at 12 months (excluding an initial 4-week blanking period)
Timepoint [2] 337433 0
Baseline and 12 months post baseline.
Secondary outcome [1] 431837 0
Quality of life
Timepoint [1] 431837 0
Baseline and 12 months post baseline.
Secondary outcome [2] 431838 0
Quality of life
Timepoint [2] 431838 0
Baseline and 12 months post baseline.
Secondary outcome [3] 431839 0
Anxiety
Timepoint [3] 431839 0
Baseline and 12 months post baseline.
Secondary outcome [4] 431840 0
Changes in autonomic (sympathetic/parasympathetic) tone.
Timepoint [4] 431840 0
Baseline and 12 months post baseline.
Secondary outcome [5] 431841 0
Changes in autonomic (sympathetic tone) as assessed by muscle nerve sympathetic activity (MNSA).
Timepoint [5] 431841 0
Baseline and 12 months post baseline.
Secondary outcome [6] 431842 0
Cardio-pulmonary fitness
Timepoint [6] 431842 0
Baseline and 12 months post baseline.
Secondary outcome [7] 431843 0
Changes in cardiac structure and function
Timepoint [7] 431843 0
Baseline and 12 months post baseline.
Secondary outcome [8] 431844 0
Changes in blood pressure
Timepoint [8] 431844 0
Baseline, 3, 6, 9 and 12 months post baseline.
Secondary outcome [9] 431845 0
changes in body mass index (BMI)
Timepoint [9] 431845 0
Baseline and 12 months post baseline.
Secondary outcome [10] 431846 0
Resting heart rate
Timepoint [10] 431846 0
Baseline and 12 months post baseline.
Secondary outcome [11] 431847 0
Change in lipid profile- total cholesterol
Timepoint [11] 431847 0
Baseline and 12 months post baseline
Secondary outcome [12] 431848 0
Presence of diabetes or pre-diabetes
Timepoint [12] 431848 0
Baseline and 12 months post baseline.
Secondary outcome [13] 431849 0
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.
Timepoint [13] 431849 0
Baseline and 12 months post baseline.
Secondary outcome [14] 432528 0
Change in lipid profile -HDL
Timepoint [14] 432528 0
baseline and 12 months post baseline
Secondary outcome [15] 432529 0
Change in lipid profile- LDL
Timepoint [15] 432529 0
baseline and 12 months post baseline
Secondary outcome [16] 432530 0
Change in lipid profile - triglycerides
Timepoint [16] 432530 0
baseline and 12 months post baseline
Secondary outcome [17] 432531 0
Presence of diabetes or pre-diabetes
Timepoint [17] 432531 0
baseline and 12 months post baseline
Secondary outcome [18] 432850 0
Depression
Timepoint [18] 432850 0
Baseline and 12 months post baseline

Eligibility
Key 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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
There are two primary endpoints; 1. AF recurrences at 12 months and 2. AF burden over 12 months. Due to these multiple primary endpoints an adjustment is needed to the type I error rate, hence an alpha level of 0.025 will be used for each outcome.
Based on previous studies of an exercise intervention and of an alcohol-abstinence intervention for AF, we anticipate a 20% difference in AF recurrence, with an 80% recurrence rate at 12 months in the control group and 60% in the yoga group. 99 participants will be required in each group to detect a 20% difference in AF recurrence with a power of 0.8 at an a of 0.025.
Based on data from prior studies we expect a median 1% difference in AF burden between the groups at 12 months. 111 participants will be required in each group to detect a 1% difference in AF burden at 12 months with a power of 0.8 at an a of 0.025.
Using the larger sample size estimate, and accounting for a 10% dropout, the required sample size is 244 participants (122 in each group).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
21/03/2024
Actual
Date of last participant enrolment
Anticipated
16/03/2026
Actual
Date of last data collection
Anticipated
22/03/2027
Actual
Sample size
Target
244
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 25883 0
The Alfred - Melbourne
Recruitment hospital [2] 25884 0
Cabrini Hospital - Malvern - Malvern
Recruitment hospital [3] 25885 0
Royal Melbourne Hospital - City campus - Parkville
Recruitment postcode(s) [1] 41716 0
3004 - Melbourne
Recruitment postcode(s) [2] 41718 0
3050 - Parkville
Recruitment postcode(s) [3] 41717 0
3144 - Malvern

Funding & Sponsors
Funding source category [1] 315864 0
Government body
Name [1] 315864 0
The National Health and Medical Research Council
Country [1] 315864 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
Commercial Rd Melbroune Victoria 3004
Country
Australia
Secondary sponsor category [1] 318003 0
None
Name [1] 318003 0
Address [1] 318003 0
Country [1] 318003 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314218 0
Alfred Hospital Ethics Committee
Ethics committee address [1] 314218 0
https://www.alfredhealth.org.au/research/ethics-research-governance
Ethics committee country [1] 314218 0
Australia
Date submitted for ethics approval [1] 314218 0
17/08/2023
Approval date [1] 314218 0
15/12/2023
Ethics approval number [1] 314218 0
529/23

Summary
Brief summary
The Yoga AF study will enrol patients with atrial fibrillation who are undergoing a rhythm control strategy (ie trying to maintain sinus rhythm, the hearts normal rhythm), half of the participants will be randomly chosen to undertake a yoga program, which we believe may help reduce the amount of AF a person has. The aim of the study is to assess the effect of participation in a regular yoga program to see if regular yoga can reduce the number of recurrences and overall amount of atrial fibrillation a person experiences.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130822 0
Prof Peter Kistler
Address 130822 0
The Heart Centre at the Alfred, Commercial Rd, Melbourne, Victoria, 3004
Country 130822 0
Australia
Phone 130822 0
+61 0390763263
Fax 130822 0
Email 130822 0
peter.kistler@baker.edu.au
Contact person for public queries
Name 130823 0
Dr Rose Crowley
Address 130823 0
The Heart Centre at the Alfred, Commercial Rd, Melbourne, Victoria, 3004
Country 130823 0
Australia
Phone 130823 0
+61400915584
Fax 130823 0
Email 130823 0
r.crowley@alfred.org.au
Contact person for scientific queries
Name 130824 0
Dr Rose Crowley
Address 130824 0
The Heart Centre at the Alfred, Commercial Rd, Melbourne, Victoria, 3004
Country 130824 0
Australia
Phone 130824 0
+61400915584
Fax 130824 0
Email 130824 0
r.crowley@alfred.org.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
21046Study protocol  r.crowley@alfred.org.au
21047Statistical analysis plan  r.crowley@alfred.org.au
21048Ethical approval  r.crowley@alfred.org.au



Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.