ANZCTR - Registration

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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]

nil known

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

atrial fibrillation

Condition category

Condition code

Cardiovascular

Other cardiovascular diseases

Physical Medicine / Rehabilitation

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]

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]

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]

Baseline and 12 months post baseline.

Primary outcome [2]

AF burden at 12 months (excluding an initial 4-week blanking period)

Timepoint [2]

Baseline and 12 months post baseline.

Secondary outcome [1]

Quality of life

Timepoint [1]

Baseline and 12 months post baseline.

Secondary outcome [2]

Quality of life

Timepoint [2]

Baseline and 12 months post baseline.

Secondary outcome [3]

Anxiety

Timepoint [3]

Baseline and 12 months post baseline.

Secondary outcome [4]

Changes in autonomic (sympathetic/parasympathetic) tone.

Timepoint [4]

Baseline and 12 months post baseline.

Secondary outcome [5]

Changes in autonomic (sympathetic tone) as assessed by muscle nerve sympathetic activity (MNSA).

Timepoint [5]

Baseline and 12 months post baseline.

Secondary outcome [6]

Cardio-pulmonary fitness

Timepoint [6]

Baseline and 12 months post baseline.

Secondary outcome [7]

Changes in cardiac structure and function

Timepoint [7]

Baseline and 12 months post baseline.

Secondary outcome [8]

Changes in blood pressure

Timepoint [8]

Baseline, 3, 6, 9 and 12 months post baseline.

Secondary outcome [9]

changes in body mass index (BMI)

Timepoint [9]

Baseline and 12 months post baseline.

Secondary outcome [10]

Resting heart rate

Timepoint [10]

Baseline and 12 months post baseline.

Secondary outcome [11]

Change in lipid profile- total cholesterol

Timepoint [11]

Baseline and 12 months post baseline

Secondary outcome [12]

Presence of diabetes or pre-diabetes

Timepoint [12]

Baseline and 12 months post baseline.

Secondary outcome [13]

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]

Baseline and 12 months post baseline.

Secondary outcome [14]

Change in lipid profile -HDL

Timepoint [14]

baseline and 12 months post baseline

Secondary outcome [15]

Change in lipid profile- LDL

Timepoint [15]

baseline and 12 months post baseline

Secondary outcome [16]

Change in lipid profile - triglycerides

Timepoint [16]

baseline and 12 months post baseline

Secondary outcome [17]

Presence of diabetes or pre-diabetes

Timepoint [17]

baseline and 12 months post baseline

Secondary outcome [18]

Depression

Timepoint [18]

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?

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]

The Alfred - Melbourne

Recruitment hospital [2]

Cabrini Hospital - Malvern - Malvern

Recruitment hospital [3]

Royal Melbourne Hospital - City campus - Parkville

Recruitment postcode(s) [1]

3004 - Melbourne

Recruitment postcode(s) [2]

3144 - Malvern

Recruitment postcode(s) [3]

3050 - Parkville

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

The National Health and Medical Research Council

Address [1]

Country [1]

Australia

Primary sponsor type

Hospital

Name

Alfred Health

Address

Commercial Rd Melbroune Victoria 3004

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Hospital Ethics Committee

Ethics committee address [1]

https://www.alfredhealth.org.au/research/ethics-research-governance

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

17/08/2023

Approval date [1]

15/12/2023

Ethics approval number [1]

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

Prof Peter Kistler

Address

The Heart Centre at the Alfred, Commercial Rd, Melbourne, Victoria, 3004

Country

Australia

Phone

+61 0390763263

Fax

[email protected]

Contact person for public queries

Name

Rose Crowley

Address

The Heart Centre at the Alfred, Commercial Rd, Melbourne, Victoria, 3004

Country

Australia

Phone

+61400915584

Fax

[email protected]

Contact person for scientific queries

Name

Rose Crowley

Address

The Heart Centre at the Alfred, Commercial Rd, Melbourne, Victoria, 3004

Country

Australia

Phone

+61400915584

Fax

[email protected]

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Email
21046	Study protocol	[email protected]
21047	Statistical analysis plan	[email protected]
21048	Ethical approval	[email protected]

Results publications and other study-related documents

Documents added manually

No documents have been uploaded by study researchers.

Documents added automatically

No additional documents have been identified.

Trial Review

Documents added manually

Documents added automatically