Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation-MYPAF

Paroxysmal Atrial Fibrillation Clinical Trial

— MYPAF  

Official title:

Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation-MYPAF, a Randomized Controlled Three Arms Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02223156
• Other study ID #: DNR 2013/953-31/4
• Status: Recruiting
• Phase: N/A
• First received: August 21, 2014
• Last updated: August 21, 2014
• Start date: March 2014
• Est. completion date: December 2016

Study information

• Verified date: August 2014
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: The National Board of Health and Welfare
• Study type: Observational

Clinical Trial Summary

The main purpose of this study is to investigate effect of Medi Yoga on quality of life, biomedical factors and health care consumption, and to study gender differences between individuals diagnosed with paroxysmal atrial fibrillation (PAF). Furthermore, an additional purpose is to describe people's experiences of Medi Yoga and identify how Medi Yoga affects their condition.

Hypothesis Individuals with PAF exercising Medi Yoga improve their quality of life and blood pressure, heart rate and heart rate variability. Biological markers such as NT-proBNP and CRP are positively affected, and that individuals seek less medical care.

Description:

Methods / materials The chosen study design is a randomized Three arms controlled trial. The study will be conducted at the Cardiology Clinic at Danderyd Hospital in Stockholm. One hundred and thirty two individuals will be included and randomized to the intervention group (yoga), Music relaxation group or control group (usual follow-up). Inclusion criteria are the diagnosis of PAF and experience of symptomatic atrial fibrillation verified by ECG in the last six months. Exclusion criteria are language difficulties, multi-diagnosis and/or cognitive dysfunction (eg, diagnoses of mental illness, dementia) who are judged not to be able to perform yoga. Individuals with persistent or permanent atrial fibrillation are also excluded.

The subjects in the intervention group will practice yoga in groups for one hour once a week for 12 weeks in the hospital, with the guidance of a trained yoga instructor. They will receive written instructions on yoga exercises and a CD record to perform the yoga program at home. Added to that, the standard treatment i.e. drugs, cardioversion or ablation. The music relaxation group will listen to Music in half an hour in a group at the hospital.The control group receives usual care.

Participants are followed for three months and the evaluation is done at baseline and after three months. During these visits quality of life will be measured with two surveys, as well as variables such as blood pressure, heart rate, biological markers (CRP , BNP) , and ECG and 24-hour ECG . Primary endpoint: quality of life. In order to obtain a five -point difference in the quality of life, 132 subjects are required to achieve a power of 80 percent (p-value 0.05), including a loss rate of 20 percent. The calculation is based on the results of Substudy I. Analytical methods that will be used are: multivariate analyzes eg logistic regression, MANOVA, etc. and univariate analyzes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 132
• Est. completion date: December 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosis of PAF and experience of symptomatic atrial fibrillation verified by ECG in the last six months

Exclusion Criteria:

• language difficulties, multi-diagnosis and/or cognitive dysfunction (eg, diagnoses of mental illness, dementia) who are judged not to be able to perform yoga. Individuals with persistent or permanent atrial fibrillation are also excluded.

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Locations

Country	Name	City	State
Sweden	Karolinska Institute Danderyd hospital	Stockholm

Sponsors (3)

Lead Sponsor	Collaborator
Danderyd Hospital	Karolinska Institutet, Sophiahemmet University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Episodes of arrythmia is decreasing		three months	Yes
Primary	Quality of life		Three months	Yes
Secondary	heart rate variability		three months	Yes