Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation-MYPAF (MYPAF)

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

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.

Study Overview

• Status: Unknown
• Conditions: Paroxysmal Atrial Fibrillation

Detailed 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.

• Study Type: Observational
• Enrollment (Anticipated): 132

Contacts and Locations

Study Locations

• Sweden
  • Stockholm, Sweden
    • Recruiting
    • Karolinska Institute Danderyd hospital
    • Contact: Maria Nilsson; Email: maria.nilsson@ds.se
    • Principal Investigator: Maria Nilsson, RN, Doctoral student

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Patients with diagnosis of paroxysmal atrial fibrillation will be identified from the list of patients scheduled for second visits at the Arrhythmia Polyclinic ("Arytmimottagningen") at the Cardiology Clinic, Danderyd Hospital. The selection will also be made from other hospitals in the Stockholm County Council.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
No treatment
MediYoga
Music relaxation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Quality of life	Three months

Secondary Outcome Measures

Outcome Measure	Time Frame
heart rate variability	three months

Other Outcome Measures

Outcome Measure	Time Frame
Episodes of arrythmia is decreasing	three months

Collaborators and Investigators

• Sponsor: Danderyd Hospital
• Collaborators: Karolinska Institutet; Sophiahemmet University
• Investigators: Principal Investigator: Monica Rydell-Karlsson, RN, PhD, Sophiahemmet University, Stockholm

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Anticipated): April 1, 2016
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: August 21, 2014
• First Submitted That Met QC Criteria: August 21, 2014
• First Posted (Estimate): August 22, 2014

Study Record Updates

• Last Update Posted (Estimate): August 22, 2014
• Last Update Submitted That Met QC Criteria: August 21, 2014
• Last Verified: August 1, 2014

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Arrhythmias, Cardiac; Atrial Fibrillation
• Other Study ID Numbers: DNR 2013/953-31/4