Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation-MYPAF (MYPAF)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02223156|
Recruitment Status : Unknown
Verified August 2014 by Maria Nilsson, Danderyd Hospital.
Recruitment status was: Recruiting
First Posted : August 22, 2014
Last Update Posted : August 22, 2014
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.
|Condition or disease|
|Paroxysmal Atrial Fibrillation|
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|
|Estimated Enrollment :||132 participants|
|Observational Model:||Case Control|
|Official Title:||Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation-MYPAF, a Randomized Controlled Three Arms Study|
|Study Start Date :||March 2014|
|Estimated Primary Completion Date :||April 2016|
|Estimated Study Completion Date :||December 2016|
- Quality of life [ Time Frame: Three months ]
- heart rate variability [ Time Frame: three months ]
- Episodes of arrythmia is decreasing [ Time Frame: three months ]
Biospecimen Retention: Samples Without DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02223156
|Karolinska Institute Danderyd hospital||Recruiting|
|Contact: Maria Nilsson firstname.lastname@example.org|
|Principal Investigator: Maria Nilsson, RN, Doctoral student|
|Principal Investigator:||Monica Rydell-Karlsson, RN, PhD||Sophiahemmet University, Stockholm|