Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation-MYPAF

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Danderyd Hospital
Sponsor:
Collaborators:
Karolinska Institutet
Sophiahemmet University
Information provided by (Responsible Party):
Maria Nilsson, Danderyd Hospital
ClinicalTrials.gov Identifier:
NCT02223156
First received: August 21, 2014
Last updated: NA
Last verified: August 2014
History: No changes posted
  Purpose

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
Paroxysmal Atrial Fibrillation

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation-MYPAF, a Randomized Controlled Three Arms Study

Resource links provided by NLM:


Further study details as provided by Danderyd Hospital:

Primary Outcome Measures:
  • Quality of life [ Time Frame: Three months ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • heart rate variability [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Other Outcome Measures:
  • Episodes of arrythmia is decreasing [ Time Frame: three months ] [ Designated as safety issue: Yes ]

Biospecimen Retention:   Samples Without DNA

BNP and CRP


Estimated Enrollment: 132
Study Start Date: March 2014
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
MediYoga
Music relaxation
No treatment

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02223156

Locations
Sweden
Karolinska Institute Danderyd hospital Recruiting
Stockholm, Sweden
Contact: Maria Nilsson       maria.nilsson@ds.se   
Principal Investigator: Maria Nilsson, RN, Doctoral student         
Sponsors and Collaborators
Danderyd Hospital
Karolinska Institutet
Sophiahemmet University
Investigators
Principal Investigator: Monica Rydell-Karlsson, RN, PhD Sophiahemmet University, Stockholm
  More Information

No publications provided

Responsible Party: Maria Nilsson, RN, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT02223156     History of Changes
Other Study ID Numbers: DNR 2013/953-31/4
Study First Received: August 21, 2014
Last Updated: August 21, 2014
Health Authority: Sweden: The National Board of Health and Welfare

Additional relevant MeSH terms:
Atrial Fibrillation
Arrhythmias, Cardiac
Cardiovascular Diseases
Heart Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on April 23, 2015