Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation

February 11, 2013 updated by: Maria Nilsson, Danderyd Hospital
The purpose of this study is to determinate if mediyoga has effects in quality of life, heart rate variability, blood pressure , heart rate in patients with paroxysmal atrial fibrillation (PAF).

Study Overview

Status

Completed

Conditions

Detailed Description

This is randomized prospective pilot study. Eighty patients from Danderyd hospital, Stockholm, Sweden were randomized to either mediyoga group or control group. The mediyoga group were completing yoga for one hour, once a week for 12 weeks together with usual treatment. The controlgroup had only usual treatment.The usual treatment consists of pharmaceutical, cardio version and ablation. Quality of life ( SF-36, EQ-5d), blood pressure, heart rate and 24-hours ekokardiografi were measured at baseline and after twelve weeks.A follow up after six months was accomplished with SF-36 and EQ-5d, bloodpressure and heart rate.

Study Type

Observational

Enrollment (Actual)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Stockholm, Sweden, 182 88
        • Danderyds Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Primary care clinic. All participants should have been on usual treatment (medication, cardio version or ablation) for at least three months.

Description

Inclusion Criteria:

  • Diagnosis of PAF

Exclusion Criteria:

  • The exclusions criteria were multiple concurrent medical conditions and/or cognitive dysfunction (in the diagnosis of e.g. mental illness), considered not to be able to carry out yoga owing to ability to move and those who have difficulties to understand the Swedish language.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Quality of life
Time Frame: Change from baseline in SF-36 after 12 weeks.Change from baseline in SF-36 after six months.
Change from baseline in SF-36 after 12 weeks.Change from baseline in SF-36 after six months.
Quality of life
Time Frame: Change from baseline in SF-36 after 12 weeks.Change from baseline in EQ-5D after six month
Change from baseline in SF-36 after 12 weeks.Change from baseline in EQ-5D after six month

Secondary Outcome Measures

Outcome Measure
Time Frame
Blood pressure
Time Frame: Change from baseline in blood pressure after 12 weeks. Change from baseline in blood pressure after six months
Change from baseline in blood pressure after 12 weeks. Change from baseline in blood pressure after six months
heart rate
Time Frame: Change from baseline in heart rate after 12 weeks.Change from baseline in heart rate after six months.
Change from baseline in heart rate after 12 weeks.Change from baseline in heart rate after six months.
Heart variability
Time Frame: Change from baseline in heart variability after 12 weeks.Change from baseline in heart variability after six months.
Change from baseline in heart variability after 12 weeks.Change from baseline in heart variability after six months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Danderyd Hospital

Investigators

  • Study Director: Viveka Frykman, Phd, MD, Danderyd hospital, Karolinska Institute Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2009

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

February 5, 2013

First Submitted That Met QC Criteria

February 11, 2013

First Posted (Estimate)

February 12, 2013

Study Record Updates

Last Update Posted (Estimate)

February 12, 2013

Last Update Submitted That Met QC Criteria

February 11, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YOGAFF-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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