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Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation

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ClinicalTrials.gov Identifier: NCT01789372
Recruitment Status : Completed
First Posted : February 12, 2013
Last Update Posted : February 12, 2013
Sponsor:
Information provided by (Responsible Party):
Maria Nilsson, Danderyd Hospital

Study Description
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Brief Summary:
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).

Condition or disease
Paroxysmal Atrial Fibrillation

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 Design
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Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation
Study Start Date : December 2009
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

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U.S. FDA Resources

Groups and Cohorts
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Outcome Measures
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Quality of life [ Time Frame: Change from baseline in SF-36 after 12 weeks.Change from baseline in SF-36 after six months. ]
  2. Quality of life [ Time Frame: Change from baseline in SF-36 after 12 weeks.Change from baseline in EQ-5D after six month ]

Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: Change from baseline in blood pressure after 12 weeks. Change from baseline in blood pressure after six months ]
  2. heart rate [ Time Frame: Change from baseline in heart rate after 12 weeks.Change from baseline in heart rate after six months. ]
  3. Heart variability [ Time Frame: Change from baseline in heart variability after 12 weeks.Change from baseline in heart variability after six months. ]

Eligibility Criteria
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT01789372


Locations
Sweden
Danderyds hospital
Stockholm, Sweden, 182 88
Sponsors and Collaborators
Danderyd Hospital
Investigators
Study Director: Viveka Frykman, Phd, MD Danderyd hospital, Karolinska Institute Sweden
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Maria Nilsson, Reg nurse, Danderyd Hospital
ClinicalTrials.gov Identifier: NCT01789372     History of Changes
Other Study ID Numbers: YOGAFF-001
First Posted: February 12, 2013    Key Record Dates
Last Update Posted: February 12, 2013
Last Verified: February 2013

Keywords provided by Maria Nilsson, Danderyd Hospital:
paroxysmal atrial fibrillation
yoga
quality of life
 blood pressure
heart rate
heart rate variability

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