Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Maria Nilsson, Danderyd Hospital

ClinicalTrials.gov Identifier:

NCT01789372

First received: February 5, 2013

Last updated: February 11, 2013

Last verified: February 2013

History of Changes

Purpose

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
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

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

Genetic and Rare Diseases Information Center resources: Familial Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Maria Nilsson, Danderyd Hospital:

Primary Outcome Measures:

Quality of life [ Time Frame: 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 ]

Secondary Outcome Measures:

Blood pressure [ Time Frame: 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. ]
Heart variability [ Time Frame: Change from baseline in heart variability after 12 weeks.Change from baseline in heart variability after six months. ]


Enrollment:	80
Study Start Date:	December 2009
Study Completion Date:	June 2012
Primary Completion Date:	June 2012 (Final data collection date for primary outcome measure)

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.

Eligibility


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

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: 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


Responsible Party:	Maria Nilsson, Reg nurse, Danderyd Hospital
ClinicalTrials.gov Identifier:	NCT01789372 History of Changes
Other Study ID Numbers:	YOGAFF-001
Study First Received:	February 5, 2013
Last Updated:	February 11, 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

ClinicalTrials.gov processed this record on June 26, 2017

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