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
  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:


Further study details as provided by 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. ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Change from baseline in SF-36 after 12 weeks.Change from baseline in EQ-5D after six month ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • heart rate [ Time Frame: Change from baseline in heart rate after 12 weeks.Change from baseline in heart rate after six months. ] [ Designated as safety issue: No ]
  • Heart variability [ Time Frame: Change from baseline in heart variability after 12 weeks.Change from baseline in heart variability after six months. ] [ Designated as safety issue: No ]

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

Genders Eligible for Study:   Both
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

No publications provided

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
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by 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 October 19, 2014