Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation

Paroxysmal Atrial Fibrillation Clinical Trial

Official title:

Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01789372
• Other study ID #: YOGAFF-001
• Status: Completed
• Phase: N/A
• First received: February 5, 2013
• Last updated: February 11, 2013
• Start date: December 2009
• Est. completion date: June 2012

Study information

• Verified date: February 2013
• Source: Danderyd Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Atrial Fibrillation
• Paroxysmal Atrial Fibrillation

Locations

Country	Name	City	State
Sweden	Danderyds hospital	Stockholm

Sponsors (1)

Lead Sponsor	Collaborator
Danderyd Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quality of life		Change from baseline in SF-36 after 12 weeks.Change from baseline in SF-36 after six months.	No
Primary	Quality of life		Change from baseline in SF-36 after 12 weeks.Change from baseline in EQ-5D after six month	No
Secondary	Blood pressure		Change from baseline in blood pressure after 12 weeks. Change from baseline in blood pressure after six months	No
Secondary	heart rate		Change from baseline in heart rate after 12 weeks.Change from baseline in heart rate after six months.	No
Secondary	Heart variability		Change from baseline in heart variability after 12 weeks.Change from baseline in heart variability after six months.	No