NCT01789372

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 12, 2013

Completed
Last Updated

February 12, 2013

Status Verified

February 1, 2013

Enrollment Period

2.5 years

First QC Date

February 5, 2013

Last Update Submit

February 11, 2013

Conditions

Paroxysmal Atrial Fibrillation

Keywords

paroxysmal atrial fibrillationyogaquality of lifeblood pressureheart rateheart rate variability

Outcome Measures

Primary Outcomes (2)

  • Quality of life

    Change from baseline in SF-36 after 12 weeks.Change from baseline in SF-36 after six months.

  • Quality of life

    Change from baseline in SF-36 after 12 weeks.Change from baseline in EQ-5D after six month

Secondary Outcomes (3)

  • Blood pressure

    Change from baseline in blood pressure after 12 weeks. Change from baseline in blood pressure after six months

  • heart rate

    Change from baseline in heart rate after 12 weeks.Change from baseline in heart rate after six months.

  • Heart variability

    Change from baseline in heart variability after 12 weeks.Change from baseline in heart variability after six months.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • Diagnosis of PAF

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danderyds hospital

Stockholm, 182 88, Sweden

Location

Related Publications (1)

  • Wahlstrom M, Medin J, Karlsson MR. Gender differences in health-related quality of life, blood pressure and heart rate among patients with paroxysmal atrial fibrillation after performing MediYoga. Int J Cardiol Heart Vasc. 2023 Sep 22;49:101274. doi: 10.1016/j.ijcha.2023.101274. eCollection 2023 Dec.

    PMID: 37766884DERIVED

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Viveka Frykman, Phd, MD

    Danderyd hospital, Karolinska Institute Sweden

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Reg nurse

Study Record Dates

First Submitted

February 5, 2013

First Posted

February 12, 2013

Study Start

December 1, 2009

Primary Completion

June 1, 2012

Study Completion

June 1, 2012

Last Updated

February 12, 2013

Record last verified: 2013-02

Locations

SE(1)