NCT02223156

Brief Summary

The main purpose of this study is to investigate effect of Medi Yoga on quality of life, biomedical factors and health care consumption, and to study gender differences between individuals diagnosed with paroxysmal atrial fibrillation (PAF). Furthermore, an additional purpose is to describe people's experiences of Medi Yoga and identify how Medi Yoga affects their condition. Hypothesis Individuals with PAF exercising Medi Yoga improve their quality of life and blood pressure, heart rate and heart rate variability. Biological markers such as NT-proBNP and CRP are positively affected, and that individuals seek less medical care.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2014

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

March 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

August 21, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 22, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2016

Completed
Last Updated

August 22, 2014

Status Verified

August 1, 2014

Enrollment Period

2.1 years

First QC Date

August 21, 2014

Last Update Submit

August 21, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • Quality of life

    Three months

Secondary Outcomes (1)

  • heart rate variability

    three months

Other Outcomes (1)

  • Episodes of arrythmia is decreasing

    three months

Study Arms (3)

MediYoga

Music relaxation

No treatment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with diagnosis of paroxysmal atrial fibrillation will be identified from the list of patients scheduled for second visits at the Arrhythmia Polyclinic ("Arytmimottagningen") at the Cardiology Clinic, Danderyd Hospital. The selection will also be made from other hospitals in the Stockholm County Council.

You may qualify if:

  • diagnosis of PAF and experience of symptomatic atrial fibrillation verified by ECG in the last six months

You may not qualify if:

  • language difficulties, multi-diagnosis and/or cognitive dysfunction (eg, diagnoses of mental illness, dementia) who are judged not to be able to perform yoga. Individuals with persistent or permanent atrial fibrillation are also excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karolinska Institute Danderyd hospital

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

BNP and CRP

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Monica Rydell-Karlsson, RN, PhD

    Sophiahemmet University, Stockholm

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

August 21, 2014

First Posted

August 22, 2014

Study Start

March 1, 2014

Primary Completion

April 1, 2016

Study Completion

December 1, 2016

Last Updated

August 22, 2014

Record last verified: 2014-08

Locations