Paroxysmal Atrial FibrillationNCT01789372
Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation
An observational study of Paroxysmal Atrial Fibrillation, run by Danderyd Hospital at 1 site in Sweden.
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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Paroxysmal Atrial Fibrillation
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2009to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Primary care clinic. All participants should have been on usual treatment (medication, cardio version or ablation) for at least three months.
Who may be able to join
- Diagnosis of PAF
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read the 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.
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- paroxysmal atrial fibrillation, yoga, quality of life, blood pressure, heart rate, heart rate variability
- Medical subject headings
- Atrial Fibrillation
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of life
Measured: Change from baseline in SF-36 after 12 weeks.Change from baseline in SF-36 after six months.
Quality of life
Measured: Change from baseline in SF-36 after 12 weeks.Change from baseline in EQ-5D after six month
Secondary outcomes (3)
Blood pressure
Measured: Change from baseline in blood pressure after 12 weeks. Change from baseline in blood pressure after six months
heart rate
Measured: Change from baseline in heart rate after 12 weeks.Change from baseline in heart rate after six months.
Heart variability
Measured: Change from baseline in heart variability after 12 weeks.Change from baseline in heart variability after six months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2013 (estimated)
- Study startDec 2009
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Paroxysmal Atrial FibrillationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danderyd Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Maria Nilsson, Danderyd Hospital
- Investigators
- Viveka Frykman, Phd, MD, Study director, Danderyd hospital, Karolinska Institute Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01789372
- Sponsor's protocol ID
- YOGAFF-001
- Status last verified
- Feb 2013
- First submitted
- 5 Feb 2013
- Last updated
- 12 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 37766884
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Mediyoga in Patients With Paroxysmal Atrial Fibrillation
- ClinicalTrials.gov ID
- NCT01789372
- Acronym / sponsor ID
- YOGAFF-001
- Conditions
- Paroxysmal Atrial Fibrillation
- Keywords
- paroxysmal atrial fibrillation, yoga, quality of life, blood pressure, heart rate, heart rate variability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Danderyd HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 12 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Primary care clinic. All participants should have been on usual treatment (medication, cardio version or ablation) for at least three months.
Key inclusion criteria (1 listed)
- Diagnosis of PAF
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2013.
- Derived from this study: PubMed 37766884Wahlstrom 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Viveka Frykman, Phd, MD study director
Danderyd hospital, Karolinska Institute Sweden
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paroxysmal Atrial Fibrillation, run by Danderyd Hospital at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quality of life (time frame: Change from baseline in SF-36 after 12 weeks.Change from baseline in SF-36 after six months.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01789372, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Feb 2013.