Effect of meditation combined with breathing technique on mental and exercise-induced hypertension

ISRCTN ISRCTN21417206
DOI https://doi.org/10.1186/ISRCTN21417206
Secondary identifying numbers N/A
Submission date
21/09/2005
Registration date
18/01/2006
Last edited
09/11/2009
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Circulatory System
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Wolfram Voelker
Scientific

Joseph-Schneider-Strasse 2
Wuerzburg
97070
Germany

Phone +49 931 201 36328
Email voelker_w@klinik.uni-wuerzburg.de

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymMeditation Study
Study objectivesMeditation in the Christian tradition combined with breathing techniques reduces ambulatory and stress-induced blood pressure in essential hypertension
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedEssential untreated hypertension
InterventionRandomisation 1:1 into meditation versus no meditation. The intervention consists of a four-week introductory course and a four-week intensive training phase. During these eight weeks, meditation in the Christian tradition and breathing techniques are taught by a certified meditation facilitator. Meditation sessions (40 minutes) are held daily as group meetings in the early evening. In addition, meditation is practiced daily individually at home in the morning. At baseline and after eight weeks, all participants undergo the following tests:
1. Standardised computerised mental stress test
2. Bicycle ergometry
3. 24 hour ambulatory blood pressure (BP) measurement
4. 24 hour Holter electrocardiogram (ECG)
5. Echocardiography
Intervention typeOther
Primary outcome measureMedian change in systolic BP during mental stress in the intervention group compared with controls.
Secondary outcome measures1. Median change in systolic and diastolic resting BP, during 24 hour ambulatory BP monitoring, exercise test (intervention group versus controls, respectively)
2. Difference in heart rate variability (Holter)
3. Diastolic function in echocardiography
Overall study start date01/03/2004
Completion date30/06/2004

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants52
Key inclusion criteria1. Age between 30 and 65 years
2. Written informed consent
3. Elevated resting blood pressure (more than 140/85 mmHg) on three occasions within four weeks
4. Primary hypertension confirmed by laboratory testing, clinical history and examination, abdominal ultrasound
Key exclusion criteria1. Previous training in contemplative meditation
2. Secondary hypertension
3. Blood pressure more than 180/110 mmHg
4. Antihypertensive therapy within the last 12 months
5. Pregnancy
6. Alcohol abuse
7. Immunosuppressive medication
8. Diabetes
Date of first enrolment01/03/2004
Date of final enrolment30/06/2004

Locations

Countries of recruitment

  • Germany

Study participating centre

Joseph-Schneider-Strasse 2
Wuerzburg
97070
Germany

Sponsor information

University of Wuerzburg (Germany)
University/education

Sanderring 2
Wuerzburg
97070
Germany

Phone +49 931 31 2231
Email kanzler@zv.uni-wuerzburg.de
ROR logo "ROR" https://ror.org/00fbnyb24

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/02/2008 Yes No