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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01302535
Other study ID # 2010/728
Secondary ID
Status Completed
Phase N/A
First received February 22, 2011
Last updated February 22, 2012
Start date March 2011
Est. completion date June 2011

Study information

Verified date February 2012
Source Region Skane
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Interventional

Clinical Trial Summary

The purpose of this study is to determine the effects of yoga on blood pressure and quality of life in patients in primary health care diagnosed with hypertension within the last year. Another purpose is to examine whether the possible effect on blood pressure differs if patients practice yoga in a group lead by a yoga-trainer or receive a few yoga-exercises from their doctor to be practiced individually at home.


Description:

Hypertension is one of the most common diseases in the industrialized world. In Sweden alone approximately 1.8 million persons, 25% of the adult population, have hypertension. Hypertension is a common diagnosis in primary health care and the costs of investigating and treating hypertension and its consequences are considerable. We know that stress can affect blood pressure, but it is hard to measure and control.

Previous studies have separately shown that yoga can reduce levels of cortisol in saliva and lower blood pressure. However, few studies have investigated the effects of yoga on hypertension and we lack information about the possibility of using yoga in primary health care to reduce hypertension.

If yoga can be used to complement antihypertensive medicines, it could reduce medicine intake and thereby possibly reduce side effects and lower medicine costs. It is to be hoped that patients will also experience a higher quality of life if they perform yoga on a regular basis.


Recruitment information / eligibility

Status Completed
Enrollment 83
Est. completion date June 2011
Est. primary completion date June 2011
Accepts healthy volunteers No
Gender Both
Age group N/A to 80 Years
Eligibility Inclusion Criteria:

- Diagnosed with hypertension since at least one year.

- Blood pressure 120/80-160/100 mmHg at the last blood pressure control by doctor or nurse.

Exclusion Criteria:

- Blood pressure >180 systolic and/or >110 diastolic by the initial control in the study.

- Blood pressure <120 systolic by the initial control in the study.

- Medical adjustments regarding hypertension within 4 weeks prior to begin of study.

- Expected inability to understand instructions about yoga exercises (e.g dementia and mental retardation) or physical or psychical inability to carry out yoga exercises (e.g severe physical or psychical handicap).

- Need for interpreter. Linguistic/language difficulties

- Older than 80 years

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
Yoga group with supervision (trainer)
The Yoga-with-trainer group will meet once a week (60 minutes) to practice yoga with a yoga instructor. The participants will be encouraged to practice yoga between the yoga classes at home for 30 minutes a day.
Yoga at home
The participants in the Yoga-at-home group will get a private doctor appointment (20 minutes) where they get instructions for two yoga exercises which they are encouraged to perform at home 15 minutes a day.

Locations

Country Name City State
Sweden Center for Primary Health Care Research, Lunds University Malmö

Sponsors (2)

Lead Sponsor Collaborator
Region Skane The Swedish Research Council

Country where clinical trial is conducted

Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hypertension At the beginning of the study, all subjects will undergo a standardized blood pressure test with an hypertension monitor. After 12 weeks, all subjects in the intervention and control groups will again be requested to attend a blood pressure testing session. Blood samples will also be collected and analysed in the beginning and at the end of the study. Some blood samples will be preserved for future analysis. 12 weeks No
Secondary Quality of life At the beginning of the study, all subjects will be requested to fill in a questionnaire about their quality of life (WHOQOL-BREF). After 12 weeks all subjects in the intervention and control groups will fill in the quality of life-form for a second time. 12 weeks No
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