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The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension (YHIP)

This study has been completed.
Sponsor:
Collaborator:
The Swedish Research Council
Information provided by (Responsible Party):
Moa Wolff, Region Skane
ClinicalTrials.gov Identifier:
NCT01302535
First received: February 22, 2011
Last updated: February 22, 2012
Last verified: February 2012
History of Changes
  Purpose

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.


Condition Intervention
Hypertension
 Other: Yoga group with supervision (trainer)
Other: Yoga at home

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension - a Randomised Controlled Trial in Primary Health Care

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Region Skane:

Primary Outcome Measures:
  • Hypertension [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 83
Study Start Date: March 2011
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Yoga group with supervision/trainer 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.
Active Comparator: Yoga at home Other: 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.
No Intervention: Control
No changes will be made for the participants in the control group, but they will undergo the same measurements and evaluations as the intervention groups.

Detailed 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.

  Eligibility

Ages Eligible for Study:   up to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01302535

Locations
Sweden
Center for Primary Health Care Research, Lunds University
Malmö, Sweden, 20502
Sponsors and Collaborators
Region Skane
The Swedish Research Council
Investigators
Principal Investigator: Moa Wolff, MD Center for Primary Health Care Research, Lunds University
  More Information

No publications provided

Responsible Party: Moa Wolff, General practitioner, Region Skane
ClinicalTrials.gov Identifier: NCT01302535     History of Changes
Other Study ID Numbers: 2010/728
Study First Received: February 22, 2011
Last Updated: February 22, 2012
Health Authority: Sweden: Regional Ethical Review Board

Keywords provided by Region Skane:
Yoga
Hypertension
Quality of Life
Primary Health Care

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on June 18, 2013