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

February 22, 2011
February 22, 2012
March 2011
June 2011   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01302535 on ClinicalTrials.gov Archive Site
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.
Same as current
Not Provided
Not Provided
 
The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension
The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension - a Randomised Controlled Trial in Primary Health Care

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Hypertension
  • 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.
  • 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.
  • Active Comparator: Yoga group with supervision/trainer
    Intervention: Other: Yoga group with supervision (trainer)
  • Active Comparator: Yoga at home
    Intervention: Other: Yoga at home
  • 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.
Wolff M, Sundquist K, Larsson Lönn S, Midlöv P. Impact of yoga on blood pressure and quality of life in patients with hypertension - a controlled trial in primary care, matched for systolic blood pressure. BMC Cardiovasc Disord. 2013 Dec 7;13:111. doi: 10.1186/1471-2261-13-111.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
83
June 2011
June 2011   (final data collection date for primary outcome measure)

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
Both
up to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Sweden
 
NCT01302535
2010/728
No
Moa Wolff, Region Skane
Region Skane
The Swedish Research Council
Principal Investigator: Moa Wolff, MD Center for Primary Health Care Research, Lunds University
Region Skane
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP