Clinical trial NCT01984593: Impact of Yoga on Blood Pressure, Quality of Life and Stress in Patients With Hypertension
Official title: Impact of Yoga on Blood Pressure, Quality of Life and Stress in Patients With Hypertension - A Randomized Controlled Multicenter Trial in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Yoga
Hypertension
Quality of Life
Primary Health Care
Stress
Anxiety
Depression
Lead sponsor: Region Skane
Sponsor class: OTHER
Collaborators: name: The Swedish Research Council
First posted: 2013-11-14
Enrollment: 190
Sex: ALL
Minimum age (years): 30
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine the effects of a short yoga program practiced daily at home on blood pressure, quality of Life and stress. The subjects of the study are primary health care patients diagnosed with hypertension, with or without current medication.

Detailed description: Hypertension is one of the most common diseases in the world, affecting approximately 26% of the adult population. Persistent hypertension increases the risk of developing coronary heart disease, stroke and other cardiovascular diseases, such as heart failure. Hypertension is a common diagnosis in primary health care and the societal costs of examination and treatment of hypertension and its consequences are considerable.

The YHIP-study (The Impact of Yoga on Blood Pressure and Quality of Life in Patients With Hypertension), that investigated yoga as additional treatment for hypertension on primary care patients, showed that a short yoga program practiced daily at home had a blood pressure lowering effect as well as a positive effect on self-rated quality of life compared to control.

Other previous studies have demonstrated positive effects of yoga on blood pressure, quality of life, subjective well-being and stress. However, these studies are relatively few and we need to further investigate the possibility of using yoga as a treatment in primary health care.

If the yoga intervention shows to be effective, yoga exercises may be useful as a supplementary BP therapy in addition to medical treatment when prescribed by primary care physicians. It is to be hoped that patients will also experience a higher quality of life and less stress if they perform yoga on a regular basis.

Eligibility criteria: Inclusion Criteria:

* 30-80 years old
* Diagnosed with hypertension since at least one year
* Blood pressure 130-160 mm Hg systolic and/or 85-100 diastolic at the last blood pressure control by doctor or nurse.
* Blood pressure within inclusion- and exclusion-limits at baseline control

Exclusion Criteria:

* Blood pressure outside the range of 120-180 systolic and 80-110 diastolic at the last blood pressure control or at baseline control.
* 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

Primary outcomes:
measure: Hypertension
timeFrame: 12 weeks
Secondary outcomes:
measure: Quality of life
timeFrame: 12 weeks
Other outcomes:
measure: Stress
timeFrame: 12 weeks
measure: Anxiety and depression
timeFrame: 12 weeks
Locations:
city: Malmö
country: Sweden
facility: Center for Primary Health Care Research, Lunds University
Study officials:
affiliation: Center for Primary Health Care Research, Lunds University
name: Moa Wolff, MD
role: PRINCIPAL_INVESTIGATOR
References: