Impact of Yoga on Blood Pressure, Quality of Life and Stress in Patients With Hypertension

NCT ID: NCT01984593

Last Updated: 2014-11-05

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 190 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2014-03-31

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.

Conditions

Hypertension

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 group.

Group Type: NO_INTERVENTION

No interventions assigned to this group

yoga

Two yoga exercises to perform at home 15 minutes twice daily.

Group Type: ACTIVE_COMPARATOR

Yoga

Intervention Type: OTHER

The participants in the Yoga group will get a private doctors appointment (20 minutes) where they get instructions for two yoga exercises to perform at home 15 minutes twice a day.

The two yoga exercises were:

1. "Left nostril breathing" - deep breaths in and out through the left nostril while sitting or lying down, with the right nostril closed off by the right thumb or an earplug (about 11 minutes); and

2. "Spinal flex" - movement that alternates between flexing the spine forwards (arching) and relaxing the spine back in time with deep breaths while sitting in a chair (about 4 minutes).

Interventions

Yoga

The participants in the Yoga group will get a private doctors appointment (20 minutes) where they get instructions for two yoga exercises to perform at home 15 minutes twice a day.

The two yoga exercises were:

1. "Left nostril breathing" - deep breaths in and out through the left nostril while sitting or lying down, with the right nostril closed off by the right thumb or an earplug (about 11 minutes); and

2. "Spinal flex" - movement that alternates between flexing the spine forwards (arching) and relaxing the spine back in time with deep breaths while sitting in a chair (about 4 minutes).

Intervention Type: OTHER

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Swedish Research Council

OTHER_GOV

Sponsor Role: collaborator

Region Skane

OTHER

Sponsor Role: lead

Responsible Party

Moa Wolff

General Practitioner

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Moa Wolff, MD

Role: PRINCIPAL_INVESTIGATOR

Center for Primary Health Care Research, Lunds University

Locations

Center for Primary Health Care Research, Lunds University

Malmo, , Sweden

Countries

Sweden

Other Identifiers

Region Skane

Identifier Type: -

Identifier Source: org_study_id