Yoga as a Supportive Therapy for Patients With Hypertension

Study Overview
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Brief Summary
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The proposed study aims to investigate the feasibility, effectiveness, and perceived benefit of a supportive hatha yoga intervention for patients with hypertension using antihypertensive drugs. Patients will be randomized into 3 groups comparing hatha yoga with yoga postures, breathing and relaxation techniques to a hatha yoga intervention without yoga postures (only breathing and relaxation techniques) as well as to a wait list control group.

Official Title
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Yoga as a Supportive Therapy for Patients With Hypertension: A Randomized Controlled Trial

Conditions
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Hypertension

Intervention / Treatment
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* Behavioral: Yoga with Asana (yoga postures)
* Behavioral: Yoga without Asana (yoga postures)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: essential Hypertension stable antihypertensive medication during the next 6 months Exclusion Criteria: pregnancy or breast feeding simultaneous participation in further clinical intervention trials regular yoga practice in the past 12 months serious mental illness (severe depression, severe addiction, psychosis) manifest coronary heart disease that has been treated in the past 3 months or myocardial infarction, embolism of pulmonary arteries or stroke in the past 3 months heart failure ≥ state 1 New York Heart Association (NYHA) peripheral arterial occlusive disease ≥ state 1 renal insufficiency > state 2, glomerular filtration rate < 60 ml/min/1,73m² according to he National Kidney Foundation (NKF)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga with Asana (yoga postures)<br> | Behavioral: Yoga with Asana (yoga postures)<br>* Yoga intervention consisting of asana, breathing and relaxation, meditation<br>|
| Experimental: Yoga without Asana (yoga postures)<br> | Behavioral: Yoga without Asana (yoga postures)<br>* Yoga intervention without asanas, consisting only of breathing, relaxation and meditation<br>|
| No Intervention: Wait-list control group<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 h mean value of systolic and diastolic blood pressure |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24 h mean value of systolic and diastolic blood pressure |  | 28 weeks | 
| Health-related Quality of Life | Short Form 36 Health Survey Questionnaire (SF-36) | 12 weeks | 
| Health-related Quality of Life | Short Form 36 Health Survey Questionnaire (SF-36) | 28 weeks | 
| Emotional Distress | Hospital Anxiety and Depression Scale (HADS) | 12 weeks | 
| Emotional Distress | Hospital Anxiety and Depression Scale (HADS) | 28 weeks | 
| Subjective Stress | Cohen Perceived Stress Scale (CPSS) | 12 weeks | 
| Subjective Stress | Cohen Perceived Stress Scale (CPSS) | 28 weeks | 
| Nutrition habits | Five a Day Food Frequency Questionnaire | 12 weeks | 
| Nutrition habits | Five a Day Food Frequency Questionnaire | 28 weeks | 
| Physical activity | Baecke Physical Activity Questionnaire | 12 weeks | 
| Physical activity | Baecke Physical Activity Questionnaire | 28 weeks | 
| Adverse Events |  | 12 weeks | 
| Adverse Events |  | 28 weeks |