NCT02727140CompletedNot Applicable
Yoga as a Supportive Therapy for Patients With Hypertension: A Randomized Controlled Trial
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Universität Duisburg-Essen
- Enrollment
- 75
- Locations
- 1
- Primary Endpoint
- 24 h mean value of systolic and diastolic blood pressure
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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)
Arms & Interventions
Wait-list control group
No Intervention
Yoga with Asana (yoga postures)
Experimental
Intervention: Yoga with Asana (yoga postures) (Behavioral)
Yoga without Asana (yoga postures)
Experimental
Intervention: Yoga without Asana (yoga postures) (Behavioral)
Outcomes
Primary Outcomes
24 h mean value of systolic and diastolic blood pressure
Time Frame: 12 weeks
Secondary Outcomes
- Health-related Quality of Life(28 weeks)
- Subjective Stress(28 weeks)
- Adverse Events(28 weeks)
- 24 h mean value of systolic and diastolic blood pressure(28 weeks)
- Emotional Distress(28 weeks)
- Nutrition habits(28 weeks)
- Physical activity(28 weeks)
- Nutrition habits(12 weeks)
- Health-related Quality of Life(12 weeks)
- Emotional Distress(12 weeks)
- Subjective Stress(12 weeks)
- Physical activity(12 weeks)
- Adverse Events(12 weeks)
Investigators
Holger Cramer
Research director
Universität Duisburg-Essen
Study Sites (1)
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