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Completed

NCT Number: NCT02727140

Yoga as a Supportive Therapy for Patients With Hypertension

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.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Essen, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Yoga with Asana (yoga postures)

Behavioral

Yoga intervention consisting of asana, breathing and relaxation, meditation

Yoga without Asana (yoga postures)

Behavioral

Yoga intervention without asanas, consisting only of breathing, relaxation and meditation

Primary outcomes

  1. 24 h mean value of systolic and diastolic blood pressure

    Time frame: 12 weeks

Secondary outcomes

  1. 24 h mean value of systolic and diastolic blood pressure

    Time frame: 28 weeks

  2. Health-related Quality of Life

    Time frame: 12 weeks

    Short Form 36 Health Survey Questionnaire (SF-36)

  3. Health-related Quality of Life

    Time frame: 28 weeks

    Short Form 36 Health Survey Questionnaire (SF-36)

  4. Emotional Distress

    Time frame: 12 weeks

    Hospital Anxiety and Depression Scale (HADS)

  5. Emotional Distress

    Time frame: 28 weeks

    Hospital Anxiety and Depression Scale (HADS)

  6. Subjective Stress

    Time frame: 12 weeks

    Cohen Perceived Stress Scale (CPSS)

  7. Subjective Stress

    Time frame: 28 weeks

    Cohen Perceived Stress Scale (CPSS)

  8. Nutrition habits

    Time frame: 12 weeks

    Five a Day Food Frequency Questionnaire

  9. Nutrition habits

    Time frame: 28 weeks

    Five a Day Food Frequency Questionnaire

  10. Physical activity

    Time frame: 12 weeks

    Baecke Physical Activity Questionnaire

  11. Physical activity

    Time frame: 28 weeks

    Baecke Physical Activity Questionnaire

  12. Adverse Events

    Time frame: 12 weeks

  13. Adverse Events

    Time frame: 28 weeks

Sponsors and collaborators

Lead sponsor

Universität Duisburg-Essen

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 4, 2016
Registry last updated
May 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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