Yoga as a Supportive Therapy for Patients With Hypertension

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

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 Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Yoga with Asana (yoga postures); Behavioral: Yoga without Asana (yoga postures)

• Study Type: Interventional
• Enrollment (Actual): 75
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Essen, Germany
    • Department of Internal and Integrative Medicine, Kliniken Essen-Mitte

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events		12 weeks
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		28 weeks

Collaborators and Investigators

• Sponsor: Universität Duisburg-Essen

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2016
• Primary Completion (Actual): January 1, 2017
• Study Completion (Actual): April 1, 2017

Study Registration Dates

• First Submitted: March 23, 2016
• First Submitted That Met QC Criteria: April 1, 2016
• First Posted (Estimate): April 4, 2016

Study Record Updates

• Last Update Posted (Actual): May 3, 2017
• Last Update Submitted That Met QC Criteria: May 2, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 15-6726-BO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO