Yoga as a Supportive Therapy for Patients With Hypertension

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02727140
• Other study ID #: 15-6726-BO
• Status: Completed
• Phase: N/A
• First received: March 23, 2016
• Last updated: May 2, 2017
• Start date: May 2016
• Est. completion date: April 2017

Study information

• Verified date: May 2017
• Source: Universität Duisburg-Essen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: April 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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)

Related Conditions & MeSH terms

• Hypertension

Intervention

Behavioral:
• Yoga with Asana (yoga postures)
Yoga intervention consisting of asana, breathing and relaxation, meditation
• Yoga without Asana (yoga postures)
Yoga intervention without asanas, consisting only of breathing, relaxation and meditation

Locations

Country	Name	City	State
Germany	Department of Internal and Integrative Medicine, Kliniken Essen-Mitte	Essen

Sponsors (1)

Lead Sponsor	Collaborator
Universität Duisburg-Essen

Country where clinical trial is conducted

Germany, 

Outcome

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