Yoga as a Supportive Therapy for Patients With Hypertension
1 other identifier
interventional
75
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable hypertension
Started May 2016
Shorter than P25 for not_applicable hypertension
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2016
CompletedFirst Posted
Study publicly available on registry
April 4, 2016
CompletedStudy Start
First participant enrolled
May 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedMay 3, 2017
May 1, 2017
8 months
March 23, 2016
May 2, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
24 h mean value of systolic and diastolic blood pressure
12 weeks
Secondary Outcomes (13)
24 h mean value of systolic and diastolic blood pressure
28 weeks
Health-related Quality of Life
12 weeks
Health-related Quality of Life
28 weeks
Emotional Distress
12 weeks
Emotional Distress
28 weeks
- +8 more secondary outcomes
Study Arms (3)
Yoga with Asana (yoga postures)
EXPERIMENTALYoga without Asana (yoga postures)
EXPERIMENTALWait-list control group
NO INTERVENTIONInterventions
Yoga intervention consisting of asana, breathing and relaxation, meditation
Yoga intervention without asanas, consisting only of breathing, relaxation and meditation
Eligibility Criteria
You may qualify if:
- essential Hypertension
- stable antihypertensive medication during the next 6 months
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen, Germany
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Research director
Study Record Dates
First Submitted
March 23, 2016
First Posted
April 4, 2016
Study Start
May 1, 2016
Primary Completion
January 1, 2017
Study Completion
April 1, 2017
Last Updated
May 3, 2017
Record last verified: 2017-05
Data Sharing
- IPD Sharing
- Will not share