HypertensionNCT02727140
Yoga as a Supportive Therapy for Patients With Hypertension
A study testing Yoga with Asana (yoga postures) and Yoga without Asana (yoga postures) in people with Hypertension, run by Universität Duisburg-Essen at 1 site in Germany.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Yoga with Asana (yoga postures) and Yoga without Asana (yoga postures)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteGermany
- Study dates
- May 2016to Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- essential Hypertension
- stable antihypertensive medication during the next 6 months
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
Essen
About this study
Official title: 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.
- Conditions
- Hypertension
- Being tested
- Yoga with Asana (yoga postures), Yoga without Asana (yoga postures)
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yoga with Asana (yoga postures)Behavioural
Yoga intervention consisting of asana, breathing and relaxation, meditation
Yoga without Asana (yoga postures)Behavioural
Yoga intervention without asanas, consisting only of breathing, relaxation and meditation
| Study group | Role | What they receive |
|---|---|---|
| Yoga with Asana (yoga postures) | Experimental | Not described Receives: Behavioral: Yoga with Asana (yoga postures) |
| Yoga without Asana (yoga postures) | Experimental | Not described Receives: Behavioral: Yoga without Asana (yoga postures) |
| Wait-list control group | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 h mean value of systolic and diastolic blood pressure
Measured: 12 weeks
Secondary outcomes (13)
24 h mean value of systolic and diastolic blood pressure
Measured: 28 weeks
Health-related Quality of Life
Short Form 36 Health Survey Questionnaire (SF-36)
Measured: 12 weeks
Health-related Quality of Life
Short Form 36 Health Survey Questionnaire (SF-36)
Measured: 28 weeks
Emotional Distress
Hospital Anxiety and Depression Scale (HADS)
Measured: 12 weeks
Emotional Distress
Hospital Anxiety and Depression Scale (HADS)
Measured: 28 weeks
Subjective Stress
Cohen Perceived Stress Scale (CPSS)
Measured: 12 weeks
Subjective Stress
Cohen Perceived Stress Scale (CPSS)
Measured: 28 weeks
Nutrition habits
Five a Day Food Frequency Questionnaire
Measured: 12 weeks
Nutrition habits
Five a Day Food Frequency Questionnaire
Measured: 28 weeks
Physical activity
Baecke Physical Activity Questionnaire
Measured: 12 weeks
Physical activity
Baecke Physical Activity Questionnaire
Measured: 28 weeks
Adverse Events
Measured: 12 weeks
Adverse Events
Measured: 28 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJan 2017
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universität Duisburg-Essen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Holger Cramer, Universität Duisburg-Essen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02727140
- Sponsor's protocol ID
- 15-6726-BO
- Status last verified
- May 2017
- First submitted
- 23 Mar 2016
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Yoga as a Supportive Therapy for Patients With Hypertension: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02727140
- Acronym / sponsor ID
- 15-6726-BO
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Universität Duisburg-EssenUniversity, hospital or other
- Study start
- May 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 4 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Yoga with Asana (yoga postures) | Experimental | Behavioral: Yoga with Asana (yoga postures) |
| Yoga without Asana (yoga postures) | Experimental | Behavioral: Yoga without Asana (yoga postures) |
| Wait-list control group | No intervention | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- essential Hypertension
- stable antihypertensive medication during the next 6 months
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yoga with Asana (yoga postures)Yoga intervention consisting of asana, breathing and relaxation, meditation | Behavioural | Yoga with Asana (yoga postures) |
| Yoga without Asana (yoga postures)Yoga intervention without asanas, consisting only of breathing, relaxation and meditation | Behavioural | Yoga without Asana (yoga postures) |
Primary outcome
24 h mean value of systolic and diastolic blood pressure
Time frame: 12 weeks
13 secondary outcomes
24 h mean value of systolic and diastolic blood pressure
Time frame: 28 weeks
Health-related Quality of Life
Time frame: 12 weeks
Health-related Quality of Life
Time frame: 28 weeks
Emotional Distress
Time frame: 12 weeks
Emotional Distress
Time frame: 28 weeks
Subjective Stress
Time frame: 12 weeks
Subjective Stress
Time frame: 28 weeks
Nutrition habits
Time frame: 12 weeks
Nutrition habits
Time frame: 28 weeks
Physical activity
Time frame: 12 weeks
Physical activity
Time frame: 28 weeks
Adverse Events
Time frame: 12 weeks
Adverse Events
Time frame: 28 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2017.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yoga with Asana (yoga postures) and Yoga without Asana (yoga postures) in people with Hypertension, run by Universität Duisburg-Essen at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 h mean value of systolic and diastolic blood pressure (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2017.