HypertensionNCT00328666
The Penn Lifestyle Modification and Blood Pressure Study
A study testing Iyengar yoga and Enhanced nutritional care classes in people with Hypertension, run by University of Pennsylvania at 1 site in United States.
Trial summary
The purpose of this study is to compare the effects of 12 weeks of structured classes of either iyengar yoga (IY) or an enhanced usual care intervention on blood pressure, heart rate variability, quality of life measures, lipid measures, and safety in patients with high-normal to stage I hypertension. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Iyengar yoga and Enhanced nutritional care classes
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2005to Jan 2007
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects must be willing to, and have the capacity for, giving written informed consent.
- Between the ages of 18 and 70
- Blood pressure (BP) criteria: systolic blood pressure (SBP) of > 130 but < 160 mm Hg and diastolic blood pressure (DBP) < 100 mmHg
- All subjects must be willing to comply with all study-related procedures.
Who cannot join
- Female subjects who are pregnant or post partum < 3 months
- Subjects currently taking blood pressure lowering medications or dietary supplements (magnesium, potassium, calcium > 1200 mg/day, fish oils > 2000 mg/day, ephedra, hawthorn, forskolin)
- Non-dominant arm circumference > 50 cm
- Subjects with body mass index (BMI) >= 40.0 or < 18.5 kg/m2
- Subjects who have practiced IY in the last 12 months or those who have practiced any form of yoga > 2 times (2x)/month in the previous 6 months.
- Subjects who have received an experimental drug, used an experimental medical device within 30 days prior to screening, or who gave a blood donation of greater than or equal to one pint within 8 weeks prior to screening.
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- Subjects with diabetes mellitus
- Subjects with established cardiovascular disease
- Subjects with known arrhythmias such as atrial flutter or fibrillation or those with cardiac pacemakers
- Current users (within the previous 30 days) of any tobacco products
- History of renal insufficiency based on estimated glomerular filtration rate < 60 ml/min
- Women who consume > 10 alcoholic drinks per week and men who consume > 15 drinks per week.
- Subjects with known autonomic neuropathy (e.g: Shy-Drager, orthostatic hypotension)
- Subjects with known secondary causes of hypertension (renal artery stenosis, pheochromocytoma, coarctation of aorta, hyperaldosteronemia)
- Regular use of benzodiazepines, anti-psychotic drugs or corticosteroids (> 1x per month). Stable doses (3 months) of antidepressants (selective serotonin reuptake inhibitors [SSRIs] or tricyclic antidepressants [TCAs]) will be allowed.
- Known severe musculoskeletal problems such as spinal stenosis that may limit participation in yoga
- Subjects who actively practice (> 2x/month) other mind-body therapy (MBT) such as Qigong, Tai Chi, or meditation.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Cardiovascular Effects of Iyengar Yoga vs. Enhanced Usual Care in Patients With High-normal to Stage I Hypertension
The purpose of this study is to compare the effects of 12 weeks of structured classes of either iyengar yoga (IY) or an enhanced usual care intervention on blood pressure, heart rate variability, quality of life measures, lipid measures, and safety in patients with high-normal to stage I hypertension.
Read the detailed description
This is a single site, parallel, non-blinded, randomized controlled trial to assess the safety and efficacy of 12 weeks of structured IY vs. enhanced usual care in adults with high-normal to stage I HTN. All potential subjects will be screened first by telephone and then by an outpatient visit at the General Clinical Research Center (GCRC) at either the hospital of the University of Pennsylvania (HUP) or the Presbyterian Medical Center (PMC). Eligible subjects will then make 4 visits to the GCRC where, during 3 visits, they will be admitted overnight to have non-invasive 24 hour recordings of blood pressure and heart rate variability as well as periodic blood and urine collections. In order to assess durability of biologic effects once the formal intervention is stopped, we added a 4 week follow up visit. The entire study duration is 18 weeks (16 weeks post-randomization) and includes a total of 5 visits. Subjects will be randomized to either the IYP or Blood Pressure Education Program (BPEP) which will be incorporated into off-site, small group classes.
- Conditions
- Hypertension
- Being tested
- Iyengar yoga, Enhanced nutritional care classes
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iyengar yogaBehavioural
Enhanced nutritional care classesBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
systolic blood pressure
Secondary outcomes (7)
heart rate variability
lipids
safety markers
quality of life measures
physiologic markers of stress
insulin resistance
pulse wave velocity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2006 (estimated)
- Study startFeb 2005
- Primary completionJan 2007
- Study completionJan 2007
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.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Responsible party
- Sponsor
- Investigators
- Raymond Townsend, MD, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00328666
- Sponsor's protocol ID
- 802058 LIMBS
- Other IDs
- NIH grant number AT002353-02
- Status last verified
- Nov 2015
- First submitted
- 18 May 2006
- Last updated
- 25 Nov 2015
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Effects of Iyengar Yoga vs. Enhanced Usual Care in Patients With High-normal to Stage I Hypertension
- ClinicalTrials.gov ID
- NCT00328666
- Acronym / sponsor ID
- 802058 LIMBS
- Conditions
- Hypertension
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH)
- Study start
- Feb 2005
- Primary completion
- Jan 2007 (actual)
- Study completion
- Jan 2007 (actual)
- First posted
- 22 May 2006 (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 purpose of this study is to compare the effects of 12 weeks of structured classes of either iyengar yoga (IY) or an enhanced usual care intervention on blood pressure, heart rate variability, quality of life measures, lipid measures, and safety in patients with high-normal to stage I hypertension.
Detailed description
This is a single site, parallel, non-blinded, randomized controlled trial to assess the safety and efficacy of 12 weeks of structured IY vs. enhanced usual care in adults with high-normal to stage I HTN. All potential subjects will be screened first by telephone and then by an outpatient visit at the General Clinical Research Center (GCRC) at either the hospital of the University of Pennsylvania (HUP) or the Presbyterian Medical Center (PMC). Eligible subjects will then make 4 visits to the GCRC where, during 3 visits, they will be admitted overnight to have non-invasive 24 hour recordings of blood pressure and heart rate variability as well as periodic blood and urine collections. In order to assess durability of biologic effects once the formal intervention is stopped, we added a 4 week follow up visit. The entire study duration is 18 weeks (16 weeks post-randomization) and includes a total of 5 visits. Subjects will be randomized to either the IYP or Blood Pressure Education Program (BPEP) which will be incorporated into off-site, small group classes.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects must be willing to, and have the capacity for, giving written informed consent.
- Between the ages of 18 and 70
- Blood pressure (BP) criteria: systolic blood pressure (SBP) of > 130 but < 160 mm Hg and diastolic blood pressure (DBP) < 100 mmHg
- All subjects must be willing to comply with all study-related procedures.
Key exclusion criteria (17 listed)
- Female subjects who are pregnant or post partum < 3 months
- Subjects currently taking blood pressure lowering medications or dietary supplements (magnesium, potassium, calcium > 1200 mg/day, fish oils > 2000 mg/day, ephedra, hawthorn, forskolin)
- Non-dominant arm circumference > 50 cm
- Subjects with body mass index (BMI) >= 40.0 or < 18.5 kg/m2
- Subjects who have practiced IY in the last 12 months or those who have practiced any form of yoga > 2 times (2x)/month in the previous 6 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 |
|---|---|---|
| Iyengar yoga | Behavioural | – |
| Enhanced nutritional care classes | Behavioural | – |
Primary outcome
systolic blood pressure
7 secondary outcomes
heart rate variability
lipids
safety markers
quality of life measures
physiologic markers of stress
insulin resistance
pulse wave velocity
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 25 Nov 2015.
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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.
Raymond Townsend, MD principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Iyengar yoga and Enhanced nutritional care classes in people with Hypertension, run by University of Pennsylvania at 1 site in United States.
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 4 inclusion and 17 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 25 Nov 2015. 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 United States. 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?
systolic blood pressure. 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 25 Nov 2015.