HypertensionNCT01542359
Effectiveness of Yoga on Ambulatory Blood Pressure in Patients With Pre- and Stage I Hypertension
A study testing Yogic practice and Conventional Exercise in people with Hypertension, run by Long Island University at 1 site in United States.
Trial summary
The proposed study will compare a well defined and integrated yoga practice (postures/breath control/meditation) to a conventional exercise program in reducing hypertension. The expected outcomes include data on the effects of yoga on ambulatory blood pressure, psychosocial stress, and the autonomic system in… Read more about this study
- Who is it for?
- Ages 21 to 74 years
- Conditions the study is for
- Hypertension
- What is being tested?
- Yogic practice and Conventional Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to Oct 2012
- 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 21 to 74 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 21-64; Pre- or Stage I hypertension with mean office blood pressure (two measurements using aneroid sphygmomanometer) of systolic between 120 and 159 mmHg or Diastolic between less than or equal to 80 and 99 [1]
- Medically stable on any current medications; BMI (kg/m2) between 18.5 - 40
- English speaking
Who cannot join
- Taking anti-hypertensive medication; Current use of insulin or oral hypoglycemic agents
- Previous cardiovascular event (prior myocardial infarction, stroke, or angina pectoris)
- Current or previous cancer diagnosis
- Congestive heart failure
- History of kidney disease
- Signs or symptoms of significant peripheral vascular disease
- Significant co-morbidities that preclude successful completion of the study
- Yoga practitioner (participated in more than 3 yoga sessions within the last year)
Trial locations and contacts
1 site in 1 country.
About this study
The proposed study will compare a well defined and integrated yoga practice (postures/breath control/meditation) to a conventional exercise program in reducing hypertension. The expected outcomes include data on the effects of yoga on ambulatory blood pressure, psychosocial stress, and the autonomic system in individuals with pre- and Stage I hypertension. The information gained in this study will have a positive impact by providing critical preliminary and feasibility data to support a larger multi-ethnic randomized clinical trial on the effects of yoga on individuals with hypertension.
- Conditions
- Hypertension
- Being tested
- Yogic practice, Conventional Exercise
- Keywords
- Yoga, Hypertension, Blood Pressure, Autonomic Nervous system
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yogic practiceOther
breathing, meditation, physical postures
Conventional ExerciseOther
Standard physical exercises such as toe touch in standing, curl ups, push ups, leg lifts
| Study group | Role | What they receive |
|---|---|---|
| Yoga | Experimental | The integrated yoga program was designed to: 1) include the three primary elements of yoga as most commonly practiced in western cultures (physical postures, breath control and meditation); and 2) be appropriate for those without any prior yoga experience and with pre- and Stage I hypertension. The yoga program was designed by Eddie Stern, Founder and Director of "Ashtanga Yoga New York" (AYNY) in consultation with Drs. Hagins and Rundle, and are in large part congruent with the yoga program we studied previously (see Preliminary Studies). The yoga class includes: instruction on yogic principles regarding moral precepts (yamas and niyamas); active postures requiring mild-moderate physical exertion; conscious control of the breath in synchrony with active postures; and meditation. We expect approximately 10-15 minutes of the integrated yoga program to consist of isolated practice of meditation (occurring independently of the moving postures, typically in seated or lying positions). Receives: Other: Yogic practice |
| Conventional Exercise | Active comparator | Conventional exercise such as standing toe touch with arm swings, curl ups, push ups, leg lifts, etc. All done at a relatively slow rate which will be non-aerobic and at an average rate across the session of 3 METs Receives: Other: Conventional Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ambulatory Blood Pressure
24 hour ambulatory blood pressure: systolic, diastolic
Measured: Assessed within one week post a 12 week intervention
Secondary outcomes (1)
Psychosocial Stress
perceived stress, coping, tolerance of uncertainty, sense of control,
Measured: Assessed within one week after 12 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startSep 2011
- Primary completionOct 2012
- Study completionOct 2012
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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Long Island University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marshall Hagins, Long Island University
- Investigators
- Marshall A Hagins, PhD, PT, Principal investigator, Long Island University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542359
- Sponsor's protocol ID
- 1SC3GM088049-01A1 REVISED
- Other IDs
- 1SC3GM088049-01A1
- Status last verified
- Jan 2013
- First submitted
- 19 Feb 2012
- Last updated
- 10 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Yoga on Ambulatory Blood Pressure in Patients With Pre- and Stage I Hypertension
- ClinicalTrials.gov ID
- NCT01542359
- Acronym / sponsor ID
- 1SC3GM088049-01A1 REVISED
- Conditions
- Hypertension
- Keywords
- Yoga, Hypertension, Blood Pressure, Autonomic Nervous system
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Long Island UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 2 Mar 2012 (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 will compare a well defined and integrated yoga practice (postures/breath control/meditation) to a conventional exercise program in reducing hypertension. The expected outcomes include data on the effects of yoga on ambulatory blood pressure, psychosocial stress, and the autonomic system in individuals with pre- and Stage I hypertension. The information gained in this study will have a positive impact by providing critical preliminary and feasibility data to support a larger multi-ethnic randomized clinical trial on the effects of yoga on individuals with hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yoga | Experimental | Other: Yogic practiceThe integrated yoga program was designed to: 1) include the three primary elements of yoga as most commonly practiced in western cultures (physical postures, breath control and meditation); and 2) be appropriate for those without any prior yoga experience and with pre- and Stage I hypertension. The yoga program was designed by Eddie Stern, Founder and Director of "Ashtanga Yoga New York" (AYNY) in consultation with Drs. Hagins and Rundle, and are in large part congruent with the yoga program we studied previously (see Preliminary Studies). The yoga class includes: instruction on yogic principles regarding moral precepts (yamas and niyamas); active postures requiring mild-moderate physical exertion; conscious control of the breath in synchrony with active postures; and meditation. We expect approximately 10-15 minutes of the integrated yoga program to consist of isolated practice of meditation (occurring independently of the moving postures, typically in seated or lying positions). |
| Conventional Exercise | Active comparator | Other: Conventional ExerciseConventional exercise such as standing toe touch with arm swings, curl ups, push ups, leg lifts, etc. All done at a relatively slow rate which will be non-aerobic and at an average rate across the session of 3 METs |
Who may qualify
- Ages
- 21 to 74 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age: 21-64; Pre- or Stage I hypertension with mean office blood pressure (two measurements using aneroid sphygmomanometer) of systolic between 120 and 159 mmHg or Diastolic between less than or equal to 80 and 99 [1]
- Medically stable on any current medications; BMI (kg/m2) between 18.5 - 40
- English speaking
Key exclusion criteria (8 listed)
- Taking anti-hypertensive medication; Current use of insulin or oral hypoglycemic agents
- Previous cardiovascular event (prior myocardial infarction, stroke, or angina pectoris)
- Current or previous cancer diagnosis
- Congestive heart failure
- History of kidney disease
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 |
|---|---|---|
| Yogic practicebreathing, meditation, physical postures | Other | Yoga |
| Conventional ExerciseStandard physical exercises such as toe touch in standing, curl ups, push ups, leg lifts | Other | Conventional Exercise |
Primary outcome
Ambulatory Blood Pressure
Time frame: Assessed within one week post a 12 week intervention
24 hour ambulatory blood pressure: systolic, diastolic
1 secondary outcome
Psychosocial Stress
Time frame: Assessed within one week after 12 week intervention
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 10 Jan 2013.
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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.
Marshall A Hagins, PhD, PT principal investigator
Long Island University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yogic practice and Conventional Exercise in people with Hypertension, run by Long Island University 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 3 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 10 Jan 2013. 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?
Ambulatory Blood Pressure (time frame: Assessed within one week post a 12 week intervention). 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 10 Jan 2013.