HypertensionPhase 2NCT00179543
Mechanisms and Therapeutic Effects of the Relaxation Response in Elderly Hypertensive Patients
A Phase 2 study testing Relaxation response in people with Hypertension, run by Beth Israel Deaconess Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to determine whether the relaxation response is more effective than attention control in reducing blood pressure and medication dosage in elderly adults with isolated systolic hypertension. Read more about this study
- Who is it for?
- Ages 55 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- Relaxation response
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2001to not given
- Phase
- Phase 2
- 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 55 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 55 years or older
- currently taking at least 2 anti-hypertensive medications
- systolic blood pressure between 140-159 mmHg
- diastolic blood pressure less than 90 mmHg
- read and understand English
- access to a telephone
- ability to attend all study visits
Who cannot join
- other cardiovascular disease
- major medical illness
- previous experience with any RR eliciting technique
- current use of:beta-agonist bronchodilators, systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than SSRIs), dicyclomine, bile acid binding resins, or sympathomimetic medication
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to determine whether the relaxation response is more effective than attention control in reducing blood pressure and medication dosage in elderly adults with isolated systolic hypertension.
Read the detailed description
The purpose of this study is to determine whether the relaxation response is more effective than health education training (attention control) in reducing systolic blood pressure and anti-hypertensive medication elimination in elderly adults with isolated systolic hypertension.
- Conditions
- Hypertension
- Being tested
- Relaxation response
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Relaxation responseBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine whether the relaxation response is more effective than a health education control in reducing blood pressure in elderly adults with isolated systolic hypertension.
Secondary outcomes (1)
Evaluate whether the relaxation response is more effective than a health education control to safely reduce blood pressure medications in elderly adults with isolated systolic hypertension..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2005 (estimated)
- Study startAug 2001
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 Beth Israel Deaconess Medical CenterThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 122 participants
Sponsor and investigators
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Investigators
- Herbert Benson, MD, Principal investigator, Beth Israel Deaconess Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00179543
- Sponsor's protocol ID
- 2001-P-001727
- Other IDs
- CDC grant: H75-CCH-123424, CDC grant: H75-CCH-119124, CDC grant: R01 DP00039
- Status last verified
- Sep 2006
- First submitted
- 13 Sep 2005
- Last updated
- 19 Sep 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanisms and Therapeutic Effects of the Relaxation Response in Elderly Hypertensive Patients
- ClinicalTrials.gov ID
- NCT00179543
- Acronym / sponsor ID
- 2001-P-001727
- Conditions
- Hypertension
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants
- Lead sponsor
- Beth Israel Deaconess Medical CenterUniversity, hospital or other
- Collaborators
- Centers for Disease Control and Prevention
- Study start
- Aug 2001
- First posted
- 16 Sep 2005 (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 determine whether the relaxation response is more effective than attention control in reducing blood pressure and medication dosage in elderly adults with isolated systolic hypertension.
Detailed description
The purpose of this study is to determine whether the relaxation response is more effective than health education training (attention control) in reducing systolic blood pressure and anti-hypertensive medication elimination in elderly adults with isolated systolic hypertension.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 55 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 55 years or older
- currently taking at least 2 anti-hypertensive medications
- systolic blood pressure between 140-159 mmHg
- diastolic blood pressure less than 90 mmHg
- read and understand English
Key exclusion criteria (4 listed)
- other cardiovascular disease
- major medical illness
- previous experience with any RR eliciting technique
- current use of:beta-agonist bronchodilators, systemic corticosteroids, anti-convulsants/psychotics, immunosuppressants, cytotoxic therapy, anabolic steroids, antidepressants (other than SSRIs), dicyclomine, bile acid binding resins, or sympathomimetic medication
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 |
|---|---|---|
| Relaxation response | Behavioural | – |
Primary outcome
Determine whether the relaxation response is more effective than a health education control in reducing blood pressure in elderly adults with isolated systolic hypertension.
1 secondary outcome
Evaluate whether the relaxation response is more effective than a health education control to safely reduce blood pressure medications in elderly adults with isolated systolic hypertension..
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 19 Sep 2006.
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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.
Herbert Benson, MD principal investigator
Beth Israel Deaconess Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Relaxation response in people with Hypertension, run by Beth Israel Deaconess Medical Center 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 7 inclusion and 4 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 19 Sep 2006. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Determine whether the relaxation response is more effective than a health education control in reducing blood pressure in elderly adults with isolated systolic hypertension.. 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 19 Sep 2006.