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Relaxation Response Training to Treat Hypertension

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ClinicalTrials.gov Identifier: NCT01263743
Recruitment Status : Completed
First Posted : December 21, 2010
Last Update Posted : April 19, 2016
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital

Brief Summary:
Interventions such as Relaxation Response appear to have widespread effects on physiology. Endothelial function, changes in genomic expression, several biomarkers have been associated with chronic stress and cardiovascular dysfunction, and there is some suggestion that elicitation of the Relaxation Response may lead to improvement in-or normalization of-these factors. By studying the impact of the Relaxation Response on endothelial function, genomic expression and biomarkers among subjects with hypertension, it may be possible to better understand the biologic underpinnings of Relaxation Response-type interventions. Furthermore, with a greater understanding of the physiologic mechanisms by which the Relaxation Response works, it may be possible to better target other symptoms and conditions that can be effectively treated by such an intervention.

Condition or disease Intervention/treatment
Hypertension Behavioral: Relaxation Response

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Relaxation Response Training to Treat Hypertension: Effects on Blood Pressure, Biomarkers, and Endothelial Function
Study Start Date : April 2009
Primary Completion Date : June 2011
Study Completion Date : June 2011

Arm Intervention/treatment
Experimental: This is a single arm study
Relaxation Response training will be given to all participants
Behavioral: Relaxation Response
The Relaxation Response is a type of relaxation. The goal of the Relaxation Response is to consciously elicit a reaction opposite in direction to the stress response.
Other Name: Meditation
Behavioral: Relaxation Response
Relaxation Response is a type of relaxation. This is a technique that elicits a state that is opposite to the stress response.
Other Name: Meditation



Primary Outcome Measures :
  1. Endothelial Function [ Time Frame: Eight weeks of Relaxation Response Training ]

Secondary Outcome Measures :
  1. Blood Pressure [ Time Frame: Eight Weeks of Relaxation Response Training ]
  2. Genomic Expression [ Time Frame: Eight Weeks of Relaxation Response Training ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

General Inclusion Criteria:

  • Healthy men and women
  • Hypertension (stage 1)
  • 18-70 years old

General Exclusion Criteria

  • No asthma or nasal allergies
  • Non-smokers
  • If on anti-hypertensive medication willing to discontinue
  • Cannot currently practice Tai Chi, meditation, or yoga regularly
  • Current use of the following medications: phosphodiesterase type 5 inhibitors, long-acting nitrates, systemic corticosteroids, anti-inflammatories, immunosuppressive or cytotoxic therapies (currently or within the last 12 months), anabolic steroids, and antidepressants.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01263743


Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Brigham and Women's Hospital
Investigators
Principal Investigator: Jeffrey Huffman, MD Massachusetts General Hospital
Study Director: Randall Zusman, MD Massachusetts General Hospital
Study Director: Mark A Creager, MD Brigham and Women's Hospital
Study Director: John W Denninger, MD Massachusetts General Hospital
Study Director: Herbert Benson, MD Massachusetts General Hospital
Study Director: Gregory Fricchione, MD Massachusetts General Hospital

Responsible Party: Jeff C. Huffman, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01263743     History of Changes
Other Study ID Numbers: 2008P002244
First Posted: December 21, 2010    Key Record Dates
Last Update Posted: April 19, 2016
Last Verified: April 2016

Keywords provided by Jeff C. Huffman, MD, Massachusetts General Hospital:
Stage 1 hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases