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Relaxation Response Training to Treat Hypertension

This study has been completed.
Sponsor:
Collaborator:
Brigham and Women's Hospital
Information provided by (Responsible Party):
Jeff C. Huffman, MD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT01263743
First received: December 14, 2010
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

Interventions such as Relaxation Response appear to have widespread effects on physiology. Endothelial function and 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 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 Intervention
Hypertension
 Behavioral: Relaxation Response

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: Relaxation Response Training to Treat Hypertension: Effects on Blood Pressure, Biomarkers, and Endothelial Function

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Endothelial Function [ Time Frame: Eight weeks of Relaxation Response Training ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Blood Pressure [ Time Frame: Eight Weeks of Relaxation Response Training ] [ Designated as safety issue: Yes ]

Enrollment: 58
Study Start Date: April 2009
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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: phospodiesterase 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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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 Ficchione, MD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Jeff C. Huffman, MD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT01263743     History of Changes
Other Study ID Numbers: 2008P002244
Study First Received: December 14, 2010
Last Updated: April 26, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Massachusetts General Hospital:
Stage 1 hypertension

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 23, 2013