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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

December 14, 2010
April 26, 2012
April 2009
June 2011   (final data collection date for primary outcome measure)
Endothelial Function [ Time Frame: Eight weeks of Relaxation Response Training ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01263743 on ClinicalTrials.gov Archive Site
Blood Pressure [ Time Frame: Eight Weeks of Relaxation Response Training ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Relaxation Response Training to Treat Hypertension
Relaxation Response Training to Treat Hypertension: Effects on Blood Pressure, Biomarkers, and Endothelial Function

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.
Not Provided
Interventional
Not Provided
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Supportive Care
Hypertension
  • 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
Experimental: This is a single arm study
Relaxation Response training will be given to all participants
Interventions:
  • Behavioral: Relaxation Response
  • Behavioral: Relaxation Response
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
58
June 2011
June 2011   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01263743
2008P002244
No
Jeff C. Huffman, MD, Massachusetts General Hospital
Massachusetts General Hospital
Brigham and Women's Hospital
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
Massachusetts General Hospital
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP