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, 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.

Study Overview

• Status: Completed
• Conditions: Hypertension
• Intervention / Treatment: Behavioral: Relaxation Response; Behavioral: Relaxation Response

• Study Type: Interventional
• Enrollment (Actual): 58
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: 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 Names: Meditation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Endothelial Function	Eight weeks of Relaxation Response Training

Secondary Outcome Measures

Outcome Measure	Time Frame
Blood Pressure	Eight Weeks of Relaxation Response Training
Genomic Expression	Eight Weeks of Relaxation Response Training

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Brigham and Women's Hospital
• Investigators: Study Director: Herbert Benson, MD, Massachusetts General Hospital; Study Director: Gregory Fricchione, MD, Massachusetts General 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 record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): June 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: December 14, 2010
• First Submitted That Met QC Criteria: December 20, 2010
• First Posted (Estimate): December 21, 2010

Study Record Updates

• Last Update Posted (Estimate): April 19, 2016
• Last Update Submitted That Met QC Criteria: April 18, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Keywords: Stage 1 hypertension
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 2008P002244