Relaxation Response Training to Treat Hypertension

NCT01263743 | Completed

• 1 other identifier: 2008P002244
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension

Keywords

Stage 1 hypertension

Outcome Measures

Primary Outcomes (1)

• Endothelial Function

  Eight weeks of Relaxation Response Training

Secondary Outcomes (2)

• Blood Pressure

  Eight Weeks of Relaxation Response Training

• Genomic Expression

  Eight Weeks of Relaxation Response Training

Study Arms (1)

This is a single arm study

EXPERIMENTAL

Relaxation Response training will be given to all participants

Behavioral: Relaxation Response

Interventions

Relaxation Response BEHAVIORAL

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.

Also known as: Meditation

This is a single arm study

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Brigham and Women's Hospital: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Hypertension

Interventions

Meditation

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Spiritual Therapies; Relaxation Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jeffrey Huffman, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

• 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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 14, 2010
• First Posted: December 21, 2010
• Study Start: April 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: April 19, 2016

Record last verified: 2016-04

Locations

US (1)