Relaxation Response Training to Treat Hypertension

NCT ID: NCT01263743

Last Updated: 2016-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2011-06-30

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

This is a single arm study

Relaxation Response training will be given to all participants

Group Type: EXPERIMENTAL

Relaxation Response

Intervention Type: 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.

Relaxation Response

Intervention Type: BEHAVIORAL

Relaxation Response is a type of relaxation. This is a technique that elicits a state that is opposite to the stress response.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Meditation; Meditation

Eligibility Criteria

Inclusion Criteria

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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Brigham and Women's Hospital

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jeff C. Huffman, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jeffrey Huffman, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Randall Zusman, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Mark A Creager, MD

Role: STUDY_DIRECTOR

Brigham and Women's Hospital

John W Denninger, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Herbert Benson, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Gregory Fricchione, MD

Role: STUDY_DIRECTOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2008P002244

Identifier Type: -

Identifier Source: org_study_id