ClinicalTrials.gov
ClinicalTrials.gov Menu

The Effect of a Complementary Multi Disciplinary Program on Blood Pressure in Hypertensive Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00409149
Recruitment Status : Completed
First Posted : December 8, 2006
Last Update Posted : January 19, 2011
Sponsor:
Information provided by:
Assaf-Harofeh Medical Center

Brief Summary:

Intervention description:

Complementary Approaches to Lower Mean arterial pressure (CALM) is a multi dispensary program aimed to reduce blood pressure in hypertensive patients. The program utilizes a naturopathic dietary approach, education on cooking and food consumption choices, walking physical exercise, Qi Gong - a form of Chinese slow movement exercise combined with relaxation breathing and imagery and group therapy coaching in stress management techniques and mind-body balancing techniques.

Trial Objectives:

To compare the effect of CALM in reducing blood pressure to the standard dietary DASH approach in hypertensive patients.

Methodology:

120 Participants will be randomly assigned in to two groups:

  • CALM program for reducing blood pressure as the treatment group.
  • Standard DASH diet and lifestyle modification counseling as the control group. Inclusion Criteria
  • Adult men and women over 18 years.
  • Patients using anti hypertensive medications with mean systolic blood pressure measurements of 120-180 mm Hg and/or mean diastolic measurements of 70-100 mm Hg as determined by a 24 hour Holter test.
  • Patients not using anti hypertensive medications with mean systolic blood pressure measurements of 130-180 mm Hg and or mean diastolic measurements of 80-100 mmHg.
  • Signed informed consent (appears in IRB forms)

Assessment of Efficacy Primary end point efficacy will be assessed by comparing the mean BP measurements in the CALM group to the mean BP measurements in the DASH control group. Blood pressure measurements will be performed by 24 hours Holter BP monitoring in the beginning and at the end of the trial.

Secondary end points efficacy will be assed by comparing CALM to DASH programs with respect to effects use of BP medications and weight loss. Lab test and pulse wave analysis will also be assessed at the beginning and at the end of the study.


Condition or disease Intervention/treatment Phase
Hypertension Behavioral: CALM Approache Behavioral: DASH approach Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 113 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Comprehensive Approach to Lower Measured Blood Pressure (CALM-BP) - Results From a Randomized Controlled Trial
Study Start Date : December 2006
Actual Primary Completion Date : October 2008
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: CALM BP
dietary approach, education on cooking and food consumption choices, walking physical exercise, Qi Gong - a form of Chinese slow movement exercise combined with relaxation breathing and imagery and group therapy coaching in stress management techniques and mind-body balancing techniques.
Behavioral: CALM Approache
Active Comparator: DASH
standard dietary DASH approach in hypertensive patients
Behavioral: DASH approach
standard dietary DASH approach in hypertensive patients



Primary Outcome Measures :
  1. Change in blood pressure


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult men and women over 18 years.
  • Patients using anti hypertensive medications with mean systolic blood pressure measurements of 120-180 mm Hg and/or mean diastolic measurements of 70-100 mm Hg as determined by a 24 hour Holter test.
  • Patients not using anti hypertensive medications with mean systolic blood pressure measurements of 130-180 mm Hg and or mean diastolic measurements of 80-100 mmHg.
  • Signed informed consent

Exclusion Criteria:

  • Cardiovascular event within the past 6 months
  • Inability to walk independently for 15 or less minutes.
  • Poorly controlled insulin dependant diabetes mellitus with Hg A1c measurements over 7.5.
  • Inflammatory bowl disorders
  • Acute malignancy with life expectancy of less than 5 years.
  • Pregnancy or lactation
  • A body mass index of more than 35.
  • More than 20 alcoholic beverages per weak.
  • Change in anti hypertensive medications within the last 3 months.
  • Planning to change smoking habits

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00409149


Locations
Israel
Research & Development Unit, Assaf-Harofeh Medical Center,
Zerifin, Israel, 70300
Sponsors and Collaborators
Assaf-Harofeh Medical Center
Investigators
Principal Investigator: Shai Efrati, MD Assaf-Harofeh Medical Center
Study Chair: Amos Ziv, M.Sc. Assaf-Harofeh Medical Center

ClinicalTrials.gov Identifier: NCT00409149     History of Changes
Other Study ID Numbers: 140/06
First Posted: December 8, 2006    Key Record Dates
Last Update Posted: January 19, 2011
Last Verified: April 2007

Keywords provided by Assaf-Harofeh Medical Center:
Hypertension
Diet
physical exercise
naturopathic
group therapy
Qi Gong

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases