Effects of Age and Exercise on Blood Pressure Regulation

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2009 by National Institute on Aging (NIA).
Recruitment status was  Recruiting
Sponsor:
Information provided by:
National Institute on Aging (NIA)
ClinicalTrials.gov Identifier:
NCT00319397
First received: April 26, 2006
Last updated: December 10, 2009
Last verified: January 2009
  Purpose

The purpose of this study is to investigate the effects of age, exercise and cardiovascular disease on blood pressure.


Condition Intervention
Cardiovascular Disease
Aging
Behavioral: Exercise-Training Program

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Arterial Stiffness With Age: Part 1 and 2

Resource links provided by NLM:


Further study details as provided by National Institute on Aging (NIA):

Estimated Enrollment: 80
Study Start Date: April 2004
Estimated Study Completion Date: March 2007
Detailed Description:

This study is being done to find out how age, activity level, and the presence of heart disease affect the way the body controls blood pressure. A total of 80 individuals will be recruited for the study, and will consist of two groups: sedentary healthy individuals and those with coronary artery disease (CAD). Each group will undergo screening tests, including history, questionnaires, physical exam, lab tests, treadmill exercise tolerance test, and maximal exercise test. These screening tests will be repeated at 3 months and 6 months.

The study involves 20 visits over a 6-month period. An exercise-training program will be designed for the individual's fitness level. During the first month, the individual will be supervised while exercising at Spaulding Rehabilitation Hospital, but after that may choose to exercise at home or in a fitness center. These exercise sessions will take place 3-5 times per week for 15-40 minutes per session based on the individual's exercise program, increasing to 4-6 times per week for 30-60 minutes per session after the first month. Participants will be required to visit Spaulding Rehabilitation Hospital a minimum of once every two weeks so that information can be collected from a heart rate monitor.

Testing is done at the beginning and end of the exercise-training intervention period to determine what effect the intervention has had on the individual's blood pressure regulation. This testing consists of 2 sequential study days. During the first day's testing, which will last about 2 hours, the participant will receive 8 low doses of atropine to alter vagal effects. On the second day, which will take about 4 hours, the participant will receive sodium nitroprusside, phenylephrine, and low-dose atropine while sympathetic nervous activity is recorded. Differences in blood pressure regulation pre- and post-training will be studied.

  Eligibility

Ages Eligible for Study:   55 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

Sedentary Older Individuals Group:

  • Healthy men and women ages 55-75
  • Normally physically active (performing regular aerobic exercise less than 60 minutes per week) with aerobic capacities below the 80th percentile for age and gender

Coronary Artery Disease (CAD) Group:

  • Men and women ages 55-75
  • Written authorization from participant's cardiologist to participate in the study (Note: if Dr. Zervos is the participant's cardiologist, their primary care physician will also be asked to give written authorization)
  • Documented CAD by previous MI or angiography

Exclusion Criteria:

General exclusion criteria for all groups:

  • Neurological diseases
  • Diabetes
  • History of migraine headaches
  • Hypertension
  • Glaucoma
  • Pacemaker
  • History of stroke or TIA
  • High cholesterol
  • Current cancer
  • Benign prostatic hyperplasia
  • Allergy to sulfa
  • Carotid disease
  • Currently taking anti-depression, anti-psychotic, or anti-anxiety medications

Sedentary Older Individuals Group:

  • Coronary artery or carotid vascular disease

Coronary Artery Disease (CAD) Group:

  • Myocardial Infarction (MI), Percutaneous Transluminal Coronary Angioplasty (PTCA) or Coronary Artery Bypass Graft (CABG) in the last 3 months
  • Unstable angina, EF branch block severe valvular disease, chronic atrial fibrillation, and frequent atrial or ventricular arrhythmias (including more than 3 PVCs or APCs per minute)
  • Currently taking anticoagulants or any cardioactive medications other than ACE inhibitors, calcium channel blockers, and beta-blockers
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00319397

Contacts
Contact: Glen Picard, MA 617-573-2786 apicard@partners.org
Contact: J. Andrew Taylor, PhD 617-573-2784 jandrew_taylor@hms.harvard.edu

Locations
United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Glen Picard, MA    617-573-2786    gpicard@partners.org   
Contact: J. Andrew Taylor    617-573-2784    jandrew_taylor@hms.harvard.edu   
Principal Investigator: J. Andrew Taylor, PhD         
Sponsors and Collaborators
Investigators
Principal Investigator: J. Andrew Taylor, PhD Spaulding Rehabilitation Hospital, Harvard Medical School
Principal Investigator: Gerasimos Zervos, MD Chief of Nuclear Cardiology, Massachusetts General Hospital
  More Information

Publications:
Responsible Party: J. Andrew Taylor, PhD, Spaulding Rehabilitation Hospital
ClinicalTrials.gov Identifier: NCT00319397     History of Changes
Other Study ID Numbers: AG0063, RO1AG14376
Study First Received: April 26, 2006
Last Updated: December 10, 2009
Health Authority: United States: Federal Government

Keywords provided by National Institute on Aging (NIA):
vascular resistance
vasomotion
coronary disorder
hemodynamics
physical fitness

Additional relevant MeSH terms:
Cardiovascular Diseases

ClinicalTrials.gov processed this record on July 10, 2014