Effects of Age and Exercise on Blood Pressure Regulation

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. Identifier: NCT00319397
Recruitment Status : Unknown
Verified January 2009 by National Institute on Aging (NIA).
Recruitment status was:  Recruiting
First Posted : April 27, 2006
Last Update Posted : December 14, 2009
Information provided by:
National Institute on Aging (NIA)

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

Condition or disease Intervention/treatment
Cardiovascular Disease Aging Behavioral: Exercise-Training Program

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.

Study Type : Observational
Estimated Enrollment : 80 participants
Time Perspective: Prospective
Official Title: Arterial Stiffness With Age: Part 1 and 2
Study Start Date : April 2004
Study Completion Date : March 2007

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Ages Eligible for Study:   55 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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

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 identifier (NCT number): NCT00319397

Contact: Glen Picard, MA 617-573-2786
Contact: J. Andrew Taylor, PhD 617-573-2784

United States, Massachusetts
Spaulding Rehabilitation Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Glen Picard, MA    617-573-2786   
Contact: J. Andrew Taylor    617-573-2784   
Principal Investigator: J. Andrew Taylor, PhD         
Sponsors and Collaborators
National Institute on Aging (NIA)
Principal Investigator: J. Andrew Taylor, PhD Spaulding Rehabilitation Hospital, Harvard Medical School
Principal Investigator: Gerasimos Zervos, MD Chief of Nuclear Cardiology, Massachusetts General Hospital

Responsible Party: J. Andrew Taylor, PhD, Spaulding Rehabilitation Hospital Identifier: NCT00319397     History of Changes
Other Study ID Numbers: AG0063
R01AG014376 ( U.S. NIH Grant/Contract )
First Posted: April 27, 2006    Key Record Dates
Last Update Posted: December 14, 2009
Last Verified: January 2009

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

Additional relevant MeSH terms:
Cardiovascular Diseases