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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

April 26, 2006
December 10, 2009
April 2004
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Complete list of historical versions of study NCT00319397 on ClinicalTrials.gov Archive Site
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Effects of Age and Exercise on Blood Pressure Regulation
Arterial Stiffness With Age: Part 1 and 2

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

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.

Observational
Time Perspective: Prospective
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  • Cardiovascular Disease
  • Aging
Behavioral: Exercise-Training Program
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
March 2007
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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
Both
55 Years to 75 Years
Yes
Contact: Glen Picard, MA 617-573-2786 apicard@partners.org
Contact: J. Andrew Taylor, PhD 617-573-2784 jandrew_taylor@hms.harvard.edu
United States
 
NCT00319397
AG0063, RO1AG14376
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J. Andrew Taylor, PhD, Spaulding Rehabilitation Hospital
National Institute on Aging (NIA)
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Principal Investigator: J. Andrew Taylor, PhD Spaulding Rehabilitation Hospital, Harvard Medical School
Principal Investigator: Gerasimos Zervos, MD Chief of Nuclear Cardiology, Massachusetts General Hospital
National Institute on Aging (NIA)
January 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP