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Effects of Age and Exercise on Blood Pressure Regulation

This study is currently recruiting participants.
Information provided by National Institute on Aging (NIA)

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Descriptive Information Fields
Brief Title  Effects of Age and Exercise on Blood Pressure Regulation
Official Title  Arterial Stiffness With Age: Part 1 and 2
Brief Summary

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

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 Phase Phase IV
Study Type  Observational
Study Design  Screening, Cross-Sectional, Defined Population, Prospective Study
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Cardiovascular Disease
Aging
Intervention  Behavioral: Exercise-Training Program
MEDLINE PMIDs 4235387,   3288106,   2690582,   10821129,   7782571,   1424426,   4303309
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  80
Start Date  April 2004
Completion Date March 2007
Eligibility 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
Gender Both
Ages 55 Years to 75 Years
Accepts Healthy Volunteers Yes
Contacts ††
Contact: Glen Picard, MA     617-573-2786     apicard@partners.org    
Contact: Claudia Bartolini, BA     617-573-2783     cbartolini@partners.org    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00319397
Organization ID AG0063
Secondary IDs †† RO1AG14376
Study Sponsor  National Institute on Aging (NIA)
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    
Information Provided By National Institute on Aging (NIA)
Verification Date September 2007
First Received Date  April 26, 2006
Last Updated Date September 19, 2007

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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