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| Tracking Information | |||||||||
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| First Received Date ICMJE | April 26, 2006 | ||||||||
| Last Updated Date | January 29, 2009 | ||||||||
| Start Date ICMJE | April 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00319397 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Effects of Age and Exercise on Blood Pressure Regulation | ||||||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: Exercise-Training Program | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 80 | ||||||||
| Completion Date | March 2007 | ||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Sedentary Older Individuals Group:
Coronary Artery Disease (CAD) Group:
Exclusion Criteria: General exclusion criteria for all groups:
Sedentary Older Individuals Group:
Coronary Artery Disease (CAD) Group:
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| Gender | Both | ||||||||
| Ages | 55 Years to 75 Years | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00319397 | ||||||||
| Responsible Party | J. Andrew Taylor, PhD, Spaulding Rehabilitation Hospital | ||||||||
| Study ID Numbers ICMJE | AG0063, RO1AG14376 | ||||||||
| Study Sponsor ICMJE | National Institute on Aging (NIA) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Institute on Aging (NIA) | ||||||||
| Verification Date | January 2009 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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