Effects of Age and Exercise on Blood Pressure Regulation
NCT ID: NCT00319397
Last Updated: 2009-12-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
80 participants
OBSERVATIONAL
2004-04-30
2007-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
PROSPECTIVE
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exercise-Training Program
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
55 Years
75 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Institute on Aging (NIA)
NIH
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Spaulding Rehabilitation Hospital
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
J. Andrew Taylor, PhD
Role: PRINCIPAL_INVESTIGATOR
Spaulding Rehabilitation Hospital, Harvard Medical School
Gerasimos Zervos, MD
Role: PRINCIPAL_INVESTIGATOR
Chief of Nuclear Cardiology, Massachusetts General Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Spaulding Rehabilitation Hospital
Boston, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Glen Picard, MA
Role: primary
J. Andrew Taylor
Role: backup
References
Explore related publications, articles, or registry entries linked to this study.
Hagbarth KE, Vallbo AB. Pulse and respiratory grouping of sympathetic impulses in human muscle-nerves. Acta Physiol Scand. 1968 Sep-Oct;74(1):96-108. doi: 10.1111/j.1748-1716.1968.tb04218.x. No abstract available.
Wallin BG, Fagius J. Peripheral sympathetic neural activity in conscious humans. Annu Rev Physiol. 1988;50:565-76. doi: 10.1146/annurev.ph.50.030188.003025. No abstract available.
Eckberg DL, Wallin BG, Fagius J, Lundberg L, Torebjork HE. Prospective study of symptoms after human microneurography. Acta Physiol Scand. 1989 Dec;137(4):567-9. doi: 10.1111/j.1748-1716.1989.tb08804.x. No abstract available.
Yuasa T, Takata S, Maruyama M, Yasuma K, Yoshizawa H, Kontani M, Nagai H, Sakagami S, Kobayashi K. Low-dose atropine attenuates muscle sympathetic nerve activity in healthy humans. Hypertens Res. 2000 May;23(3):213-8. doi: 10.1291/hypres.23.213.
Ikuta Y, Shimoda O, Kano T. Quantitative assessment of the autonomic nervous system activities during atropine-induced bradycardia by heart rate spectral analysis. J Auton Nerv Syst. 1995 Mar 18;52(1):71-6. doi: 10.1016/0165-1838(94)00148-d.
Alcalay M, Izraeli S, Wallach-Kapon R, Tochner Z, Benjamini Y, Akselrod S. Paradoxical pharmacodynamic effect of atropine on parasympathetic control: a study by spectral analysis of heart rate fluctuations. Clin Pharmacol Ther. 1992 Nov;52(5):518-27. doi: 10.1038/clpt.1992.180.
Smyth HS, Sleight P, Pickering GW. Reflex regulation of arterial pressure during sleep in man. A quantitative method of assessing baroreflex sensitivity. Circ Res. 1969 Jan;24(1):109-21. doi: 10.1161/01.res.24.1.109. No abstract available.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AG0063
Identifier Type: -
Identifier Source: org_study_id