Cardiovascular DiseaseNCT00319397
Effects of Age and Exercise on Blood Pressure Regulation
An observational study of Cardiovascular Disease and Aging, run by National Institute on Aging (NIA) at 1 site in United States.
Trial summary
The purpose of this study is to investigate the effects of age, exercise and cardiovascular disease on blood pressure. Read more about this study
- Who is it for?
- Ages 55 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Disease, Aging
- What is being tested?
- Exercise-Training Program
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2004to Mar 2007
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- General exclusion criteria for all groups:
- Neurological diseases
- Diabetes
- History of migraine headaches
- Hypertension
- Glaucoma
Show all 20Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Spaulding Rehabilitation Hospital
Boston, Massachusetts, 02114
Glen Picard, MA, 617-573-2786, gpicard@partners.org
J. Andrew Taylor, 617-573-2784, jandrew_taylor@hms.harvard.edu
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Disease, Aging
- Being tested
- Exercise-Training Program
- Keywords
- vascular resistance, vasomotion, coronary disorder, hemodynamics, physical fitness
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise-Training ProgramBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2006 (estimated)
- Study startApr 2004
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute on Aging (NIA)
- Sponsor type
- US National Institutes of Health
- Investigators
- J. Andrew Taylor, PhD, Principal investigator, Spaulding Rehabilitation Hospital, Harvard Medical SchoolGerasimos Zervos, MD, Principal investigator, Chief of Nuclear Cardiology, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00319397
- Sponsor's protocol ID
- AG0063
- Other IDs
- R01AG014376
- Status last verified
- Jan 2009
- First submitted
- 26 Apr 2006
- Last updated
- 14 Dec 2009
- Results posted
- No
Publications
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.
PubMed 4235387Wallin 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.
PubMed 3288106Eckberg 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.
PubMed 2690582Yuasa 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.
PubMed 10821129Ikuta 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.
PubMed 7782571Alcalay 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.
PubMed 1424426Smyth 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.
PubMed 4303309
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Arterial Stiffness With Age: Part 1 and 2
- ClinicalTrials.gov ID
- NCT00319397
- Acronym / sponsor ID
- AG0063
- Conditions
- Cardiovascular Disease, Aging
- Keywords
- vascular resistance, vasomotion, coronary disorder, hemodynamics, physical fitness
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- National Institute on Aging (NIA)US National Institutes of Health
- Study start
- Apr 2004
- Study completion
- Mar 2007
- First posted
- 27 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Time perspective
- Prospective
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
- 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
Key exclusion criteria (20 listed)
- Neurological diseases
- Diabetes
- History of migraine headaches
- Hypertension
- Glaucoma
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise-Training Program | Behavioural | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2009.
- Background: PubMed 4235387Hagbarth 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.
- Background: PubMed 3288106Wallin 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.
- Background: PubMed 2690582Eckberg 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.
- Background: PubMed 10821129Yuasa 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.
- Background: PubMed 7782571Ikuta 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.
- Background: PubMed 1424426Alcalay 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.
- Background: PubMed 4303309Smyth 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
J. Andrew Taylor, PhD principal investigator
Spaulding Rehabilitation Hospital, Harvard Medical School
Gerasimos Zervos, MD principal investigator
Chief of Nuclear Cardiology, Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Disease and Aging, run by National Institute on Aging (NIA) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Glen Picard, MA (617-573-2786, apicard@partners.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00319397, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2009.