Vascular FormationPhase 2NCT00246883
Effect of Regular Exercise on Vascular Function and Cardiovascular Risk in a Sedentary Work Force
A Phase 2 study testing Exercise in people with Vascular Formation, run by National Heart, Lung, and Blood Institute (NHLBI) at 1 site in United States.
Trial summary
This study will evaluate the effects of NHLBI's employee exercise program, Keep the Beat, on blood vessel function. Damage to blood vessels can cause narrowing of the vessels, resulting in reduced blood flow to parts of the body such as the heart. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Vascular Formation
- What is being tested?
- Exercise
- Type of treatment
- Surgery or procedure
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Oct 2005to 15 Apr 2009
- Phase
- Phase 2
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Employees of NHLBI who are not currently participating in the Keep the Beat program (this may include employees who have previously registered for Keep the Beat program, but who have not participated in the past 3 months) and NIH employees who can use the excercise rooms in Building 10, Building 31, or Rockledge II.
- No medical condition that might prohibit safe participation in the Keep the Beat program.
- Subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations.
Who cannot join
- Heart disease as indicated by history of myocardial infarction, documented disease on coronary angiography, coronary artery stent placement, congestive heart failure, significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, or valvular heart disease), or positive treadmill exercise test at baseline.
- Baseline blood pressure systolic greater than 140 mmHg or diastolic greater than 90 mmHg on 2 measures with or without hypertensive medications. Subjects will be encouraged to seek evaluation by their primary care provider.
- Baseline fasting blood glucose greater than 126 mg/dl, if subject previously undiagnosed as being diabetic. Subjects will be encouraged to seek evaluation by their primary care provider.
- Baseline fasting LDL greater than 190 mg/dl. Subjects will be encouraged to seek evaluation by their primary care provider.
- Physically unable to perform the Keep the Beat program due to neurologic or orthopedic conditions.
- Pregnant women will be excluded due to large hormonal changes in pregnancy that affect study variables and potential pregnancy-related restrictions on exercise.
- Subjects currently exercising more than 1.5 hours per week including brisk walking, sporting activities (such as basketball), and other deliberate exercise.
- Subjects may not be currently participating or participate over the course of the study in another study protocol which includes blood draws or interventions.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, 20892
About this study
Official title: Effect of Regular Exercise on Vascular Function and Cardiovascular Risk in a Sedentary Work Force: The NHLBI "Keep the Beat" Program
This study will evaluate the effects of NHLBI's employee exercise program, Keep the Beat, on blood vessel function. Damage to blood vessels can cause narrowing of the vessels, resulting in reduced blood flow to parts of the body such as the heart. Stem cells called endothelial progenitor cells, or EPCs, may be able to heal blood vessel damage. Exercise, such as walking on a treadmill, can help move EPCs from the bone marrow where they originate into the blood stream to help heal the damaged blood vessels. The Keep the Beat program encourages NHLBI employees to exercise 15 minutes during the workday and provides exercise facilities to accomplish this.
NHLBI employees who have access to NIH exercise facilities may be eligible for this study. Candidates must have no history of heart disease, must not currently be exercising more than 1.5 hours per week and must not have participated in the Keep the Beat program for 3 months prior to entering the study. They are screened with blood tests and blood pressure measurements.
Read more
Participants undergo the following tests and procedures before beginning the study and 3 months after participating in Keep the Beat:
- Blood tests to identify EPCs and their function, measure the level of nitric oxide (a gas produced by healthy blood vessels), and measure C-reactive protein (an inflammatory marker that may be a risk factor for cardiovascular disease).
- Brachial artery reactivity study to measure how well the arteries widen. An ultrasound device is placed over the subject's artery just above the elbow. The device measures the size of the artery and the flow of blood through it before and after a pressure cuff is inflated around the forearm.
- Treadmill exercise testing to evaluate physical fitness. Subjects exercise on a treadmill for as long as they can. An exercise specialist is present throughout the test. Heart rhythm and oxygen saturation are monitored continuously and blood pressure is measured every 3 minutes.
Read the detailed description
Evidence suggests that Americans are becoming increasingly sedentary at work and at home due to technological advances. Physical inactivity coupled with excess caloric intake, especially of calorie-rich fast foods, are responsible for the epidemic of obesity in this country. Physical inactivity in obese and non-obese individuals increases the risk of cardiovascular disease and all-cause mortality. Premature cardiovascular disease leads to lost productivity in the work place, impaired quality of life, and escalating health care costs. In response to these concerns, the American Heart Association advocates 30 minutes of aerobic exercise most days; however, busy schedules coupled with a lack of convenient access to exercise equipment (or motivation to use it) limit adoption of regular exercise by many. One year ago, the National Heart, Lung, and Blood Institute (NHLBI) initiated the Keep the Beat program which encourages Institute employees to engage in fifteen minutes of exercise during the work day, and provides exercise equipment at specific work sites to accomplish this goal. Yet, fewer than 10% of NHLBI employees regularly participate in Keep the Beat and many who initially enrolled have failed to continue participation. The purpose of our prospective cohort study is to determine whether participation in the Keep the Beat program can improve an important measure of cardiovascular risk-arterial endothelial function-by stimulating bone marrow-derived endothelial progenitor cells to repair endothelium. We propose to characterize important components of vascular health by measuring endothelial nitric oxide bioactivity, as determined by brachial artery reactivity to shear stress and nitric oxide metabolites in blood, and vascular repair potential, as determined by endothelial progenitor cell number and function, at baseline and at 3 months in National Institutes of Health employees who agree to participate in Keep the Beat. Secondary analyses will include other biomarkers of risk, such as C-reactive protein, blood pressure, body mass index, lipid profile, fasting glucose/insulin, and homeostasis model assessment index, to be measured in our study and subgroup analyses of participants at particularly high cardiovascular risk (greater than 20% over 10 years), minorities, and women. Demonstration of improved vascular function, with implications of reduced cardiovascular risk, may serve as an incentive for greater employee participation in established employer-initiated programs, and for adoption of similar programs by other employers. If objective benefit cannot be demonstrated in vascular function and other biomarkers of risk, modification of the program may be required to reduce cardiovascular risk.
- Conditions
- Vascular Formation
- Being tested
- Exercise
- Keywords
- Endothelial Progenitor Cells, Nitric Oxide, Brachial Artery Reactivity, Physical Fitness, C-reactive Protein, Exercise, Vascular Function
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement in brachial artery dilator responsiveness to shear stress as a bioassay for endothelium-dependent nitric oxide bioavailability following 3 months participation in the Keep the Beat program as compared with baseline measuraements.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study start26 Oct 2005
- Study completion15 Apr 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Vascular FormationStudies of the same condition, open and under way.
- More trials run by National Heart, Lung, and Blood Institute (NHLBI)The sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Enrolment
- 120 participants
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246883
- Sponsor's protocol ID
- 060018
- Other IDs
- 06-H-0018
- Status last verified
- 15 Apr 2009
- First submitted
- 29 Oct 2005
- Last updated
- 2 Jul 2017
- Results posted
- No
Publications
Blair SN, Kohl HW, Gordon NF, Paffenbarger RS Jr. How much physical activity is good for health? Annu Rev Public Health. 1992;13:99-126. doi: 10.1146/annurev.pu.13.050192.000531.
PubMed 1599603Hu G, Tuomilehto J, Silventoinen K, Barengo NC, Peltonen M, Jousilahti P. The effects of physical activity and body mass index on cardiovascular, cancer and all-cause mortality among 47 212 middle-aged Finnish men and women. Int J Obes (Lond). 2005 Aug;29(8):894-902. doi: 10.1038/sj.ijo.0802870.
PubMed 15724141Brownson RC, Boehmer TK, Luke DA. Declining rates of physical activity in the United States: what are the contributors? Annu Rev Public Health. 2005;26:421-43. doi: 10.1146/annurev.publhealth.26.021304.144437.
PubMed 15760296
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Regular Exercise on Vascular Function and Cardiovascular Risk in a Sedentary Work Force: The NHLBI "Keep the Beat" Program
- ClinicalTrials.gov ID
- NCT00246883
- Acronym / sponsor ID
- 060018
- Conditions
- Vascular Formation
- Keywords
- Endothelial Progenitor Cells, Nitric Oxide, Brachial Artery Reactivity, Physical Fitness, C-reactive Protein, Exercise, Vascular Function
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants
- Lead sponsor
- National Heart, Lung, and Blood Institute (NHLBI)US National Institutes of Health
- Study start
- 26 Oct 2005
- Study completion
- 15 Apr 2009
- First posted
- 31 Oct 2005 (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.
This study will evaluate the effects of NHLBI's employee exercise program, Keep the Beat, on blood vessel function. Damage to blood vessels can cause narrowing of the vessels, resulting in reduced blood flow to parts of the body such as the heart. Stem cells called endothelial progenitor cells, or EPCs, may be able to heal blood vessel damage. Exercise, such as walking on a treadmill, can help move EPCs from the bone marrow where they originate into the blood stream to help heal the damaged blood vessels. The Keep the Beat program encourages NHLBI employees to exercise 15 minutes during the workday and provides exercise facilities to accomplish this.
NHLBI employees who have access to NIH exercise facilities may be eligible for this study. Candidates must have no history of heart disease, must not currently be exercising more than 1.5 hours per week and must not have participated in the Keep the Beat program for 3 months prior to entering the study. They are screened with blood tests and blood pressure measurements.
Participants undergo the following tests and procedures before beginning the study and 3 months after participating in Keep the Beat:
- Blood tests to identify EPCs and their function, measure the level of nitric oxide (a gas produced by healthy blood vessels), and measure C-reactive protein (an inflammatory marker that may be a risk factor for cardiovascular disease).
- Brachial artery reactivity study to measure how well the arteries widen. An ultrasound device is placed over the subject's artery just above the elbow. The device measures the size of the artery and the flow of blood through it before and after a pressure cuff is inflated around the forearm.
- Treadmill exercise testing to evaluate physical fitness. Subjects exercise on a treadmill for as long as they can. An exercise specialist is present throughout the test. Heart rhythm and oxygen saturation are monitored continuously and blood pressure is measured every 3 minutes.
Detailed description
Evidence suggests that Americans are becoming increasingly sedentary at work and at home due to technological advances. Physical inactivity coupled with excess caloric intake, especially of calorie-rich fast foods, are responsible for the epidemic of obesity in this country. Physical inactivity in obese and non-obese individuals increases the risk of cardiovascular disease and all-cause mortality. Premature cardiovascular disease leads to lost productivity in the work place, impaired quality of life, and escalating health care costs. In response to these concerns, the American Heart Association advocates 30 minutes of aerobic exercise most days; however, busy schedules coupled with a lack of convenient access to exercise equipment (or motivation to use it) limit adoption of regular exercise by many. One year ago, the National Heart, Lung, and Blood Institute (NHLBI) initiated the Keep the Beat program which encourages Institute employees to engage in fifteen minutes of exercise during the work day, and provides exercise equipment at specific work sites to accomplish this goal. Yet, fewer than 10% of NHLBI employees regularly participate in Keep the Beat and many who initially enrolled have failed to continue participation. The purpose of our prospective cohort study is to determine whether participation in the Keep the Beat program can improve an important measure of cardiovascular risk-arterial endothelial function-by stimulating bone marrow-derived endothelial progenitor cells to repair endothelium. We propose to characterize important components of vascular health by measuring endothelial nitric oxide bioactivity, as determined by brachial artery reactivity to shear stress and nitric oxide metabolites in blood, and vascular repair potential, as determined by endothelial progenitor cell number and function, at baseline and at 3 months in National Institutes of Health employees who agree to participate in Keep the Beat. Secondary analyses will include other biomarkers of risk, such as C-reactive protein, blood pressure, body mass index, lipid profile, fasting glucose/insulin, and homeostasis model assessment index, to be measured in our study and subgroup analyses of participants at particularly high cardiovascular risk (greater than 20% over 10 years), minorities, and women. Demonstration of improved vascular function, with implications of reduced cardiovascular risk, may serve as an incentive for greater employee participation in established employer-initiated programs, and for adoption of similar programs by other employers. If objective benefit cannot be demonstrated in vascular function and other biomarkers of risk, modification of the program may be required to reduce cardiovascular risk.
Study design
- Primary purpose
- Treatment
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Employees of NHLBI who are not currently participating in the Keep the Beat program (this may include employees who have previously registered for Keep the Beat program, but who have not participated in the past 3 months) and NIH employees who can use the excercise rooms in Building 10, Building 31, or Rockledge II.
- No medical condition that might prohibit safe participation in the Keep the Beat program.
- Subject understands protocol and provides written, informed consent in addition to willingness to comply with specified follow-up evaluations.
Key exclusion criteria (8 listed)
- Heart disease as indicated by history of myocardial infarction, documented disease on coronary angiography, coronary artery stent placement, congestive heart failure, significant structural heart disease (e.g. hypertrophic or dilated cardiomyopathy, or valvular heart disease), or positive treadmill exercise test at baseline.
- Baseline blood pressure systolic greater than 140 mmHg or diastolic greater than 90 mmHg on 2 measures with or without hypertensive medications. Subjects will be encouraged to seek evaluation by their primary care provider.
- Baseline fasting blood glucose greater than 126 mg/dl, if subject previously undiagnosed as being diabetic. Subjects will be encouraged to seek evaluation by their primary care provider.
- Baseline fasting LDL greater than 190 mg/dl. Subjects will be encouraged to seek evaluation by their primary care provider.
- Physically unable to perform the Keep the Beat program due to neurologic or orthopedic conditions.
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 | Procedure or surgery | – |
Primary outcome
Improvement in brachial artery dilator responsiveness to shear stress as a bioassay for endothelium-dependent nitric oxide bioavailability following 3 months participation in the Keep the Beat program as compared with baseline measuraements.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jul 2017.
- Background: PubMed 1599603Blair SN, Kohl HW, Gordon NF, Paffenbarger RS Jr. How much physical activity is good for health? Annu Rev Public Health. 1992;13:99-126. doi: 10.1146/annurev.pu.13.050192.000531.
- Background: PubMed 15724141Hu G, Tuomilehto J, Silventoinen K, Barengo NC, Peltonen M, Jousilahti P. The effects of physical activity and body mass index on cardiovascular, cancer and all-cause mortality among 47 212 middle-aged Finnish men and women. Int J Obes (Lond). 2005 Aug;29(8):894-902. doi: 10.1038/sj.ijo.0802870.
- Background: PubMed 15760296Brownson RC, Boehmer TK, Luke DA. Declining rates of physical activity in the United States: what are the contributors? Annu Rev Public Health. 2005;26:421-43. doi: 10.1146/annurev.publhealth.26.021304.144437.
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Exercise in people with Vascular Formation, run by National Heart, Lung, and Blood Institute (NHLBI) 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 3 inclusion and 8 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: finished, as of the sponsor's last update on 2 Jul 2017. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in brachial artery dilator responsiveness to shear stress as a bioassay for endothelium-dependent nitric oxide bioavailability following 3 months participation in the Keep the Beat program as compared with baseline measuraements.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00246883, which also lists 3 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 2 Jul 2017.