AgingEPC-ExNCT01169831
Regulation of Endothelial Progenitor Cells by Short-Term Exercise
A study testing Exercise Training and Exercise Cessation in people with Aging and Exercise, run by Baltimore VA Medical Center at 1 site in United States.
Trial summary
Endothelial Progenitor Cells (EPCs) are circulating cells released from bone marrow which are important for maintaining cardiovascular health. The prevalence of cardiovascular disease in older adults is associated with reduced circulating EPC numbers. Studies have shown reduced EPC number and function in old vs. Read more about this study
- Who is it for?
- Ages 50 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging, Exercise, Cardiovascular Disease
- What is being tested?
- Exercise Training and Exercise Cessation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2011to 31 Jul 2024
- Phase
- Interventional
- 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 50 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50-80 years of age, BMI = 18-35 kg/m2, non-smoking, women must be postmenopausal
Who cannot join
- history of cardiovascular/cerebrovascular disease, diabetes, cancer, renal, liver disease, HIV; uncontrolled hyperlipidemia/hypertension
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore & Baltimore VA Medical Center
Baltimore, Maryland, 21201
About this study
Endothelial Progenitor Cells (EPCs) are circulating cells released from bone marrow which are important for maintaining cardiovascular health. The prevalence of cardiovascular disease in older adults is associated with reduced circulating EPC numbers. Studies have shown reduced EPC number and function in old vs. young individuals, and endurance exercise training increases EPC number and function in young adults. Oxidative stress adversely affects endothelial cells and preliminary evidence indicates that oxidative stress negatively affects EPC function. Conversely, regular exercise reduces markers of oxidative stress and may enhance EPC function in older adults. The investigators hypothesize that older endurance-trained athletes and matched sedentary individuals will have markedly divergent EPC function and that altering the physical activity levels of both groups will move them to intermediate points between these two extremes. The investigators also propose that the investigators can "mimic" the effect of exercise training on EPC function in cell culture by altering intracellular levels of a key enzyme and a signaling molecule which the investigators have shown to regulate EPC function with respect to exercise training in young individuals.
- Conditions
- Aging, Exercise, Cardiovascular Disease
- Being tested
- Exercise Training, Exercise Cessation
- Medical subject headings
- Motor Activity, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise TrainingOther
2 weeks of daily aerobic exercise training
Exercise CessationOther
Stopping all exercise for 2 weeks
| Study group | Role | What they receive |
|---|---|---|
| Sedentary Older Adults | Experimental | Not described Receives: Other: Exercise Training |
| Older Endurance Athletes | Experimental | Not described Receives: Other: Exercise Cessation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline Endothelial progenitor cell number
Measured: Day 1
Final Endothelial Progenitor Cell Number
Measured: Day 15
Secondary outcomes (2)
Baseline Endothelial Reactivity
Measured: Day 1
Final Endothelial Reactivity
Measured: Day 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2010 (estimated)
- Study startJul 2011
- Primary completionNov 2014
- Study completion31 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Collaborators
- University of Maryland, Baltimore, University of Maryland, College Park
- Responsible party
- Principal investigator, Steven J. Prior, Ph.D., University of Maryland, Baltimore
- Investigators
- Steven J Prior, Ph.D., Principal investigator, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01169831
- Sponsor's protocol ID
- HP-00045413
- Acronym
- EPC-Ex
- Status last verified
- Aug 2024
- First submitted
- 23 Jul 2010
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regulation of Endothelial Progenitor Cells by Short-Term Exercise
- ClinicalTrials.gov ID
- NCT01169831
- Acronym / sponsor ID
- EPC-Ex / HP-00045413
- Conditions
- Aging, Exercise, Cardiovascular Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Collaborators
- University of Maryland, Baltimore, University of Maryland, College Park
- Study start
- Jul 2011
- Primary completion
- Nov 2014 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 26 Jul 2010 (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.
Endothelial Progenitor Cells (EPCs) are circulating cells released from bone marrow which are important for maintaining cardiovascular health. The prevalence of cardiovascular disease in older adults is associated with reduced circulating EPC numbers. Studies have shown reduced EPC number and function in old vs. young individuals, and endurance exercise training increases EPC number and function in young adults. Oxidative stress adversely affects endothelial cells and preliminary evidence indicates that oxidative stress negatively affects EPC function. Conversely, regular exercise reduces markers of oxidative stress and may enhance EPC function in older adults. The investigators hypothesize that older endurance-trained athletes and matched sedentary individuals will have markedly divergent EPC function and that altering the physical activity levels of both groups will move them to intermediate points between these two extremes. The investigators also propose that the investigators can "mimic" the effect of exercise training on EPC function in cell culture by altering intracellular levels of a key enzyme and a signaling molecule which the investigators have shown to regulate EPC function with respect to exercise training in young individuals.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sedentary Older Adults | Experimental | Other: Exercise Training |
| Older Endurance Athletes | Experimental | Other: Exercise Cessation |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 50-80 years of age, BMI = 18-35 kg/m2, non-smoking, women must be postmenopausal
Key exclusion criteria (1 listed)
- history of cardiovascular/cerebrovascular disease, diabetes, cancer, renal, liver disease, HIV; uncontrolled hyperlipidemia/hypertension
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 Training2 weeks of daily aerobic exercise training | Other | Sedentary Older Adults |
| Exercise CessationStopping all exercise for 2 weeks | Other | Older Endurance Athletes |
Primary outcome
Baseline Endothelial progenitor cell number
Time frame: Day 1
Final Endothelial Progenitor Cell Number
Time frame: Day 15
2 secondary outcomes
Baseline Endothelial Reactivity
Time frame: Day 1
Final Endothelial Reactivity
Time frame: Day 15
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 22 Aug 2024.
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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.
Steven J Prior, Ph.D. principal investigator
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Training and Exercise Cessation in people with Aging and Exercise, run by Baltimore VA Medical Center 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 1 inclusion and 1 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 22 Aug 2024. 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?
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?
Baseline Endothelial progenitor cell number (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2024.