Regulation of Endothelial Progenitor Cells by Short-Term Exercise (EPC-Ex)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Baltimore VA Medical Center
University of Maryland
Information provided by (Responsible Party):
Steven J. Prior, Ph.D., Baltimore VA Medical Center
ClinicalTrials.gov Identifier:
NCT01169831
First received: July 23, 2010
Last updated: January 26, 2015
Last verified: January 2015
  Purpose

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.


Condition Intervention
Aging
Exercise
Cardiovascular Disease
Other: Exercise Training
Other: Exercise Cessation

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Regulation of Endothelial Progenitor Cells by Short-Term Exercise

Resource links provided by NLM:


Further study details as provided by Baltimore VA Medical Center:

Primary Outcome Measures:
  • Baseline Endothelial progenitor cell number [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Final Endothelial Progenitor Cell Number [ Time Frame: Day 15 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Baseline Endothelial Reactivity [ Time Frame: Day 1 ] [ Designated as safety issue: No ]
  • Final Endothelial Reactivity [ Time Frame: Day 15 ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: July 2011
Estimated Study Completion Date: November 2015
Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Sedentary Older Adults Other: Exercise Training
2 weeks of daily aerobic exercise training
Experimental: Older Endurance Athletes Other: Exercise Cessation
Stopping all exercise for 2 weeks

  Eligibility

Ages Eligible for Study:   50 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 50-80 years of age, BMI = 18-35 kg/m2, non-smoking, women must be postmenopausal

Exclusion Criteria:

  • history of cardiovascular/cerebrovascular disease, diabetes, cancer, renal, liver disease, HIV; uncontrolled hyperlipidemia/hypertension
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01169831

Locations
United States, Maryland
University of Maryland, Baltimore & Baltimore VA Medical Center
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
University of Maryland, Baltimore County
Baltimore VA Medical Center
University of Maryland
Investigators
Principal Investigator: Steven J Prior, Ph.D. University of Maryland, Baltimore County
  More Information

Additional Information:
No publications provided

Responsible Party: Steven J. Prior, Ph.D., Assistant Professor, Baltimore VA Medical Center
ClinicalTrials.gov Identifier: NCT01169831     History of Changes
Other Study ID Numbers: HP-00045413
Study First Received: July 23, 2010
Last Updated: January 26, 2015
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on March 25, 2015