NCT01169831

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2011

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 23, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 26, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

July 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
9.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2024

Completed
Last Updated

August 22, 2024

Status Verified

August 1, 2024

Enrollment Period

3.3 years

First QC Date

July 23, 2010

Last Update Submit

August 20, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Baseline Endothelial progenitor cell number

    Day 1

  • Final Endothelial Progenitor Cell Number

    Day 15

Secondary Outcomes (2)

  • Baseline Endothelial Reactivity

    Day 1

  • Final Endothelial Reactivity

    Day 15

Study Arms (2)

Sedentary Older Adults

EXPERIMENTAL
Other: Exercise Training

Older Endurance Athletes

EXPERIMENTAL
Other: Exercise Cessation

Interventions

2 weeks of daily aerobic exercise training

Sedentary Older Adults

Stopping all exercise for 2 weeks

Older Endurance Athletes

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • history of cardiovascular/cerebrovascular disease, diabetes, cancer, renal, liver disease, HIV; uncontrolled hyperlipidemia/hypertension

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Maryland, Baltimore & Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Motor ActivityCardiovascular Diseases

Interventions

Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Steven J Prior, Ph.D.

    University of Maryland, Baltimore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
FED
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 23, 2010

First Posted

July 26, 2010

Study Start

July 1, 2011

Primary Completion

November 1, 2014

Study Completion

July 31, 2024

Last Updated

August 22, 2024

Record last verified: 2024-08

Locations