- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06163456
Influence of Cardiorespiratory Fitness and Body Composition on Resting and Post-exercise Indices of Vascular Health in Young Adults
November 30, 2023 updated by: Rian Q. Landers-Ramos, Towson University
This research is being done to determine whether acute exercise causes differences in numbers of novel blood factors associated with vascular health in college-aged adults across different physical activity habits.
As only ~50% of cardiovascular (CV) events can be explained by traditional CV risk factors such as high blood pressure and high cholesterol, it is anticipated that this research will provide a more comprehensive look into novel risk factors that may better explain CV risk and that may be modifiable through regular physical activity.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
43
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Maryland
-
Towson, Maryland, United States, 21252-0001
- Towson University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- 18-29 years of age; healthy male and female; Physically inactive, defined as participation in less than 20 min of continuous endurance exercise on fewer than 2 days/week; Recreationally active, defined as participation in 30 min/day of moderate-intensity cardiovascular activity on greater than 4 days/week; Highly active- defined as performing 30-60 min of moderate- to vigorous-intensity endurance exercise greater than 5 days/week.
Exclusion Criteria:
- currently pregnant, previously diagnosed coronary heart disease or congenital heart disease, serum total cholesterol >200 mg/dl, low-density lipoprotein cholesterol >130 mg/dl, high-density lipoprotein cholesterol < 35 mg/dl, fasting glucose >100 mg/dl, systolic blood pressure > 130 mmHg, diastolic blood pressure >90 mmHg, and BMI >30 kg/m2.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: low fitness
|
30 min of treadmill running at 70% of the participants maximal oxygen consumption
|
|
Active Comparator: moderate fitness
|
30 min of treadmill running at 70% of the participants maximal oxygen consumption
|
|
Active Comparator: high fitness
|
30 min of treadmill running at 70% of the participants maximal oxygen consumption
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
endothelial function
Time Frame: Baseline and 60 min post-exercise
|
flow-mediated dilation
|
Baseline and 60 min post-exercise
|
|
arterial stiffness
Time Frame: Baseline and 60 min post-exercise
|
augmentation index
|
Baseline and 60 min post-exercise
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Rian Q Landers-Ramos, PhD, Towson University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 2, 2019
Primary Completion (Actual)
March 15, 2020
Study Completion (Actual)
November 29, 2023
Study Registration Dates
First Submitted
November 30, 2023
First Submitted That Met QC Criteria
November 30, 2023
First Posted (Estimated)
December 8, 2023
Study Record Updates
Last Update Posted (Estimated)
December 8, 2023
Last Update Submitted That Met QC Criteria
November 30, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- 1810041426
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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