NCT06163456

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
43

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Dec 2019

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

Study Start

First participant enrolled

December 2, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 15, 2020

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 29, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

November 30, 2023

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 8, 2023

Completed
Last Updated

December 8, 2023

Status Verified

November 1, 2023

Enrollment Period

3 months

First QC Date

November 30, 2023

Last Update Submit

November 30, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • endothelial function

    flow-mediated dilation

    Baseline and 60 min post-exercise

  • arterial stiffness

    augmentation index

    Baseline and 60 min post-exercise

Study Arms (3)

low fitness

EXPERIMENTAL
Other: Acute submaximal exercise

moderate fitness

ACTIVE COMPARATOR
Other: Acute submaximal exercise

high fitness

ACTIVE COMPARATOR
Other: Acute submaximal exercise

Interventions

30 min of treadmill running at 70% of the participants maximal oxygen consumption

high fitnesslow fitnessmoderate fitness

Eligibility Criteria

Age18 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Towson University

Towson, Maryland, 21252-0001, United States

Location

Study Officials

  • Rian Q Landers-Ramos, PhD

    Towson University

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

November 30, 2023

First Posted

December 8, 2023

Study Start

December 2, 2019

Primary Completion

March 15, 2020

Study Completion

November 29, 2023

Last Updated

December 8, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations