NCT03981640

Brief Summary

The goal of this clinical trials is to learn if healthy young African American (AA) adults have a larger change in their kidney blood flow during exercise compared to White (W) adults. The main questions that this study aims to answer are:

  • Do healthy young AA adults have a larger decrease in kidney blood flow during exercise compared to W adults?
  • Do healthy young AA adults have a larger decrease in kidney blood flow during other types of stress compared to W adults? During two visits in the research lab, participants will:
  • Perform a fitness test
  • Perform cycling exercise while lying down
  • Undergo a cold hand test
  • Perform a mental math test Completing this clinical trial will help researchers to understand more about why many AA adults have heart and kidney problems, so future research can study ways to reduce the number of AA adults who have these health issues.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Sep 2024

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
recruiting

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

June 4, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 11, 2019

Completed
5.3 years until next milestone

Study Start

First participant enrolled

September 30, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

December 24, 2025

Status Verified

December 1, 2025

Enrollment Period

1.5 years

First QC Date

June 4, 2019

Last Update Submit

December 22, 2025

Conditions

Keywords

ExerciseCold stressMental stress

Outcome Measures

Primary Outcomes (3)

  • Change in renal vascular resistance during acute exercise

    For the acute exercise intervention, the percent change from pre-acute exercise to during steady-state exercise will be assessed.

    Pre-acute exercise and during steady-state exercise

  • Change in renal vascular resistance during cold pressor test

    For the cold pressor test intervention, the percent change from pre-cold pressor test to 30-second intervals during the cold pressor test will be assessed.

    Pre-cold pressor test to after 30, 60, 90, and 120 seconds of cold pressor test

  • Change in renal vascular resistance during mental stress test

    For the mental stress test intervention, the percent change from pre-mental stress test to 1-minute intervals during the mental stress test will be assessed.

    Pre-mental stress test to after 1, 2, 3, 4, and 5 minutes of mental stress test

Secondary Outcomes (24)

  • Change in renal blood flow velocity during acute exercise

    Pre-acute exercise and during steady-state exercise

  • Change in mean arterial blood pressure during acute exercise

    Pre-acute exercise and during steady-state exercise

  • Change in systolic blood pressure during acute exercise

    Pre-acute exercise and during steady-state exercise

  • Change in diastolic blood pressure during acute exercise

    Pre-acute exercise and during steady-state exercise

  • Change in heart rate during acute exercise

    Pre-acute exercise and during steady-state exercise

  • +19 more secondary outcomes

Other Outcomes (4)

  • Rating of perceived exertion during acute exercise

    During last 30 seconds of steady-state exercise

  • Rating of hand pain during cold pressor test

    During last 30 seconds of cold pressor test

  • Rating of cold perception during cold pressor test

    During last 30 seconds of cold pressor test

  • +1 more other outcomes

Study Arms (2)

African American Adults

EXPERIMENTAL

African American adults will undergo the interventions of acute exercise, a cold pressor test, and a mental stress test while beat-to-beat renal blood flow velocity, mean arterial blood pressure, and heart rate are recorded.

Other: Acute exerciseOther: Cold pressor testOther: Mental stress test

White Adults

EXPERIMENTAL

White adults will undergo the interventions of acute exercise, a cold pressor test, and a mental stress test while beat-to-beat renal blood flow velocity, mean arterial blood pressure, and heart rate are recorded.

Other: Acute exerciseOther: Cold pressor testOther: Mental stress test

Interventions

Participants will lie in a semi-supine position with their feet attached to the pedals of a custom-arranged cycle ergometer. Participants' 40% heart rate reserve will be calculated, giving the target value to achieve during exercise based on appropriate resistance applied on the cycle ergometer, corresponding to a moderate exercise intensity. After a 5-minute resting baseline, participants will perform dynamic cycling exercise at steady state for up to 20 minutes. They will then stop exercising, and there will be a 5-minute recovery period. Beat-to-beat renal blood flow velocity (Doppler ultrasound), mean arterial blood pressure (finger photoplethysmographic cuff), and heart rate (electrocardiogram) will be recorded throughout. A rating of perceived exertion will be taken from participants during the last 30 seconds of steady-state cycling exercise.

African American AdultsWhite Adults

Participants will lie in a semi-supine position, and after a 3-minute resting baseline, participants will have their hand immersed in ice water for 2 minutes. This cold pressor test represents the non-exercise, physical sympathetic stressor. Participants' hand will then be removed from the ice water, followed by a 3-minute recovery period. Beat-to-beat renal blood flow velocity (Doppler ultrasound), mean arterial blood pressure (finger photoplethysmographic cuff), and heart rate (electrocardiogram) will be recorded throughout. Ratings of hand pain and cold perception will be taken from participants during the last 30 seconds of the cold pressor test.

African American AdultsWhite Adults

Participants will lie in a semi-supine position, and after a 3-minute resting baseline, participants will perform a mental arithmetic task for 5 minutes. This mental stress test represents the non-exercise, psychological sympathetic stressor. Participants will be instructed to subtract a given number from a randomly selected three-digit number and verbally state their answer and continue to do so for the duration of the test. Participants will be instructed to state their answers as quickly and accurately as possible. Participants will then stop the arithmetic task, and a 3-minute recovery period will follow. Beat-to-beat renal blood flow velocity (Doppler ultrasound), mean arterial blood pressure (finger photoplethysmographic cuff), and heart rate (electrocardiogram) will be recorded throughout. A rating of perceived stress will be taken from participants during the last 30 seconds of the mental stress test.

African American AdultsWhite Adults

Eligibility Criteria

Age18 Years - 35 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsMale and female
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Self-report as either African American or White racial identity
  • Born in United States
  • Both biological parents identify as same racial identity as participant
  • Recreationally active (participating in physical activity for at least 20 minutes per day, at least three times per week, but not training for competitive events)
  • Fluent in English

You may not qualify if:

  • Hispanic or Latino
  • Females who are pregnant or lactating
  • Cardiovascular or renal disease
  • Hypertension (blood pressure of more than or equal to 130/80 mmHg)
  • Diabetes
  • Obesity (body mass index of more than or equal to 30 kg/m2)
  • Smoker/Tobacco user
  • Acute medical conditions
  • Taking prescribed cardiovascular, antihypertensive, or renal medications

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Boston

Boston, Massachusetts, 02125, United States

RECRUITING

MeSH Terms

Conditions

Motor ActivityStress, Psychological

Interventions

Exercise

Condition Hierarchy (Ancestors)

BehaviorBehavioral Symptoms

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Rachel C Drew, PhD

    University of Massachusetts, Boston

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rachel C Drew, PhD

CONTACT

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
Associate Professor

Study Record Dates

First Submitted

June 4, 2019

First Posted

June 11, 2019

Study Start

September 30, 2024

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

December 24, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

Locations