Trial Outcomes & Findings for Vascular Dysfunction During Physical Inactivity (NCT NCT04872998)

NCT ID: NCT04872998

Last Updated: 2026-01-20

Results Overview

The flow rate of brachial artery measured by flow-mediated dilation (FDM). Doppler ultrasound will be used to determine brachial artery vascular function. Specifically, this assessment will include the measurement of flow rate and artery diameter at rest and in response to flow mediated dilation.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)

Results posted on

2026-01-20

Participant Flow

Participant milestones

Participant milestones
Measure
Reduced Activity
Reduction of daily step count by 70% for two weeks Step Count Reduction: Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor
Overall Study
STARTED
14
Overall Study
COMPLETED
14
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Vascular Dysfunction During Physical Inactivity

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Reduced Activity
n=14 Participants
Reduction of daily step count by 70% for two weeks Step Count Reduction: Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor
Age, Continuous
70 years
STANDARD_DEVIATION 8 • n=37 Participants
Sex: Female, Male
Female
8 Participants
n=37 Participants
Sex: Female, Male
Male
6 Participants
n=37 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=37 Participants
Race (NIH/OMB)
Asian
0 Participants
n=37 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=37 Participants
Race (NIH/OMB)
Black or African American
0 Participants
n=37 Participants
Race (NIH/OMB)
White
14 Participants
n=37 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=37 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=37 Participants

PRIMARY outcome

Timeframe: Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)

The flow rate of brachial artery measured by flow-mediated dilation (FDM). Doppler ultrasound will be used to determine brachial artery vascular function. Specifically, this assessment will include the measurement of flow rate and artery diameter at rest and in response to flow mediated dilation.

Outcome measures

Outcome measures
Measure
Reduced Activity
n=14 Participants
Reduction of daily step count by 70% for two weeks Step Count Reduction: Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor
Brachial Artery Vascular Function
Baseline FMD
5.1 percent vasodilation
Standard Deviation 5.1
Brachial Artery Vascular Function
During reduced activity
3.1 percent vasodilation
Standard Deviation 2.4
Brachial Artery Vascular Function
2 week post reduced activity
4.4 percent vasodilation
Standard Deviation 3.4

SECONDARY outcome

Timeframe: Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)

Flow rate of popliteal artery measured by flow-mediated dilation (FMD). Doppler ultrasound will be used to determine popliteal artery vascular function. Specifically, this assessment will include the measurement of flow rate and artery diameter at rest and in response to flow mediated dilation.

Outcome measures

Outcome measures
Measure
Reduced Activity
n=14 Participants
Reduction of daily step count by 70% for two weeks Step Count Reduction: Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor
Popliteal Artery Vascular Function
Baseline FMD
4.5 percent vasodilation
Standard Deviation 4.5
Popliteal Artery Vascular Function
During reduced activity
2.4 percent vasodilation
Standard Deviation 2.1
Popliteal Artery Vascular Function
2 weeks post reduced activity
3.6 percent vasodilation
Standard Deviation 2.3

SECONDARY outcome

Timeframe: Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)

Flow rate of leg microvasculature assessed by passive leg movement (PLM). Doppler ultrasound will be used to determine leg microvasculature function. Specifically, this assessment will include the measurement of flow rate at rest and in response to movement.

Outcome measures

Outcome measures
Measure
Reduced Activity
n=14 Participants
Reduction of daily step count by 70% for two weeks Step Count Reduction: Subjects reduce daily step counts by approximately 70% through monitoring and recording from step-count monitor
Leg Microvascular Function
Baseline FMD
385 ml/min
Standard Deviation 313
Leg Microvascular Function
During reduced activity
311 ml/min
Standard Deviation 202
Leg Microvascular Function
2 weeks post reduced activity
412 ml/min
Standard Deviation 290

Adverse Events

Reduced Activity

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Principal Investigator Joel Trinity Associate Professor

University of Utah

Phone: 801-582-1565

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place