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.
COMPLETED
NA
14 participants
Baseline, during reduced activity (2 weeks) and 2 weeks post reduced activity (4 weeks)
2026-01-20
Participant Flow
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
| 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
| 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
| 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
| 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 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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place