Trial Outcomes & Findings for Combined Effects of Prolonged Sitting and Mental Stress on the Cardiovascular System (NCT NCT04207333)
NCT ID: NCT04207333
Last Updated: 2023-04-18
Results Overview
bfPWV (m/s) is the velocity at which a pressure wave travels between the brachial and femoral arterial segments. An increase in bfPWV represents increased arterial stiffness (worse outcome).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
6 participants
Primary outcome timeframe
Baseline and immediately following the acute mental stressor
Results posted on
2023-04-18
Participant Flow
Participant milestones
| Measure |
Prolonged Sitting + Mental Stress, Then Brief Sitting + Mental Stress
Participants will sit for 120 min prior to being exposed to mental stress Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 120 minutes while watching a documentary. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test. Following a 2-7 day wash-out period, participants will be exposed to the other condition (brief sitting, followed by mental stress). For this condition participants will rest in the supine position for 10 minutes, then will be switched to an upright seated position. Following the 10 minutes quiet rest in the seated position, participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
Brief Sitting + Mental Stress, Then Prolonged Sitting + Mental Stress
Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 10 minutes. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test. Following a 2-7 day wash-out period, participants will be exposed to the other condition (prolonged sitting, followed by mental stress). For this condition participants will rest in the supine position for 10 minutes, then will be switched to an upright seated position. Participants will sit quietly for 120 min while watching a documentary, following which the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
|---|---|---|
|
First Intervention (Single 1-Day Visit)
STARTED
|
3
|
3
|
|
First Intervention (Single 1-Day Visit)
COMPLETED
|
3
|
3
|
|
First Intervention (Single 1-Day Visit)
NOT COMPLETED
|
0
|
0
|
|
Washout (2-7 Days)
STARTED
|
3
|
3
|
|
Washout (2-7 Days)
COMPLETED
|
3
|
3
|
|
Washout (2-7 Days)
NOT COMPLETED
|
0
|
0
|
|
Second Intervention (Single 1-Day Visit)
STARTED
|
3
|
3
|
|
Second Intervention (Single 1-Day Visit)
COMPLETED
|
3
|
3
|
|
Second Intervention (Single 1-Day Visit)
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
All Participants
n=6 Participants
All participants who completed both conditions in either Period 1 or Period 2 or Period 3 as per randomization schedule.
|
|---|---|
|
Age, Continuous
|
43 years
STANDARD_DEVIATION 8.0 • n=6 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=6 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=6 Participants
|
|
Region of Enrollment
United States
|
6 Participants
n=6 Participants
|
PRIMARY outcome
Timeframe: Baseline and immediately following the acute mental stressorbfPWV (m/s) is the velocity at which a pressure wave travels between the brachial and femoral arterial segments. An increase in bfPWV represents increased arterial stiffness (worse outcome).
Outcome measures
| Measure |
Prolonged Sitting With Mental Stress
n=6 Participants
Participants will sit for 120 min prior to being exposed to mental stress Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 120 minutes while watching a documentary. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
Brief Sitting With Mental Stress
n=6 Participants
Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 10 minutes. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
|---|---|---|
|
Mean Change in Brachial-femoral Pulse Wave Velocity (bfPWV)
|
-0.26 m/s
Standard Error 0.56
|
0.22 m/s
Standard Error 0.56
|
PRIMARY outcome
Timeframe: Baseline and immediately following the acute mental stressorBrain PWV (cm/s) is the velocity at which a pressure wave travels between the heart and cerebrovascular system. An increase in Brain PWV represents increased arterial stiffness (worse outcome).
Outcome measures
| Measure |
Prolonged Sitting With Mental Stress
n=6 Participants
Participants will sit for 120 min prior to being exposed to mental stress Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 120 minutes while watching a documentary. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
Brief Sitting With Mental Stress
n=6 Participants
Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 10 minutes. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
|---|---|---|
|
Change in Heart-middle Cerebral Artery Pulse Wave Velocity (Brain PWV)
|
6.1 cm/s
Standard Error 2.8
|
-0.97 cm/s
Standard Error 2.8
|
SECONDARY outcome
Timeframe: Baseline and immediately following the acute mental stressorCarotid PWV (m/s) is the velocity at which a pressure wave travels between the carotid and femoral arterial segments. An increase in carotid PWV represents increased arterial stiffness (worse outcome).
Outcome measures
| Measure |
Prolonged Sitting With Mental Stress
n=6 Participants
Participants will sit for 120 min prior to being exposed to mental stress Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 120 minutes while watching a documentary. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
Brief Sitting With Mental Stress
n=6 Participants
Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 10 minutes. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
|---|---|---|
|
Mean Change Carotid-femoral Pulse Wave Velocity (PWV)
|
-0.26 m/s
Standard Error 0.56
|
0.22 m/s
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Baseline and immediately following the acute mental stressorFemoral-ankle PWV (m/s) is the velocity at which a pressure wave travels between the femoral-ankle arterial segments. An increase in femoral-ankle PWV represents increased arterial stiffness (worse outcome).
Outcome measures
| Measure |
Prolonged Sitting With Mental Stress
n=6 Participants
Participants will sit for 120 min prior to being exposed to mental stress Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 120 minutes while watching a documentary. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
Brief Sitting With Mental Stress
n=6 Participants
Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 10 minutes. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
|---|---|---|
|
Mean Change in Femoral-ankle PWV
|
1.28 m/s
Standard Error 1.00
|
1.20 m/s
Standard Error 1.00
|
SECONDARY outcome
Timeframe: Baseline and immediately following the acute mental stressorAugmentation Index is a measure of arterial wave reflection and calculated as augmentation pressure divided by central pulse pressure.
Outcome measures
| Measure |
Prolonged Sitting With Mental Stress
n=6 Participants
Participants will sit for 120 min prior to being exposed to mental stress Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 120 minutes while watching a documentary. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
Brief Sitting With Mental Stress
n=6 Participants
Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 10 minutes. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
|---|---|---|
|
Mean Change Augmentation Index
|
-1.83 percentage of pulse pressure
Standard Error 4.25
|
-1.92 percentage of pulse pressure
Standard Error 4.25
|
SECONDARY outcome
Timeframe: following the acute mental stressorExecutive Function was measured at the end of each condition by recording the completion time of a trail making test. The trail making test was delivered using a tablet and the time to complete the test was recorded. Subject instructed to connect a set of 25 dots as rapidly as possible.
Outcome measures
| Measure |
Prolonged Sitting With Mental Stress
n=6 Participants
Participants will sit for 120 min prior to being exposed to mental stress Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 120 minutes while watching a documentary. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
Brief Sitting With Mental Stress
n=6 Participants
Following 10 minutes of supine rest, participants will switch to an upright sitting position and remain seated for 10 minutes. Following the 10 minutes quiet rest the participants will be subjected to a 5 minute mental arithmetic test.
Mental Arithmetic Test: The researcher will call out a four-digit number and ask the participant to subtract either 7 or 13. Each minute, a new four-digit number will be called out and the participant must subtract the 7 or 13 from the number. The test will last approximately 5 minutes
|
|---|---|---|
|
Mean Executive Function
|
48.7 sec
Standard Deviation 20.2
|
76.2 sec
Standard Deviation 75.2
|
SECONDARY outcome
Timeframe: following the acute mental stressorPopulation: This data was not collected.
Neurovascular Coupling reflects the cerebral blood flow during a cognitive task.
Outcome measures
Outcome data not reported
Adverse Events
Prolonged Sitting With Mental Stress
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Brief Sitting With Mental Stress
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
Lee Stoner, PhD, MPH
University of North Carolina at Chapel Hill
Phone: 919-962-0534
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place