- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04207333
Combined Effects of Prolonged Sitting and Mental Stress on the Cardiovascular System
The Combined Effects of Prolonged Sitting and Mental Stress on Vascular and Cerebrovascular Function in Middle-Aged Adults
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study is a multi-visit (three in total) randomized crossover trial. During a single familiarization session, the research team will obtain informed consent, and will describe to participants the purposes and procedures of this study. They will then be exposed to all experimental devices on in a quiet, dimly lit and environmentally controlled room. Participants will return to the same location for two experimental conditions following these pre-assessment guidelines:
- Fasted (> 12 hours), consuming only water.
- No caffeine consumption 12 hours prior to testing.
- No vigorous exercise 24 hours prior to testing.
- No alcohol consumption 24 hours prior to testing.
Participants will arrive to the Applied Physiology Laboratory between 6:00 and 10:00 a.m. fasted (for Visit 3: 2-5 days following the Visit 2). Participants will be fasted and refrain from caffeine intake for at least 12 hours, and alcohol and strenuous physical activity for at least 24 hours prior to arrival. Upon arrival, height and weight will be recorded followed by 10 minutes of quiet rest in the supine position. During these 10 minutes, the subject will be fitted with a Near Infra-Red Spectroscopy probe on the prefrontal cortex and medial gastrocnemius. The non-invasive continuous blood pressure, transcranial doppler, and Vicorder arterial stiffness devices will also be affixed to the participant during this time period during this time. Sitting periods will begin for both conditions once all devices are attached to the participant, the subject is shifted to an upright seated position, and at least 10 minutes of supine rest has been recorded. During the control (CON) visit, subjects will undergo a brief 20 minute sitting period. For the prolonged sitting (PS) condition, subjects will be asked to sit still and quietly for 2 hours while watching a non-stimulating documentary. Each condition will receive the mental stress at the conclusion of the sitting periods in both CON and PS. After exposure to the mental stress in both conditions, data collection procedures for this protocol will be completed. Arterial stiffness measurements will be made immediately after the mental stress, and then every 5 minutes, up to 30 minutes. Brain blood flow will be assessed by ultrasound after completion of the arterial stiffness measures. Finally, a battery of cognitive tests (Verbal Fluency Test and Trails A+B tests) will be administered to the participant.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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North Carolina
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Chapel Hill, North Carolina, United States, 27599
- University of North Carolina at Chapel Hill
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Healthy male or female
Exclusion Criteria:
- Any known cardio-metabolic disorders
- Taking medications known to affect cardiovascular function
- Report drug or alcohol abuse
- Report cigarette smoking
- Pregnant women
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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 2-5 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.
|
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
Other Names:
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Experimental: 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 2-5 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.
|
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
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change in Brachial-femoral Pulse Wave Velocity (bfPWV)
Time Frame: Baseline and immediately following the acute mental stressor
|
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).
|
Baseline and immediately following the acute mental stressor
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Change in Heart-middle Cerebral Artery Pulse Wave Velocity (Brain PWV)
Time Frame: Baseline and immediately following the acute mental stressor
|
Brain 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).
|
Baseline and immediately following the acute mental stressor
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change Carotid-femoral Pulse Wave Velocity (PWV)
Time Frame: Baseline and immediately following the acute mental stressor
|
Carotid 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).
|
Baseline and immediately following the acute mental stressor
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Mean Change in Femoral-ankle PWV
Time Frame: Baseline and immediately following the acute mental stressor
|
Femoral-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).
|
Baseline and immediately following the acute mental stressor
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Mean Change Augmentation Index
Time Frame: Baseline and immediately following the acute mental stressor
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Augmentation Index is a measure of arterial wave reflection and calculated as augmentation pressure divided by central pulse pressure.
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Baseline and immediately following the acute mental stressor
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Mean Executive Function
Time Frame: following the acute mental stressor
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Executive 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.
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following the acute mental stressor
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Neurovascular Coupling
Time Frame: following the acute mental stressor
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Neurovascular Coupling reflects the cerebral blood flow during a cognitive task.
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following the acute mental stressor
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Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 19-1843
- 2KR1211907 (Other Grant/Funding Number: NCTraCS)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ANALYTIC_CODE
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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