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

Prolonged sitting may pose a public health risk through its effects on the cardiovascular system, and may lead to impaired whole-body cardiovascular health, which includes both vascular and cerebrovascular function. These effects may interact with other environmental variables, such as stress. However, no study has investigated the combined effect of a mental stressor and prolonged sitting on vascular and cerebrovascular function. The combined effect of prolonged sitting and mental stress may lead to an exacerbated effect on vascular, cerebrovascular, and executive function. The investigators hypothesize that mental stress with the addition of prolonged sitting [PS] will result in a greater increase in peripheral, central and cerebral arterial stiffness and elicit a decrease in cerebral perfusion, total blood flow to the brain, middle cerebral artery velocity and executive function, compared to mental stress without prolonged sitting [CON]. The findings from this study may result in a public health message regarding sedentary behavior and stress, and will help elucidate the mechanisms behind acute vascular, cerebrovascular, and cognitive dysfunction during prolonged sitting.

Study Overview

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

Interventional

Enrollment (Actual)

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina at Chapel Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 59 years (Adult)

Accepts Healthy Volunteers

Yes

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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:
  • Mental Stressor
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:
  • Mental Stressor

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
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

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
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
Mean Change Augmentation Index
Time Frame: Baseline and immediately following the acute mental stressor
Augmentation Index is a measure of arterial wave reflection and calculated as augmentation pressure divided by central pulse pressure.
Baseline and immediately following the acute mental stressor
Mean Executive Function
Time Frame: following the acute mental stressor
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.
following the acute mental stressor
Neurovascular Coupling
Time Frame: following the acute mental stressor
Neurovascular Coupling reflects the cerebral blood flow during a cognitive task.
following the acute mental stressor

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 11, 2020

Primary Completion (Actual)

May 1, 2020

Study Completion (Actual)

June 1, 2020

Study Registration Dates

First Submitted

December 16, 2019

First Submitted That Met QC Criteria

December 19, 2019

First Posted (Actual)

December 20, 2019

Study Record Updates

Last Update Posted (Actual)

April 18, 2023

Last Update Submitted That Met QC Criteria

March 23, 2023

Last Verified

March 1, 2020

More Information

Terms related to this study

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)?

YES

IPD Plan Description

Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with the University of North Carolina.

IPD Sharing Time Frame

One year after study completion.

IPD Sharing Access Criteria

After the results of the research questions outlined in the grant are published, the investigators will share the study protocol, statistical analysis plan, analytical plan, and deidentified data. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cognitive Change

Clinical Trials on Mental Arithmetic Test

3
Subscribe