Combined Effects of Prolonged Sitting and Mental Stress on the Cardiovascular System

NCT04207333 | Completed Results

• 2 other identifiers: 19-18432KR1211907
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sedentary Behavior; Cardiovascular Risk Factor; Mental Stress; Cognitive Change; Cerebrovascular Insufficiency

Outcome Measures

Primary Outcomes (2)

• Mean Change in Brachial-femoral Pulse Wave Velocity (bfPWV)

  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)

  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 Outcomes (5)

• Mean Change Carotid-femoral Pulse Wave Velocity (PWV)

  Baseline and immediately following the acute mental stressor

• Mean Change in Femoral-ankle PWV

  Baseline and immediately following the acute mental stressor

• Mean Change Augmentation Index

  Baseline and immediately following the acute mental stressor

• Mean Executive Function

  following the acute mental stressor

• Neurovascular Coupling

  following the acute mental stressor

Study Arms (2)

Prolonged Sitting + Mental Stress, Then Brief Sitting + Mental Stress

EXPERIMENTAL

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.

Behavioral: Mental Arithmetic Test

Brief Sitting + Mental Stress, Then Prolonged Sitting + Mental Stress

EXPERIMENTAL

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.

Behavioral: Mental Arithmetic Test

Interventions

Mental Arithmetic Test BEHAVIORAL

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

Also known as: Mental Stressor

Brief Sitting + Mental Stress, Then Prolonged Sitting + Mental Stress; Prolonged Sitting + Mental Stress, Then Brief Sitting + Mental Stress

Eligibility Criteria

• Age: 35 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy male or female

You may not qualify if:

• Any known cardio-metabolic disorders
• Taking medications known to affect cardiovascular function
• Report drug or alcohol abuse
• Report cigarette smoking
• Pregnant women

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• North Carolina Translational and Clinical Sciences Institute: collaborator

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

MeSH Terms

Conditions

Sedentary Behavior; Stress, Psychological; Cerebrovascular Disorders

Condition Hierarchy (Ancestors)

Behavior; Behavioral Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases

Results Point of Contact

• Title: Lee Stoner, PhD, MPH
• Organization: University of North Carolina at Chapel Hill

stonerl@unc.edu

919-962-0534

Study Officials

• Jade Blackwell, MS

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

• Lee Stoner, PhD, MPH

  University of North Carolina, Chapel Hill

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be exposed to mental stress following either 20 min or 120 min sitting

Study Record Dates

• First Submitted: December 16, 2019
• First Posted: December 20, 2019
• Study Start: January 11, 2020
• Primary Completion: May 1, 2020
• Study Completion: June 1, 2020
• Last Updated: April 18, 2023
• Results First Posted: April 23, 2021

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: One year after study completion.
• 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.

Locations

US (1)