Sedentary BehaviorNCT04207333
Combined Effects of Prolonged Sitting and Mental Stress on the Cardiovascular System
A study testing Mental Arithmetic Test in people with Sedentary Behavior and Cardiovascular Risk Factor, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Cardiovascular Risk Factor, Mental Stress
- What is being tested?
- Mental Arithmetic Test
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jan 2020to 1 Jun 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female
Who cannot join
- Any known cardio-metabolic disorders
- Taking medications known to affect cardiovascular function
- Report drug or alcohol abuse
- Report cigarette smoking
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: 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.
Read the 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.
- Conditions
- Sedentary Behavior, Cardiovascular Risk Factor, Mental Stress, Cognitive Change, Cerebrovascular Insufficiency
- Being tested
- Mental Arithmetic Test
- Medical subject headings
- Sedentary Behavior, Stress, Psychological, Cerebrovascular Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental Arithmetic TestBehavioural
Also called Mental Stressor
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Mental Arithmetic Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline and immediately following the acute mental stressor
Secondary outcomes (5)
Mean Change Carotid-femoral Pulse Wave Velocity (PWV)
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).
Measured: Baseline and immediately following the acute mental stressor
Mean Change in Femoral-ankle PWV
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).
Measured: Baseline and immediately following the acute mental stressor
Mean Change Augmentation Index
Augmentation Index is a measure of arterial wave reflection and calculated as augmentation pressure divided by central pulse pressure.
Measured: Baseline and immediately following the acute mental stressor
Mean Executive Function
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.
Measured: following the acute mental stressor
Neurovascular Coupling
Neurovascular Coupling reflects the cerebral blood flow during a cognitive task.
Measured: following the acute mental stressor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start11 Jan 2020
- Primary completion1 May 2020
- Study completion1 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Participants will be exposed to mental stress following either 20 min or 120 min sitting
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Jade Blackwell, MS, Principal investigator, University of North Carolina, Chapel HillLee Stoner, PhD, MPH, Study director, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04207333
- Sponsor's protocol ID
- 19-1843
- Other IDs
- 2KR1211907
- Status last verified
- Mar 2020
- First submitted
- 16 Dec 2019
- Last updated
- 18 Apr 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Combined Effects of Prolonged Sitting and Mental Stress on Vascular and Cerebrovascular Function in Middle-Aged Adults
- ClinicalTrials.gov ID
- NCT04207333
- Acronym / sponsor ID
- 19-1843
- Conditions
- Sedentary Behavior, Cardiovascular Risk Factor, Mental Stress, Cognitive Change, Cerebrovascular Insufficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- North Carolina Translational and Clinical Sciences Institute
- Study start
- 11 Jan 2020 (actual)
- Primary completion
- 1 May 2020 (actual)
- Study completion
- 1 Jun 2020 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Posted 23 Apr 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be exposed to mental stress following either 20 min or 120 min sitting
| Arm | Type | Receives |
|---|---|---|
| Prolonged Sitting + Mental Stress, Then Brief Sitting + Mental Stress | Experimental | Behavioral: Mental Arithmetic TestParticipants 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. |
| Brief Sitting + Mental Stress, Then Prolonged Sitting + Mental Stress | Experimental | Behavioral: Mental Arithmetic TestFollowing 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. |
Who may qualify
- Ages
- 35 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Healthy male or female
Key exclusion criteria (5 listed)
- Any known cardio-metabolic disorders
- Taking medications known to affect cardiovascular function
- Report drug or alcohol abuse
- Report cigarette smoking
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mental Arithmetic TestAlso: Mental StressorThe 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 | Behavioural | Brief Sitting + Mental Stress, Then Prolonged Sitting + Mental Stress, Prolonged Sitting + Mental Stress, Then Brief Sitting + Mental Stress |
Primary outcome
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).
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).
5 secondary outcomes
Mean Change Carotid-femoral Pulse Wave Velocity (PWV)
Time frame: Baseline and immediately following the acute mental stressor
Mean Change in Femoral-ankle PWV
Time frame: Baseline and immediately following the acute mental stressor
Mean Change Augmentation Index
Time frame: Baseline and immediately following the acute mental stressor
Mean Executive Function
Time frame: following the acute mental stressor
Neurovascular Coupling
Time frame: following the acute mental stressor
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jade Blackwell, MS principal investigator
University of North Carolina, Chapel Hill
Lee Stoner, PhD, MPH study director
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mental Arithmetic Test in people with Sedentary Behavior and Cardiovascular Risk Factor, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 23 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean Change in Brachial-femoral Pulse Wave Velocity (bfPWV) (time frame: Baseline and immediately following the acute mental stressor). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2023.