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Sedentary Behavior, Cardiovascular Function, and Sleep

Sedentary Behavior, Cardiovascular Function, and Sleep

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04137068
Acronym
PACE
Enrollment
20
Registered
2019-10-23
Start date
2019-11-13
Completion date
2023-03-31
Last updated
2022-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Function, Sedentary Behavior, Sleep

Keywords

Physical Activity, Sleep, Sedentary, Cardiovascular

Brief summary

This is an interventional study that will examine how sedentary behavior (decreased physical inactivity) over time affects cardiovascular health (i.e. heart rate and blood pressure) and sleep quality/duration.

Detailed description

PRIMARY OBJECTIVES: 1\. To test the hypothesis that two weeks of sedentary behavior will progressively impair vascular endothelial function. 2: To test the hypothesis that increasing sedentary behavior will decrease total sleep duration and sleep efficiency. 3: To test the hypothesis that two-weeks of sedentary behavior will progressively increase 24-h blood pressure and reduce nocturnal blood pressure dipping. OUTLINE: After a baseline period, participants will become more inactive and also come in for 4-h uninterrupted sitting visits. Cardiovascular, activity, and sleep measures will be taken throughout.

Interventions

Participants reduce their activity level to \<5,000 steps/day and \<50 % of baseline steps.

Sponsors

Oregon Health and Science University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

* Ages 20-80y * Lean and overweight (BMI 18.5-40 kg/m2) * No acute, chronic, or debilitating medical conditions * No prescription/non-prescription medications or drugs of abuse * Limited weight training or intense exercise (swimming, CrossFit) * Non-smoker * Average level of daily physical activity (8,000-12,499 steps/day) * Persons who fit all the above criteria and are suitable based on a medical history and health habits questionnaire, sleep profiling questionnaire, and electrocardiogram and clinical biochemical screening tests of blood and urine may be eligible to participate.

Exclusion criteria

* Persons with any acute, chronic, or debilitating medical condition except pre-hypertension and/or mild to moderate sleep apnea will be excluded. * Persons with any symptoms of acute or active illness (e.g. fever, leukocytosis) will be excluded. * Persons with a history of severe psychiatric illness or psychiatric disorders will be excluded. * Persons with a history of regular night/or rotating shift work, or who have traveled more than three time zones during the one month prior to the study will be excluded. * Pregnant persons, decisionally impaired adults, and prisoners will be excluded.

Design outcomes

Primary

MeasureTime frameDescription
Endothelial Function3 weeksInvestigators will measure endothelial function as flow-mediated dilation at baseline, and each hour of the 3-hour sitting trials.
Oxidative stress3 weeksOxidative stress will be measured using malondialdehyde adducts (MDA) from Ethylenediaminetetraacetic acid (EDTA) plasma.
Endothelin-13 weeksEndothelin 1 (ET-1) will be measured from Ethylenediaminetetraacetic acid (EDTA) plasma.
Heart rate3 weeksDuring the weekly trials, heart rate will be measured as beats per minute while participants are in a seated position during the prolonged sitting period.
Blood pressure3 weeksDuring the weekly trials, blood pressure will be measured as systolic over diastolic in a seated position in the dominant arm
24-hour BP measurement3 weeksInvestigators will measure 24-hour ambulatory blood pressure monitoring (AMBP, Spacelabs, Inc) at baseline and for 24-h before each in-lab visit.
Sleep duration3 weeksSleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.
Sleep efficiency3 weeksSleep efficiency will be scored from the ActiGraph and correlated with the sleep and activity diary.
Activity3 weeksActivity will be scored from the ActiGraph and correlated with the sleep and activity diary.
Activity Perception3 weeksActivity perception will be measured before each prolonged sitting trial using an Activity Perception questionnaire (Perception of Current Activity Questionnaire). The questionnaire has 7 questions with answers ranging from 1 to 5. The range of scores is from 7 to 35, with 7 suggesting a strong negative perception of current activity, and 35 suggesting a strong positive perception of current activity.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026