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Clinical Trials/NCT04137068
NCT04137068
Unknown
N/A

Sedentary Behavior, Cardiovascular Function, and Sleep

Oregon Health and Science University1 site in 1 country20 target enrollmentNovember 13, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Sedentary Behavior
Sponsor
Oregon Health and Science University
Enrollment
20
Locations
1
Primary Endpoint
Endothelial Function
Last Updated
3 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 13, 2019
End Date
March 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Saurabh Thosar

Principal Investigator

Oregon Health and Science University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Endothelial Function

Time Frame: 3 weeks

Investigators will measure endothelial function as flow-mediated dilation at baseline, and each hour of the 3-hour sitting trials.

Oxidative stress

Time Frame: 3 weeks

Oxidative stress will be measured using malondialdehyde adducts (MDA) from Ethylenediaminetetraacetic acid (EDTA) plasma.

Endothelin-1

Time Frame: 3 weeks

Endothelin 1 (ET-1) will be measured from Ethylenediaminetetraacetic acid (EDTA) plasma.

Heart rate

Time Frame: 3 weeks

During 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 pressure

Time Frame: 3 weeks

During the weekly trials, blood pressure will be measured as systolic over diastolic in a seated position in the dominant arm

24-hour BP measurement

Time Frame: 3 weeks

Investigators will measure 24-hour ambulatory blood pressure monitoring (AMBP, Spacelabs, Inc) at baseline and for 24-h before each in-lab visit.

Sleep duration

Time Frame: 3 weeks

Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.

Sleep efficiency

Time Frame: 3 weeks

Sleep efficiency will be scored from the ActiGraph and correlated with the sleep and activity diary.

Activity

Time Frame: 3 weeks

Activity will be scored from the ActiGraph and correlated with the sleep and activity diary.

Activity Perception

Time Frame: 3 weeks

Activity 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.

Study Sites (1)

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