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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04137068
Other study ID # STUDY00020458
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date November 13, 2019
Est. completion date March 31, 2023

Study information

Verified date August 2022
Source Oregon Health and Science University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date March 31, 2023
Est. primary completion date March 31, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 80 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Reduced Activity
Participants reduce their activity level to <5,000 steps/day and <50 % of baseline steps.

Locations

Country Name City State
United States Oregon Institute of Occupational Health Sciences Portland Oregon

Sponsors (1)

Lead Sponsor Collaborator
Oregon Health and Science University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Endothelial Function Investigators will measure endothelial function as flow-mediated dilation at baseline, and each hour of the 3-hour sitting trials. 3 weeks
Primary Oxidative stress Oxidative stress will be measured using malondialdehyde adducts (MDA) from Ethylenediaminetetraacetic acid (EDTA) plasma. 3 weeks
Primary Endothelin-1 Endothelin 1 (ET-1) will be measured from Ethylenediaminetetraacetic acid (EDTA) plasma. 3 weeks
Primary Heart rate 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. 3 weeks
Primary Blood pressure During the weekly trials, blood pressure will be measured as systolic over diastolic in a seated position in the dominant arm 3 weeks
Primary 24-hour BP measurement Investigators will measure 24-hour ambulatory blood pressure monitoring (AMBP, Spacelabs, Inc) at baseline and for 24-h before each in-lab visit. 3 weeks
Primary Sleep duration Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary. 3 weeks
Primary Sleep efficiency Sleep efficiency will be scored from the ActiGraph and correlated with the sleep and activity diary. 3 weeks
Primary Activity Activity will be scored from the ActiGraph and correlated with the sleep and activity diary. 3 weeks
Primary Activity Perception 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. 3 weeks
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