Sedentary Behavior, Cardiovascular Function, and Sleep

Sleep Clinical Trial

— PACE  

Official title:

Sedentary Behavior, Cardiovascular Function, and Sleep

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04137068
• Other study ID #: STUDY00020458
• Status: Recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Cardiovascular Function
• Sedentary Behavior
• Sleep

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