Sedentary Behavior, Cardiovascular Function, and Sleep (PACE)

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.

Study Overview

• Status: Recruiting
• Conditions: Sleep; Sedentary Behavior; Cardiovascular Function
• Intervention / Treatment: Behavioral: Reduced Activity

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Oregon
    • Portland, Oregon, United States, 97239
      • Recruiting
      • Oregon Institute of Occupational Health Sciences
      • Contact: Saurabh Thosar, Dr.; Phone Number: 503-494-2064; Email: thosar@ohsu.edu
      • Principal Investigator: Saurabh Thosar, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Sedentary to Active; Participants will visit the research laboratory for baseline measurements at visit 1 after wearing a pedometer for one week and maintaining their typical level of physical activity. After the baseline visit, participants will reduce their step count by more than half for two weeks. Participants will visit the laboratory once every week during the 2 week interventional period for a total of 3 visits.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Endothelial Function	Investigators will measure endothelial function as flow-mediated dilation at baseline, and each hour of the 3-hour sitting trials.	3 weeks
Oxidative stress	Oxidative stress will be measured using malondialdehyde adducts (MDA) from Ethylenediaminetetraacetic acid (EDTA) plasma.	3 weeks
Endothelin-1	Endothelin 1 (ET-1) will be measured from Ethylenediaminetetraacetic acid (EDTA) plasma.	3 weeks
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
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
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
Sleep duration	Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.	3 weeks
Sleep efficiency	Sleep efficiency will be scored from the ActiGraph and correlated with the sleep and activity diary.	3 weeks
Activity	Activity will be scored from the ActiGraph and correlated with the sleep and activity diary.	3 weeks
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

Collaborators and Investigators

• Sponsor: Oregon Health and Science University
• Investigators: Principal Investigator: Saurabh Thosar, Dr., Oregon Institute of Occupational Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2019
• Primary Completion (Anticipated): March 31, 2023
• Study Completion (Anticipated): March 31, 2023

Study Registration Dates

• First Submitted: October 15, 2019
• First Submitted That Met QC Criteria: October 21, 2019
• First Posted (Actual): October 23, 2019

Study Record Updates

• Last Update Posted (Actual): August 5, 2022
• Last Update Submitted That Met QC Criteria: August 3, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Physical Activity; Sleep; Cardiovascular; Sedentary
• Other Study ID Numbers: STUDY00020458

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No