Sedentary Behavior, Cardiovascular Function, and Sleep
PACE
1 other identifier
interventional
20
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 15, 2019
CompletedFirst Posted
Study publicly available on registry
October 23, 2019
CompletedStudy Start
First participant enrolled
November 13, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedAugust 5, 2022
August 1, 2022
3.4 years
October 15, 2019
August 3, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
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
Study Arms (1)
Sedentary to Active
OTHERParticipants 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.
Interventions
Participants reduce their activity level to \<5,000 steps/day and \<50 % of baseline steps.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Oregon Institute of Occupational Health Sciences
Portland, Oregon, 97239, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Saurabh Thosar, Dr.
Oregon Institute of Occupational Health Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
October 15, 2019
First Posted
October 23, 2019
Study Start
November 13, 2019
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
August 5, 2022
Record last verified: 2022-08
Data Sharing
- IPD Sharing
- Will not share