Clinical trial NCT04137068: Sedentary Behavior, Cardiovascular Function, and Sleep
Official title: Sedentary Behavior, Cardiovascular Function, and Sleep
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Sedentary Behavior
Cardiovascular Function
Sleep
Keywords: Physical Activity
Sleep
Sedentary
Cardiovascular
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2019-10-23
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: Endothelial Function
timeFrame: 3 weeks
measure: Oxidative stress
timeFrame: 3 weeks
measure: Endothelin-1
timeFrame: 3 weeks
measure: Heart rate
timeFrame: 3 weeks
measure: Blood pressure
timeFrame: 3 weeks
measure: 24-hour BP measurement
timeFrame: 3 weeks
measure: Sleep duration
timeFrame: 3 weeks
measure: Sleep efficiency
timeFrame: 3 weeks
measure: Activity
timeFrame: 3 weeks
measure: Activity Perception
timeFrame: 3 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Institute of Occupational Health Sciences
state: Oregon
Study officials:
affiliation: Oregon Institute of Occupational Health Sciences
name: Saurabh Thosar, Dr.
role: PRINCIPAL_INVESTIGATOR
References: