Sedentary Behavior, Cardiovascular Function, and Sleep

NCT ID: NCT04137068

Last Updated: 2022-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-13

Study Completion Date

2023-03-31

Brief Summary

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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

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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.

Conditions

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Sedentary Behavior Cardiovascular Function Sleep

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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.

Group Type OTHER

Reduced Activity

Intervention Type BEHAVIORAL

Participants reduce their activity level to \<5,000 steps/day and \<50 % of baseline steps.

Interventions

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Reduced Activity

Participants reduce their activity level to \<5,000 steps/day and \<50 % of baseline steps.

Intervention Type BEHAVIORAL

Other Intervention Names

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Sedentary Behavior

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Saurabh Thosar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Saurabh Thosar, Dr.

Role: PRINCIPAL_INVESTIGATOR

Oregon Institute of Occupational Health Sciences

Locations

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Oregon Institute of Occupational Health Sciences

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Facility Contacts

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Saurabh Thosar, Dr.

Role: primary

503-494-2064

Other Identifiers

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STUDY00020458

Identifier Type: -

Identifier Source: org_study_id

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