NCT04137068

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2019

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 15, 2019

Completed
8 days until next milestone

First Posted

Study publicly available on registry

October 23, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

November 13, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2023

Completed
Last Updated

August 5, 2022

Status Verified

August 1, 2022

Enrollment Period

3.4 years

First QC Date

October 15, 2019

Last Update Submit

August 3, 2022

Conditions

Keywords

Physical ActivitySleepSedentaryCardiovascular

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

OTHER

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

Interventions

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

Also known as: Sedentary Behavior
Sedentary to Active

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

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

RECRUITING

MeSH Terms

Conditions

Sedentary BehaviorMotor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

  • Saurabh Thosar, Dr.

    Oregon Institute of Occupational Health Sciences

    PRINCIPAL INVESTIGATOR

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

Locations