Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT04137068

Conditions

Sedentary Behavior

Cardiovascular Function

Sleep

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

Interventions

Reduced Activity

Study Details

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.

Conditions

Sedentary Behavior

Cardiovascular Function

Sleep

Study ID

NCT04137068

Start date

Nov 13, 2019

Status verified date

Aug, 2022

Completion date

Mar 31, 2023

Anticipated

Primary completion date

Mar 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 20 - 70+

Healthy Volunteers: Accepted

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 Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

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.

Interventions

Reduced Activity

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

Primary outcome measure

  • Endothelial Function [ Time Frame: 3 weeks ]
  • Oxidative stress [ Time Frame: 3 weeks ]
  • Endothelin-1 [ Time Frame: 3 weeks ]
  • Heart rate [ Time Frame: 3 weeks ]
  • Blood pressure [ Time Frame: 3 weeks ]
  • 24-hour BP measurement [ Time Frame: 3 weeks ]
  • Sleep duration [ Time Frame: 3 weeks ]
  • Sleep efficiency [ Time Frame: 3 weeks ]
  • Activity [ Time Frame: 3 weeks ]
  • Activity Perception [ Time Frame: 3 weeks ]

Central Contacts and Locations

Locations

Oregon Institute of Occupational Health Sciences

Recruiting

Portland, Oregon, United States, 97239

Contacts

Saurabh Thosar, Dr.

503-494-2064thosar@ohsu.edu

Principal Investigator:

Saurabh Thosar, Dr.

More Information

Sponsor

Oregon Health and Science University

Last update posted

Aug 5, 2022

Last verified

Aug, 2022

Keywords

  • Physical Activity
  • Sleep
  • Sedentary
  • Cardiovascular

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2022-08-05.