Sedentary BehaviorPACENCT04137068
Sedentary Behavior, Cardiovascular Function, and Sleep
A study testing Reduced Activity in people with Sedentary Behavior and Cardiovascular Function, run by Oregon Health and Science University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Sedentary Behavior, Cardiovascular Function, Sleep
- What is being tested?
- Reduced Activity
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2019to 31 Mar 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Oregon Institute of Occupational Health Sciences
Portland, Oregon, 97239
Saurabh Thosar, Dr., 503-494-2064, thosar@ohsu.edu
Saurabh Thosar, Dr.
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Sedentary Behavior, Cardiovascular Function, Sleep
- Being tested
- Reduced Activity
- Keywords
- Physical Activity, Sleep, Sedentary, Cardiovascular
- Medical subject headings
- Sedentary Behavior, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Reduced ActivityBehavioural
Also called Sedentary Behavior
Participants reduce their activity level to <5,000 steps/day and <50 % of baseline steps.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Reduced Activity |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Investigators will measure endothelial function as flow-mediated dilation at baseline, and each hour of the 3-hour sitting trials.
Measured: 3 weeks
Oxidative stress
Oxidative stress will be measured using malondialdehyde adducts (MDA) from Ethylenediaminetetraacetic acid (EDTA) plasma.
Measured: 3 weeks
Endothelin-1
Endothelin 1 (ET-1) will be measured from Ethylenediaminetetraacetic acid (EDTA) plasma.
Measured: 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.
Measured: 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
Measured: 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.
Measured: 3 weeks
Sleep duration
Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.
Measured: 3 weeks
Sleep efficiency
Sleep efficiency will be scored from the ActiGraph and correlated with the sleep and activity diary.
Measured: 3 weeks
Activity
Activity will be scored from the ActiGraph and correlated with the sleep and activity diary.
Measured: 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.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start13 Nov 2019
- Primary completion31 Mar 2023 (estimated)
- Study completion31 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sedentary BehaviorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saurabh Thosar, Oregon Health and Science University
- Investigators
- Saurabh Thosar, Dr., Principal investigator, Oregon Institute of Occupational Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137068
- Sponsor's protocol ID
- STUDY00020458
- Acronym
- PACE
- Status last verified
- Aug 2022
- First submitted
- 15 Oct 2019
- Last updated
- 5 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedentary Behavior, Cardiovascular Function, and Sleep
- ClinicalTrials.gov ID
- NCT04137068
- Acronym / sponsor ID
- PACE / STUDY00020458
- Conditions
- Sedentary Behavior, Cardiovascular Function, Sleep
- Keywords
- Physical Activity, Sleep, Sedentary, Cardiovascular
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 13 Nov 2019 (actual)
- Primary completion
- 31 Mar 2023 (estimated)
- Study completion
- 31 Mar 2023 (estimated)
- First posted
- 23 Oct 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sedentary to Active | Other | Behavioral: Reduced ActivityParticipants 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. |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Reduced ActivityAlso: Sedentary BehaviorParticipants reduce their activity level to <5,000 steps/day and <50 % of baseline steps. | Behavioural | Sedentary to Active |
Primary outcome
Endothelial Function
Time frame: 3 weeks
Investigators will measure endothelial function as flow-mediated dilation at baseline, and each hour of the 3-hour sitting trials.
Oxidative stress
Time frame: 3 weeks
Oxidative stress will be measured using malondialdehyde adducts (MDA) from Ethylenediaminetetraacetic acid (EDTA) plasma.
Endothelin-1
Time frame: 3 weeks
Endothelin 1 (ET-1) will be measured from Ethylenediaminetetraacetic acid (EDTA) plasma.
Heart rate
Time frame: 3 weeks
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.
Blood pressure
Time frame: 3 weeks
During the weekly trials, blood pressure will be measured as systolic over diastolic in a seated position in the dominant arm
24-hour BP measurement
Time frame: 3 weeks
Investigators will measure 24-hour ambulatory blood pressure monitoring (AMBP, Spacelabs, Inc) at baseline and for 24-h before each in-lab visit.
Sleep duration
Time frame: 3 weeks
Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.
Sleep efficiency
Time frame: 3 weeks
Sleep efficiency will be scored from the ActiGraph and correlated with the sleep and activity diary.
Activity
Time frame: 3 weeks
Activity will be scored from the ActiGraph and correlated with the sleep and activity diary.
Activity Perception
Time frame: 3 weeks
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saurabh Thosar, Dr. principal investigator
Oregon Institute of Occupational Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Reduced Activity in people with Sedentary Behavior and Cardiovascular Function, run by Oregon Health and Science University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endothelial Function (time frame: 3 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2022.