- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT04137068
Sedentary Behavior, Cardiovascular Function, and Sleep (PACE)
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Oregon
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Portland, Oregon, Verenigde Staten, 97239
- Werving
- Oregon Institute of Occupational Health Sciences
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Contact:
- Saurabh Thosar, Dr.
- Telefoonnummer: 503-494-2064
- E-mail: thosar@ohsu.edu
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Hoofdonderzoeker:
- Saurabh Thosar, Dr.
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Ander
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Ander: 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.
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Participants reduce their activity level to <5,000 steps/day and <50 % of baseline steps.
Andere namen:
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Endothelial Function
Tijdsspanne: 3 weeks
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Investigators will measure endothelial function as flow-mediated dilation at baseline, and each hour of the 3-hour sitting trials.
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3 weeks
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Oxidative stress
Tijdsspanne: 3 weeks
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Oxidative stress will be measured using malondialdehyde adducts (MDA) from Ethylenediaminetetraacetic acid (EDTA) plasma.
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3 weeks
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Endothelin-1
Tijdsspanne: 3 weeks
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Endothelin 1 (ET-1) will be measured from Ethylenediaminetetraacetic acid (EDTA) plasma.
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3 weeks
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Heart rate
Tijdsspanne: 3 weeks
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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.
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3 weeks
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Blood pressure
Tijdsspanne: 3 weeks
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During the weekly trials, blood pressure will be measured as systolic over diastolic in a seated position in the dominant arm
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3 weeks
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24-hour BP measurement
Tijdsspanne: 3 weeks
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Investigators will measure 24-hour ambulatory blood pressure monitoring (AMBP, Spacelabs, Inc) at baseline and for 24-h before each in-lab visit.
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3 weeks
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Sleep duration
Tijdsspanne: 3 weeks
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Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.
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3 weeks
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Sleep efficiency
Tijdsspanne: 3 weeks
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Sleep efficiency will be scored from the ActiGraph and correlated with the sleep and activity diary.
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3 weeks
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Activity
Tijdsspanne: 3 weeks
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Activity will be scored from the ActiGraph and correlated with the sleep and activity diary.
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3 weeks
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Activity Perception
Tijdsspanne: 3 weeks
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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.
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3 weeks
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Saurabh Thosar, Dr., Oregon Institute of Occupational Health Sciences
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- STUDY00020458
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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