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Sedentary Behavior, Cardiovascular Function, and Sleep (PACE)

3. august 2022 opdateret af: Saurabh Thosar, Oregon Health and Science University
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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

20

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Oregon
      • Portland, Oregon, Forenede Stater, 97239
        • Rekruttering
        • Oregon Institute of Occupational Health Sciences
        • Kontakt:
        • Ledende efterforsker:
          • Saurabh Thosar, Dr.

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

20 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Adfærdsmæssigt: Reduced Activity
Participants reduce their activity level to <5,000 steps/day and <50 % of baseline steps.
Andre navne:
  • Sedentary Behavior

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Endothelial Function
Tidsramme: 3 weeks
Investigators will measure endothelial function as flow-mediated dilation at baseline, and each hour of the 3-hour sitting trials.
3 weeks
Oxidative stress
Tidsramme: 3 weeks
Oxidative stress will be measured using malondialdehyde adducts (MDA) from Ethylenediaminetetraacetic acid (EDTA) plasma.
3 weeks
Endothelin-1
Tidsramme: 3 weeks
Endothelin 1 (ET-1) will be measured from Ethylenediaminetetraacetic acid (EDTA) plasma.
3 weeks
Heart rate
Tidsramme: 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.
3 weeks
Blood pressure
Tidsramme: 3 weeks
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
Tidsramme: 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.
3 weeks
Sleep duration
Tidsramme: 3 weeks
Sleep duration will be scored from the ActiGraph and correlated with the sleep and activity diary.
3 weeks
Sleep efficiency
Tidsramme: 3 weeks
Sleep efficiency will be scored from the ActiGraph and correlated with the sleep and activity diary.
3 weeks
Activity
Tidsramme: 3 weeks
Activity will be scored from the ActiGraph and correlated with the sleep and activity diary.
3 weeks
Activity Perception
Tidsramme: 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.
3 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Oregon Health and Science University

Efterforskere

  • Ledende efterforsker: Saurabh Thosar, Dr., Oregon Institute of Occupational Health Sciences

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

13. november 2019

Primær færdiggørelse (Forventet)

31. marts 2023

Studieafslutning (Forventet)

31. marts 2023

Datoer for studieregistrering

Først indsendt

15. oktober 2019

Først indsendt, der opfyldte QC-kriterier

21. oktober 2019

Først opslået (Faktiske)

23. oktober 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • STUDY00020458

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

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Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Søvn

Kliniske forsøg med Reduced Activity

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Betingelser

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Kosttilskud

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Placeringer

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