- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT04075279
Heart at Work Study
6. april 2021 opdateret af: Tyler Quinn, University of Pittsburgh
Cardiovascular Mechanisms of the Occupational Physical Activity Health Paradox: 24-hour Physical Activity, Blood Pressure, and Heart Rate
This is an observational study to examine the cardiovascular mechanisms of increased cardiovascular mortality in those with high activity occupations.
Studieoversigt
Status
Afsluttet
Detaljeret beskrivelse
The current proposal uses a repeated-measures, within-subject design to address our aims.
Twenty male participants will report to the laboratory to provide informed consent, complete baseline assessments, and receive ambulatory monitors.
Following this session, each participant will wear physical activity and ambulatory cardiovascular monitors for 7 days, including at least one non-work day and one work day.
Characterization of work activity will use physical activity data from self-reported time at work (Specific Aim I).
The 24-hour cardiovascular load (HR and BP) and nocturnal HRV will be compared across work and non-work days (Specific Aim II).
Lastly, whether fitness level or job strain modify the difference in cardiovascular strain between work vs. non-work days will be evaluated (Specific Aim III).
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
19
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15261
- Physical Activity and Weight Management Research Laboratory
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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
35 år til 59 år (Voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Han
Prøveudtagningsmetode
Ikke-sandsynlighedsprøve
Studiebefolkning
Middle-aged male food service workers
Beskrivelse
Inclusion Criteria:
- middle age (35-59 years)
- male
- self-report working full-time in the food service industry (≥30 hours/week)
- self-report predominantly completing light intensity activity job responsibilities (≥75% work time walking, light movement, or standing)
Exclusion Criteria:
- Resting blood pressure of ≥150 mmHg systolic and/or ≥95 mmHg diastolic
- currently taking medications that are known to affect blood pressure or heart rate (e.g. Beta-blockers, ACE inhibitors, etc.)
- greater than low risk to participate in physical activity as determined by PAR-Q (answer of yes to any of the 7 physical activity readiness questionnaire questions)
- report working a second job in addition to their primary full-time job
- report working overnight shifts (10pm-6am)
- reported physical dysfunction (inability to walk 2 city blocks or climb 2 flights of stairs)
- inability to complete the sub-maximal exercise test to completion (80% age-predicted heart rate maximum)
- Currently being treated for a serious medical condition such as kidney disease, liver disease, cancer, or heart disease.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Observationsmodeller: Case-Crossover
- Tidsperspektiver: Tværsnit
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
24-hour Heart Rate
Tidsramme: 24 hours
|
We will calculate the average heart rate over each 24 hour period throughout a one week monitoring period.
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24 hours
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
24-hour Ambulatory Systolic Blood Pressure
Tidsramme: 24 hours
|
We will calculate the average systolic blood pressure over a 24-hour period on two separate days (workdays versus non-workdays).
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24 hours
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Nocturnal Heart Rate Variability, RMSSD
Tidsramme: approximately 8 hours (sleep time)
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We will calculate the average heart rate variability during each night's sleep for a total of one week.
The specific HRV variable presented is root mean square successive differences (RMSSD).
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approximately 8 hours (sleep time)
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Physical Activity Pattern. Steps Per Day
Tidsramme: 1 week
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This physical activity metric of steps per day was calculated as average number of steps during each day type (work versus non-workdays) throughout one week
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1 week
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Nocturnal Heart Rate Variability, SDNN
Tidsramme: approximately 8 hours (sleep time)
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We will calculate the average heart rate variability during each night's sleep for a total of one week.
The specific HRV variable presented is standard deviation of the normal to normal RR intervals (SDNN).
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approximately 8 hours (sleep time)
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Nocturnal Heart Rate Variability, LF
Tidsramme: approximately 8 hours (sleep time)
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We will calculate the average heart rate variability during each night's sleep for a total of one week.
The specific HRV variable presented is low frequency power (LF).
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approximately 8 hours (sleep time)
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Nocturnal Heart Rate Variability, HF
Tidsramme: approximately 8 hours (sleep time)
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We will calculate the average heart rate variability during each night's sleep for a total of one week.
The specific HRV variable presented is high frequency power (HF).
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approximately 8 hours (sleep time)
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Physical Activity Pattern. MVPA
Tidsramme: 1 week
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This physical activity metric of minutes of moderate to vigorous physical activity was calculated as average minutes during each day type (work versus non-workdays) throughout one week
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1 week
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Physical Activity Pattern. LPA
Tidsramme: 1 week
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This physical activity metric of minutes of light physical activity was calculated as average minutes during each day type (work versus non-workdays) throughout one week
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1 week
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Physical Activity Pattern. Sedentary
Tidsramme: 1 week
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This physical activity metric of minutes of sedentary time was calculated as average minutes during each day type (work versus non-workdays) throughout one week
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1 week
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Physical Activity Pattern. Upright
Tidsramme: 1 week
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This physical activity metric of minutes of upright time was calculated as average minutes during each day type (work versus non-workdays) throughout one week
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1 week
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24-hour Ambulatory Diastolic Blood Pressure
Tidsramme: 24 hours
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We will calculate the average diastolic blood pressure over a 24-hour period on two separate days (workdays versus non-workdays).
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24 hours
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Ledende efterforsker: Tyler D Quinn, MS, graduate student
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)
17. oktober 2019
Primær færdiggørelse (Faktiske)
20. april 2020
Studieafslutning (Faktiske)
24. juli 2020
Datoer for studieregistrering
Først indsendt
28. august 2019
Først indsendt, der opfyldte QC-kriterier
29. august 2019
Først opslået (Faktiske)
30. august 2019
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
3. maj 2021
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
6. april 2021
Sidst verificeret
1. april 2021
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- STUDY19050097
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Ingen
IPD-planbeskrivelse
Upon completion of all data collection, data will be analyzed and summary conclusions will be published in a peer reviewed scientific journal.
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Kliniske forsøg med Hjerte-kar-sygdomme
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