- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT04075279
Heart at Work Study
6. april 2021 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert 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).
Studietype
Observasjonsmessig
Registrering (Faktiske)
19
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Pennsylvania
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Pittsburgh, Pennsylvania, Forente stater, 15261
- Physical Activity and Weight Management Research Laboratory
-
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
35 år til 59 år (Voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Mann
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Crossover
- Tidsperspektiver: Tverrsnitt
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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.
|
24 hours
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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).
|
24 hours
|
Nocturnal Heart Rate Variability, RMSSD
Tidsramme: approximately 8 hours (sleep time)
|
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).
|
approximately 8 hours (sleep time)
|
Physical Activity Pattern. Steps Per Day
Tidsramme: 1 week
|
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
|
1 week
|
Nocturnal Heart Rate Variability, SDNN
Tidsramme: approximately 8 hours (sleep time)
|
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).
|
approximately 8 hours (sleep time)
|
Nocturnal Heart Rate Variability, LF
Tidsramme: approximately 8 hours (sleep time)
|
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).
|
approximately 8 hours (sleep time)
|
Nocturnal Heart Rate Variability, HF
Tidsramme: approximately 8 hours (sleep time)
|
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).
|
approximately 8 hours (sleep time)
|
Physical Activity Pattern. MVPA
Tidsramme: 1 week
|
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
|
Physical Activity Pattern. LPA
Tidsramme: 1 week
|
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
|
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
|
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
|
24-hour Ambulatory Diastolic Blood Pressure
Tidsramme: 24 hours
|
We will calculate the average diastolic blood pressure over a 24-hour period on two separate days (workdays versus non-workdays).
|
24 hours
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Tyler D Quinn, MS, graduate student
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
17. oktober 2019
Primær fullføring (Faktiske)
20. april 2020
Studiet fullført (Faktiske)
24. juli 2020
Datoer for studieregistrering
Først innsendt
28. august 2019
Først innsendt som oppfylte QC-kriteriene
29. august 2019
Først lagt ut (Faktiske)
30. august 2019
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
3. mai 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
6. april 2021
Sist bekreftet
1. april 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- STUDY19050097
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
IPD-planbeskrivelse
Upon completion of all data collection, data will be analyzed and summary conclusions will be published in a peer reviewed scientific journal.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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