- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT04075279
Heart at Work Study
6 april 2021 uppdaterad 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.
Studieöversikt
Status
Avslutad
Detaljerad beskrivning
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).
Studietyp
Observationell
Inskrivning (Faktisk)
19
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15261
- Physical Activity and Weight Management Research Laboratory
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
35 år till 59 år (Vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Manlig
Testmetod
Icke-sannolikhetsprov
Studera befolkning
Middle-aged male food service workers
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Crossover
- Tidsperspektiv: Tvärsnitt
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
24-hour Heart Rate
Tidsram: 24 hours
|
We will calculate the average heart rate over each 24 hour period throughout a one week monitoring period.
|
24 hours
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
24-hour Ambulatory Systolic Blood Pressure
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
1 week
|
Physical Activity Pattern. LPA
Tidsram: 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
|
1 week
|
Physical Activity Pattern. Sedentary
Tidsram: 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
|
1 week
|
Physical Activity Pattern. Upright
Tidsram: 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
|
1 week
|
24-hour Ambulatory Diastolic Blood Pressure
Tidsram: 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
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Tyler D Quinn, MS, graduate student
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
17 oktober 2019
Primärt slutförande (Faktisk)
20 april 2020
Avslutad studie (Faktisk)
24 juli 2020
Studieregistreringsdatum
Först inskickad
28 augusti 2019
Först inskickad som uppfyllde QC-kriterierna
29 augusti 2019
Första postat (Faktisk)
30 augusti 2019
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
3 maj 2021
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
6 april 2021
Senast verifierad
1 april 2021
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- STUDY19050097
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
Nej
IPD-planbeskrivning
Upon completion of all data collection, data will be analyzed and summary conclusions will be published in a peer reviewed scientific journal.
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
Studerar en amerikansk FDA-reglerad produktprodukt
Nej
produkt tillverkad i och exporterad från U.S.A.
Nej
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