Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Heart at Work Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04075279
Recruitment Status : Completed
First Posted : August 30, 2019
Results First Posted : May 3, 2021
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Tyler Quinn, University of Pittsburgh

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
This is an observational study to examine the cardiovascular mechanisms of increased cardiovascular mortality in those with high activity occupations.

Condition or disease
Occupational Diseases Cardiovascular Diseases Cardiovascular Risk Factor Occupational Exposure

Detailed Description:
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).
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 19 participants
Observational Model: Case-Crossover
Time Perspective: Cross-Sectional
Official Title: Cardiovascular Mechanisms of the Occupational Physical Activity Health Paradox: 24-hour Physical Activity, Blood Pressure, and Heart Rate
Actual Study Start Date : October 17, 2019
Actual Primary Completion Date : April 20, 2020
Actual Study Completion Date : July 24, 2020
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 24-hour Heart Rate [ Time Frame: 24 hours ]
    We will calculate the average heart rate over each 24 hour period throughout a one week monitoring period.


Secondary Outcome Measures :
  1. 24-hour Ambulatory Systolic Blood Pressure [ Time Frame: 24 hours ]
    We will calculate the average systolic blood pressure over a 24-hour period on two separate days (workdays versus non-workdays).

  2. Nocturnal Heart Rate Variability, RMSSD [ Time Frame: 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).

  3. Physical Activity Pattern. Steps Per Day [ Time Frame: 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

  4. Nocturnal Heart Rate Variability, SDNN [ Time Frame: 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).

  5. Nocturnal Heart Rate Variability, LF [ Time Frame: 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).

  6. Nocturnal Heart Rate Variability, HF [ Time Frame: 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).

  7. Physical Activity Pattern. MVPA [ Time Frame: 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

  8. Physical Activity Pattern. LPA [ Time Frame: 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

  9. Physical Activity Pattern. Sedentary [ Time Frame: 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

  10. Physical Activity Pattern. Upright [ Time Frame: 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

  11. 24-hour Ambulatory Diastolic Blood Pressure [ Time Frame: 24 hours ]
    We will calculate the average diastolic blood pressure over a 24-hour period on two separate days (workdays versus non-workdays).


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Only males are eligible for this study.
Sampling Method:   Non-Probability Sample
Study Population
Middle-aged male food service workers
Criteria

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.
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04075279


Locations
Layout table for location information
United States, Pennsylvania
Physical Activity and Weight Management Research Laboratory
Pittsburgh, Pennsylvania, United States, 15261
Sponsors and Collaborators
University of Pittsburgh
Investigators
Layout table for investigator information
Principal Investigator: Tyler D Quinn, MS Graduate Student
  Study Documents (Full-Text)

Documents provided by Tyler Quinn, University of Pittsburgh:
Study Protocol, Statistical Analysis Plan, and Informed Consent Form  [PDF] September 26, 2019

More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Tyler Quinn, Principle Investigator, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT04075279    
Other Study ID Numbers: STUDY19050097
First Posted: August 30, 2019    Key Record Dates
Results First Posted: May 3, 2021
Last Update Posted: May 3, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Upon completion of all data collection, data will be analyzed and summary conclusions will be published in a peer reviewed scientific journal.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Cardiovascular Diseases
Occupational Diseases