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OpenTrials
Completed

NCT Number: NCT04075279

Heart at Work Study

This is an observational study to examine the cardiovascular mechanisms of increased cardiovascular mortality in those with high activity occupations.

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Key information

Age range

35 year–59 year

Sex eligibility

Male

Study type

Observational

Primary location

Physical Activity and Weight Management Research Laboratory

Pittsburgh, Pennsylvania, 15261, United States

About this study

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).

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Registry information

Official study title

Cardiovascular Mechanisms of the Occupational Physical Activity Health Paradox: 24-hour Physical Activity, Blood Pressure, and Heart Rate

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Aug 30, 2019
Registry last updated
May 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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