Heart at Work Study

Cardiovascular Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04075279
• Other study ID #: STUDY19050097
• Status: Completed
• Start date: October 17, 2019
• Est. completion date: July 24, 2020

Study information

• Verified date: April 2021
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 24, 2020
• Est. primary completion date: April 20, 2020
• Gender: Male
• Age group: 35 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Cardiovascular Risk Factor
• Occupational Diseases
• Occupational Exposure

Locations

Country	Name	City	State
United States	Physical Activity and Weight Management Research Laboratory	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	24-hour Heart Rate	We will calculate the average heart rate over each 24 hour period throughout a one week monitoring period.	24 hours
Secondary	24-hour Ambulatory Systolic Blood Pressure	We will calculate the average systolic blood pressure over a 24-hour period on two separate days (workdays versus non-workdays).	24 hours
Secondary	Nocturnal Heart Rate Variability, RMSSD	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)
Secondary	Physical Activity Pattern. Steps Per Day	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
Secondary	Nocturnal Heart Rate Variability, SDNN	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)
Secondary	Nocturnal Heart Rate Variability, LF	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)
Secondary	Nocturnal Heart Rate Variability, HF	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)
Secondary	Physical Activity Pattern. MVPA	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
Secondary	Physical Activity Pattern. LPA	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
Secondary	Physical Activity Pattern. Sedentary	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
Secondary	Physical Activity Pattern. Upright	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
Secondary	24-hour Ambulatory Diastolic Blood Pressure	We will calculate the average diastolic blood pressure over a 24-hour period on two separate days (workdays versus non-workdays).	24 hours