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Heart at Work Study

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04075279
Enrollment
19
Registered
2019-08-30
Start date
2019-10-17
Completion date
2020-07-24
Last updated
2021-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiovascular Diseases, Cardiovascular Risk Factor, Occupational Diseases, Occupational Exposure

Brief summary

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

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).

Interventions

None listed

Sponsors

University of Pittsburgh
Lead SponsorOTHER

Study design

Observational model
CASE_CROSSOVER
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
MALE
Age
35 Years to 59 Years

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.

Design outcomes

Primary

MeasureTime frameDescription
24-hour Heart Rate24 hoursWe will calculate the average heart rate over each 24 hour period throughout a one week monitoring period.

Secondary

MeasureTime frameDescription
24-hour Ambulatory Systolic Blood Pressure24 hoursWe will calculate the average systolic blood pressure over a 24-hour period on two separate days (workdays versus non-workdays).
Nocturnal Heart Rate Variability, RMSSDapproximately 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).
Physical Activity Pattern. Steps Per Day1 weekThis 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
Nocturnal Heart Rate Variability, SDNNapproximately 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).
Nocturnal Heart Rate Variability, LFapproximately 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).
Nocturnal Heart Rate Variability, HFapproximately 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).
Physical Activity Pattern. MVPA1 weekThis 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
Physical Activity Pattern. LPA1 weekThis 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
Physical Activity Pattern. Sedentary1 weekThis physical activity metric of minutes of sedentary time was calculated as average minutes during each day type (work versus non-workdays) throughout one week
Physical Activity Pattern. Upright1 weekThis physical activity metric of minutes of upright time was calculated as average minutes during each day type (work versus non-workdays) throughout one week
24-hour Ambulatory Diastolic Blood Pressure24 hoursWe will calculate the average diastolic blood pressure over a 24-hour period on two separate days (workdays versus non-workdays).

Countries

United States

Participant flow

Participants by arm

ArmCount
Research Study Participation
Participants who were enrolled in the study and completed all study procedures.
19
Total19

Baseline characteristics

CharacteristicResearch Study Participation
Age, Continuous46.6 years
STANDARD_DEVIATION 7.9
Occupational Industry
Building and Grounds Maintenance
1 Participants
Occupational Industry
Food Service
8 Participants
Occupational Industry
Healthcare
1 Participants
Occupational Industry
Material Moving
9 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
4 Participants
Race (NIH/OMB)
More than one race
2 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
White
13 Participants
Region of Enrollment
United States
19 participants
Sex: Female, Male
Female
0 Participants
Sex: Female, Male
Male
19 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 19
other
Total, other adverse events
0 / 19
serious
Total, serious adverse events
0 / 19

Outcome results

Primary

24-hour Heart Rate

We will calculate the average heart rate over each 24 hour period throughout a one week monitoring period.

Time frame: 24 hours

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study Participation24-hour Heart RateWorkdays83.8 beats per minuteStandard Error 1.2
Research Study Participation24-hour Heart RateNon-workdays78.5 beats per minuteStandard Error 1.4
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).

Time frame: 24 hours

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study Participation24-hour Ambulatory Diastolic Blood PressureWorkdays75.2 millimeters of MercuryStandard Error 1
Research Study Participation24-hour Ambulatory Diastolic Blood PressureNon-workdays72.6 millimeters of MercuryStandard Error 1.1
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).

Time frame: 24 hours

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study Participation24-hour Ambulatory Systolic Blood PressureWorkdays126.0 millimeters of MercuryStandard Error 1.7
Research Study Participation24-hour Ambulatory Systolic Blood PressureNon-workdays124.0 millimeters of MercuryStandard Error 1.8
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).

Time frame: approximately 8 hours (sleep time)

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study ParticipationNocturnal Heart Rate Variability, HFnon-workdays5.56 log millisecondsStandard Error 0.31
Research Study ParticipationNocturnal Heart Rate Variability, HFworkdays5.22 log millisecondsStandard Error 0.3
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).

Time frame: approximately 8 hours (sleep time)

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study ParticipationNocturnal Heart Rate Variability, LFworkdays6.18 log millisecondsStandard Error 0.2
Research Study ParticipationNocturnal Heart Rate Variability, LFnon-workdays6.45 log millisecondsStandard Error 0.21
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).

Time frame: approximately 8 hours (sleep time)

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study ParticipationNocturnal Heart Rate Variability, RMSSDworkdays34.17 millisecondsStandard Error 4.04
Research Study ParticipationNocturnal Heart Rate Variability, RMSSDnon-workdays35.34 millisecondsStandard Error 4.32
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).

Time frame: approximately 8 hours (sleep time)

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study ParticipationNocturnal Heart Rate Variability, SDNNworkdays39.85 millisecondsStandard Error 3.48
Research Study ParticipationNocturnal Heart Rate Variability, SDNNnon-workdays42.14 millisecondsStandard Error 3.71
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

Time frame: 1 week

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study ParticipationPhysical Activity Pattern. LPAWorkdays391.5 minutes per dayStandard Error 19.9
Research Study ParticipationPhysical Activity Pattern. LPANon-workdays285.2 minutes per dayStandard Error 23.3
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

Time frame: 1 week

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study ParticipationPhysical Activity Pattern. MVPAWorkdays72.4 minutes per dayStandard Error 7.2
Research Study ParticipationPhysical Activity Pattern. MVPANon-workdays41.5 minutes per dayStandard Error 8.9
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

Time frame: 1 week

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study ParticipationPhysical Activity Pattern. SedentaryWorkdays492.5 minutes per dayStandard Error 18.4
Research Study ParticipationPhysical Activity Pattern. SedentaryNon-workdays629.7 minutes per dayStandard Error 22.5
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

Time frame: 1 week

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study ParticipationPhysical Activity Pattern. Steps Per DayWorkdays12,772 steps per dayStandard Error 945
Research Study ParticipationPhysical Activity Pattern. Steps Per DayNon-workdays7,923 steps per day
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

Time frame: 1 week

ArmMeasureGroupValue (LEAST_SQUARES_MEAN)Dispersion
Research Study ParticipationPhysical Activity Pattern. UprightWorkdays462.4 minutes per dayStandard Error 18.4
Research Study ParticipationPhysical Activity Pattern. UprightNon-workdays325.2 minutes per dayStandard Error 22.5

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026