Trial Outcomes & Findings for Heart at Work Study (NCT NCT04075279)

NCT ID: NCT04075279

Last Updated: 2021-05-03

Results Overview

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

• Recruitment status: COMPLETED
• Target enrollment: 19 participants
• Primary outcome timeframe: 24 hours
• Results posted on: 2021-05-03

Participant Flow

Participant milestones

Measure	Middle-aged Males in High Activity Occupations All participants were enrolled into a single arm and all comparisons were made within subjects.
Overall Study STARTED	19
Overall Study COMPLETED	19
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Heart at Work Study

Baseline characteristics by cohort

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
Age, Continuous	46.6 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	19 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	4 Participants n=5 Participants
Race (NIH/OMB) White	13 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	19 participants n=5 Participants
Occupational Industry Food Service	8 Participants n=5 Participants
Occupational Industry Material Moving	9 Participants n=5 Participants
Occupational Industry Healthcare	1 Participants n=5 Participants
Occupational Industry Building and Grounds Maintenance	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 24 hours

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

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
24-hour Heart Rate Workdays	83.8 beats per minute Standard Error 1.2
24-hour Heart Rate Non-workdays	78.5 beats per minute Standard Error 1.4

SECONDARY outcome

Timeframe: 24 hours

We will calculate the average systolic blood pressure over a 24-hour period on two separate days (workdays versus non-workdays).

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
24-hour Ambulatory Systolic Blood Pressure Workdays	126.0 millimeters of Mercury Standard Error 1.7
24-hour Ambulatory Systolic Blood Pressure Non-workdays	124.0 millimeters of Mercury Standard Error 1.8

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
Nocturnal Heart Rate Variability, RMSSD workdays	34.17 milliseconds Standard Error 4.04
Nocturnal Heart Rate Variability, RMSSD non-workdays	35.34 milliseconds Standard Error 4.32

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
Physical Activity Pattern. Steps Per Day Workdays	12,772 steps per day Standard Error 945
Physical Activity Pattern. Steps Per Day Non-workdays	7,923 steps per day Standard Error 1,063

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
Nocturnal Heart Rate Variability, SDNN workdays	39.85 milliseconds Standard Error 3.48
Nocturnal Heart Rate Variability, SDNN non-workdays	42.14 milliseconds Standard Error 3.71

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
Nocturnal Heart Rate Variability, LF workdays	6.18 log milliseconds Standard Error 0.20
Nocturnal Heart Rate Variability, LF non-workdays	6.45 log milliseconds Standard Error 0.21

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
Nocturnal Heart Rate Variability, HF workdays	5.22 log milliseconds Standard Error 0.30
Nocturnal Heart Rate Variability, HF non-workdays	5.56 log milliseconds Standard Error 0.31

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
Physical Activity Pattern. MVPA Workdays	72.4 minutes per day Standard Error 7.2
Physical Activity Pattern. MVPA Non-workdays	41.5 minutes per day Standard Error 8.9

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
Physical Activity Pattern. LPA Workdays	391.5 minutes per day Standard Error 19.9
Physical Activity Pattern. LPA Non-workdays	285.2 minutes per day Standard Error 23.3

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
Physical Activity Pattern. Sedentary Workdays	492.5 minutes per day Standard Error 18.4
Physical Activity Pattern. Sedentary Non-workdays	629.7 minutes per day Standard Error 22.5

SECONDARY outcome

Timeframe: 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

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
Physical Activity Pattern. Upright Workdays	462.4 minutes per day Standard Error 18.4
Physical Activity Pattern. Upright Non-workdays	325.2 minutes per day Standard Error 22.5

SECONDARY outcome

Timeframe: 24 hours

We will calculate the average diastolic blood pressure over a 24-hour period on two separate days (workdays versus non-workdays).

Outcome measures

Measure	Research Study Participation n=19 Participants Participants who were enrolled in the study and completed all study procedures.
24-hour Ambulatory Diastolic Blood Pressure Workdays	75.2 millimeters of Mercury Standard Error 1.0
24-hour Ambulatory Diastolic Blood Pressure Non-workdays	72.6 millimeters of Mercury Standard Error 1.1

Adverse Events

Research Study Participation

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Tyler Quinn

Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health

Phone: 412-386-4450

Email: yhh7@cdc.gov

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place