Heart at Work Study

• Sponsor: University of Pittsburgh (Other)
• Overall Status: Completed
• CT.gov ID: NCT04075279
• Collaborator: (none)
• Enrollment: 19
• Location: 1
• Actual Duration (Months): 9.2
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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	Intervention/Treatment	Phase
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

• 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: Oct 17, 2019
• Actual Primary Completion Date: Apr 20, 2020
• Actual Study Completion Date: Jul 24, 2020

Outcome Measures

Primary Outcome Measures

1. 24-hour Heart Rate [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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 [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

Criteria

• Ages Eligible for Study: 35 Years to 59 Years
• Sexes Eligible for Study: Male

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

Locations

	Site	City	State	Country	Postal Code
1	Physical Activity and Weight Management Research Laboratory	Pittsburgh	Pennsylvania	United States	15261

Sponsors and Collaborators

• University of Pittsburgh

Investigators

• Principal Investigator: Tyler D Quinn, MS, Graduate Student

Study Documents (Full-Text)

• Study Protocol, Statistical Analysis Plan, and Informed Consent Form - Sep 26, 2019

More Information

Publications

None provided.

• Responsible Party: Tyler Quinn, Principle Investigator, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04075279
• Other Study ID Numbers: STUDY19050097
• First Posted: Aug 30, 2019
• Last Update Posted: May 3, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Cardiovascular Diseases; Occupational Diseases

Study Results

Participant Flow

Arm/Group Title	Middle-aged Males in High Activity Occupations
Arm/Group Description	All participants were enrolled into a single arm and all comparisons were made within subjects.
Period Title: Overall Study
STARTED	19
COMPLETED	19
NOT COMPLETED	0

Baseline Characteristics

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Overall Participants	19
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	46.6 (7.9)
Sex: Female, Male (Count of Participants)
Female	0 0%
Male	19 100%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	0 0%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	4 21.1%
White	13 68.4%
More than one race	2 10.5%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	19 100%
Occupational Industry (Count of Participants)
Food Service	8 42.1%
Material Moving	9 47.4%
Healthcare	1 5.3%
Building and Grounds Maintenance	1 5.3%

Outcome Measures

1. Primary Outcome

Title	24-hour Heart Rate
Description	We will calculate the average heart rate over each 24 hour period throughout a one week monitoring period.
Time Frame	24 hours

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
Workdays	83.8 (1.2)
Non-workdays	78.5 (1.4)

2. Secondary Outcome

Title	24-hour Ambulatory Systolic Blood Pressure
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
Workdays	126.0 (1.7)
Non-workdays	124.0 (1.8)

3. Secondary Outcome

Title	Nocturnal Heart Rate Variability, RMSSD
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
workdays	34.17 (4.04)
non-workdays	35.34 (4.32)

4. Secondary Outcome

Title	Physical Activity Pattern. Steps Per Day
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
Workdays	12,772 (945)
Non-workdays	7,923 (1,063)

5. Secondary Outcome

Title	Nocturnal Heart Rate Variability, SDNN
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
workdays	39.85 (3.48)
non-workdays	42.14 (3.71)

6. Secondary Outcome

Title	Nocturnal Heart Rate Variability, LF
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
workdays	6.18 (0.20)
non-workdays	6.45 (0.21)

7. Secondary Outcome

Title	Nocturnal Heart Rate Variability, HF
Description	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)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
workdays	5.22 (0.30)
non-workdays	5.56 (0.31)

8. Secondary Outcome

Title	Physical Activity Pattern. MVPA
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
Workdays	72.4 (7.2)
Non-workdays	41.5 (8.9)

9. Secondary Outcome

Title	Physical Activity Pattern. LPA
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
Workdays	391.5 (19.9)
Non-workdays	285.2 (23.3)

10. Secondary Outcome

Title	Physical Activity Pattern. Sedentary
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
Workdays	492.5 (18.4)
Non-workdays	629.7 (22.5)

11. Secondary Outcome

Title	Physical Activity Pattern. Upright
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
Workdays	462.4 (18.4)
Non-workdays	325.2 (22.5)

12. Secondary Outcome

Title	24-hour Ambulatory Diastolic Blood Pressure
Description	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

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
Measure Participants	19
Workdays	75.2 (1.0)
Non-workdays	72.6 (1.1)

Adverse Events

Time Frame	1 week
Arm/Group Title	Research Study Participation
Arm/Group Description	Participants who were enrolled in the study and completed all study procedures.
All Cause Mortality
	Research Study Participation
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Serious Adverse Events
	Research Study Participation
	Affected / at Risk (%)	# Events
Total	0/19 (0%)
Other (Not Including Serious) Adverse Events
	Research Study Participation
	Affected / at Risk (%)	# Events
Total	0/19 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.