- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04075279
Heart at Work Study
April 6, 2021 updated by: Tyler Quinn, University of Pittsburgh
Cardiovascular Mechanisms of the Occupational Physical Activity Health Paradox: 24-hour Physical Activity, Blood Pressure, and Heart Rate
This is an observational study to examine the cardiovascular mechanisms of increased cardiovascular mortality in those with high activity occupations.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
19
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15261
- Physical Activity and Weight Management Research Laboratory
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
35 years to 59 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Middle-aged male food service workers
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Crossover
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
24 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
|
24 hours
|
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).
|
approximately 8 hours (sleep time)
|
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
|
1 week
|
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).
|
approximately 8 hours (sleep time)
|
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).
|
approximately 8 hours (sleep time)
|
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).
|
approximately 8 hours (sleep time)
|
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
|
1 week
|
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
|
1 week
|
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
|
1 week
|
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
|
1 week
|
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).
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tyler D Quinn, MS, graduate student
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 17, 2019
Primary Completion (Actual)
April 20, 2020
Study Completion (Actual)
July 24, 2020
Study Registration Dates
First Submitted
August 28, 2019
First Submitted That Met QC Criteria
August 29, 2019
First Posted (Actual)
August 30, 2019
Study Record Updates
Last Update Posted (Actual)
May 3, 2021
Last Update Submitted That Met QC Criteria
April 6, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY19050097
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
Upon completion of all data collection, data will be analyzed and summary conclusions will be published in a peer reviewed scientific journal.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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