Clinical trial NCT04075279: Heart at Work Study
Official title: Cardiovascular Mechanisms of the Occupational Physical Activity Health Paradox: 24-hour Physical Activity, Blood Pressure, and Heart Rate
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Occupational Diseases
Cardiovascular Diseases
Cardiovascular Risk Factor
Occupational Exposure
Lead sponsor: University of Pittsburgh
Sponsor class: OTHER
First posted: 2019-08-30
Enrollment: 19
Sex: MALE
Minimum age (years): 35
Maximum age (years): 59
Standard ages: ADULT
Observational model: CASE_CROSSOVER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Middle-aged male food service workers

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).

Eligibility criteria: 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.

Primary outcomes:
measure: 24-hour Heart Rate
timeFrame: 24 hours
Secondary outcomes:
measure: 24-hour Ambulatory Systolic Blood Pressure
timeFrame: 24 hours
measure: Nocturnal Heart Rate Variability, RMSSD
timeFrame: approximately 8 hours (sleep time)
measure: Physical Activity Pattern. Steps Per Day
timeFrame: 1 week
measure: Nocturnal Heart Rate Variability, SDNN
timeFrame: approximately 8 hours (sleep time)
measure: Nocturnal Heart Rate Variability, LF
timeFrame: approximately 8 hours (sleep time)
measure: Nocturnal Heart Rate Variability, HF
timeFrame: approximately 8 hours (sleep time)
measure: Physical Activity Pattern. MVPA
timeFrame: 1 week
measure: Physical Activity Pattern. LPA
timeFrame: 1 week
measure: Physical Activity Pattern. Sedentary
timeFrame: 1 week
measure: Physical Activity Pattern. Upright
timeFrame: 1 week
measure: 24-hour Ambulatory Diastolic Blood Pressure
timeFrame: 24 hours
Other outcomes:
Locations:
city: Pittsburgh
country: United States
facility: Physical Activity and Weight Management Research Laboratory
state: Pennsylvania
Study officials:
affiliation: Graduate Student
name: Tyler D Quinn, MS
role: PRINCIPAL_INVESTIGATOR
References: