Occupational DiseasesNCT04075279
Heart at Work Study
An observational study of Occupational Diseases and Cardiovascular Diseases, run by University of Pittsburgh at 1 site in United States.
Trial summary
This is an observational study to examine the cardiovascular mechanisms of increased cardiovascular mortality in those with high activity occupations. Read more about this study
- Who is it for?
- Ages 35 to 59 years, men only
- Conditions the study is for
- Occupational Diseases, Cardiovascular Diseases, Cardiovascular Risk Factor
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2019to 24 Jul 2020
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 59 years
- Men only
- Adult
Study population: Middle-aged male food service workers
Who may be able to join
- 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)
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Physical Activity and Weight Management Research Laboratory
Pittsburgh, Pennsylvania, 15261
About this study
Official title: 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.
Read the 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).
- Conditions
- Occupational Diseases, Cardiovascular Diseases, Cardiovascular Risk Factor, Occupational Exposure
- Medical subject headings
- Occupational Diseases, Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour Heart Rate
We will calculate the average heart rate over each 24 hour period throughout a one week monitoring period.
Measured: 24 hours
Secondary outcomes (11)
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).
Measured: 24 hours
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).
Measured: approximately 8 hours (sleep time)
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
Measured: 1 week
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).
Measured: approximately 8 hours (sleep time)
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).
Measured: approximately 8 hours (sleep time)
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).
Measured: approximately 8 hours (sleep time)
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
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
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
Measured: 1 week
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).
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2019
- Study start17 Oct 2019
- Primary completion20 Apr 2020
- Study completion24 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Occupational DiseasesStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler Quinn, University of Pittsburgh
- Investigators
- Tyler D Quinn, MS, Principal investigator, Graduate Student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04075279
- Sponsor's protocol ID
- STUDY19050097
- Status last verified
- Apr 2021
- First submitted
- 28 Aug 2019
- Last updated
- 3 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Upon completion of all data collection, data will be analyzed and summary conclusions will be published in a peer reviewed scientific journal.
Publications
Quinn TD, Bruehwiler T, Chantler PD, Gibbs BB. Cardiovascular Responses to Occupational Physical Activity Are Exaggerated by Work-Related Stress and Low Fitness. J Occup Environ Med. 2024 Oct 1;66(10):e476-e482. doi: 10.1097/JOM.0000000000003183. Epub 2024 Jul 1.
PubMed 38955811
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Mechanisms of the Occupational Physical Activity Health Paradox: 24-hour Physical Activity, Blood Pressure, and Heart Rate
- ClinicalTrials.gov ID
- NCT04075279
- Acronym / sponsor ID
- STUDY19050097
- Conditions
- Occupational Diseases, Cardiovascular Diseases, Cardiovascular Risk Factor, Occupational Exposure
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- 17 Oct 2019 (actual)
- Primary completion
- 20 Apr 2020 (actual)
- Study completion
- 24 Jul 2020 (actual)
- First posted
- 30 Aug 2019 (actual)
- Results
- Posted 3 May 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Case crossover
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 35 to 59 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Middle-aged male food service workers
Key inclusion criteria (4 listed)
- 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)
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
24-hour Ambulatory Systolic Blood Pressure
Time frame: 24 hours
Nocturnal Heart Rate Variability, RMSSD
Time frame: approximately 8 hours (sleep time)
Physical Activity Pattern. Steps Per Day
Time frame: 1 week
Nocturnal Heart Rate Variability, SDNN
Time frame: approximately 8 hours (sleep time)
Nocturnal Heart Rate Variability, LF
Time frame: approximately 8 hours (sleep time)
Nocturnal Heart Rate Variability, HF
Time frame: approximately 8 hours (sleep time)
Physical Activity Pattern. MVPA
Time frame: 1 week
Physical Activity Pattern. LPA
Time frame: 1 week
Physical Activity Pattern. Sedentary
Time frame: 1 week
Physical Activity Pattern. Upright
Time frame: 1 week
24-hour Ambulatory Diastolic Blood Pressure
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38955811Quinn TD, Bruehwiler T, Chantler PD, Gibbs BB. Cardiovascular Responses to Occupational Physical Activity Are Exaggerated by Work-Related Stress and Low Fitness. J Occup Environ Med. 2024 Oct 1;66(10):e476-e482. doi: 10.1097/JOM.0000000000003183. Epub 2024 Jul 1.
- Individual participant dataSharing planned: No. Upon completion of all data collection, data will be analyzed and summary conclusions will be published in a peer reviewed scientific journal.
Related trials for Occupational Diseases
Enrolling by invitationObservational study
Collection and Distribution of Samples From Healthy Donors for In Vitro Research at the NCI-Frederick
Healthy Donors
RecruitingPhase 4
Lemborexant in Delayed Sleep Phase Syndrome
Delayed Sleep Phase Syndrome
Recruiting
Development & Validation of a Life Balance Program for Parents of Preschoolers: A Pilot Study
Parenting Stress, Mental Health
Enrolling by invitation
PATH to Reducing Burnout Among Peers Who Deliver Overdose Prevention Services (R33 Phase Clinical Trial)
Burnout, Secondary Trauma
Recruiting
Structured Sensory-Based Occupational Therapy in Children With Autism
Autism Spectrum Disorder
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tyler D Quinn, MS principal investigator
Graduate Student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Occupational Diseases and Cardiovascular Diseases, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 May 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24-hour Heart Rate (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04075279, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.