- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05327764
Work-To-Rest Ratios
November 8, 2023 updated by: Riana Pryor, State University of New York at Buffalo
The purpose of the study is to compare physiological responses to two hours of work adhering to two variations of a work-to-rest ratio in a hot environment.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
15
Phase
- Not Applicable
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
-
-
New York
-
Buffalo, New York, United States, 14214
- University at Buffalo
-
-
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
18 years to 39 years (Adult)
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- Healthy 18-39 year old individuals
- Physically active
Exclusion Criteria:
- History of cardiovascular, metabolic, respiratory, neural, or renal disease
- Hypertensive or tachycardic during the screening visit (systolic blood pressure ≥ 140 mmHg, diastolic blood pressure ≥ 90 mmHg, resting heart rate ≥ 100 bpm)
- Taking medication or supplements with a known side effect of affecting physiologic responses to exercise (e.g., acetaminophen, beta blockers, statins, aspirin)
- Any form of tobacco or nicotine use in the past six months
- Current musculoskeletal injury impacting physical activity
- A positive pregnancy test at any point in the study
- Study physician discretion based on any other medical condition or medication
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
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: 40:20
Walking for 40 minutes, resting for 20
|
Walking in a hot environment for 2 hours with repeated 40 minutes of work and 20 minutes of rest
|
Experimental: 20:10
Walking for 40 minutes, resting for 20
|
Walking in a hot environment for 2 hours with repeated 20 minutes of work and 10 minutes of rest
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in core body temperature
Time Frame: Upon completion of 2 hours of the work protocol
|
Core body temperature is measured using a rectal thermistor
|
Upon completion of 2 hours of the work protocol
|
Change in heart rate
Time Frame: Upon completion of 80 minutes of work
|
Heart rate is measured using a telemetry strap
|
Upon completion of 80 minutes of work
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Riana Pryor, PhD, University at Buffalo
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)
March 21, 2022
Primary Completion (Actual)
November 5, 2023
Study Completion (Actual)
November 5, 2023
Study Registration Dates
First Submitted
March 26, 2022
First Submitted That Met QC Criteria
April 7, 2022
First Posted (Actual)
April 14, 2022
Study Record Updates
Last Update Posted (Estimated)
November 9, 2023
Last Update Submitted That Met QC Criteria
November 8, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00006115
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
We do not plan to share these data with other researchers.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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