- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04624919
Comparison of Fatigue in Varying Hot Environments
October 13, 2021 updated by: Riana Pryor, State University of New York at Buffalo
The purpose of this study is to determine the impact of varying hot environments on physiological and perceptual fatigue during work.
Study Overview
Detailed Description
After providing written informed consent and screening, subjects will complete two experimental visits during which they will complete treadmill work in either a hot/dry or warm/humid environment.
Study Type
Interventional
Enrollment (Actual)
13
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
- Center for Research and Exercise in Special Environments
-
-
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
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 18-39 y old men and women
- Self-reported to be healthy
Exclusion Criteria:
- History of any cardiovascular, neurologic, renal, or metabolic disease
- Current tobacco use or regular use within the last 2 years
- Current musculoskeletal injury
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, acetaminophen, ibuprofen, beta blockers, diuretics, psychotropics, etc.)
- Currently pregnant or breastfeeding, or planning to become pregnant during the study
- Inability to follow the rules of the protocols or understand the consent form
- Contraindications of consuming a core temperature monitoring pill
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: Other
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Hot/Dry
|
Work is completed in a hot/dry environment.
|
Experimental: Warm/Humid
|
Work is completed in a warm/humid environment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Smoothness of movement
Time Frame: 90 minutes
|
The variable, jerk, determines smoothness or unevenness of physical movement during work.
This is measured using accelerometers placed along the spine, ankle, and shoulder.
|
90 minutes
|
Energy Expenditure
Time Frame: 90 minutes
|
The amount of energy the body is expending during work.
This is measured using indirect calorimetry.
|
90 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Perceptual fatigue
Time Frame: 90 minutes
|
The degree of fatigue that the subjects perceive during work.
This is measured using a subjective likert 0-10 scale named the Fatigue Scale with 0 indicting "no fatigue at all" and 10 indicating "completely fatigued".
|
90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
December 10, 2019
Primary Completion (Actual)
June 30, 2021
Study Completion (Actual)
June 30, 2021
Study Registration Dates
First Submitted
October 30, 2020
First Submitted That Met QC Criteria
November 5, 2020
First Posted (Actual)
November 12, 2020
Study Record Updates
Last Update Posted (Actual)
October 14, 2021
Last Update Submitted That Met QC Criteria
October 13, 2021
Last Verified
October 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00004012
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Individual participant data can be made available upon written request.
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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