Back to resultsComparison of Fatigue in Varying Hot Environments
Primary Purpose
Hyperthermia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Hot/Dry
Warm/Humid
Sponsored by
About this trial
This is an interventional other trial for Hyperthermia
Eligibility Criteria
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
Sites / Locations
- Center for Research and Exercise in Special Environments
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Hot/Dry
Warm/Humid
Arm Description
Outcomes
Primary Outcome Measures
Smoothness of movement
The variable, jerk, determines smoothness or unevenness of physical movement during work. This is measured using accelerometers placed along the spine, ankle, and shoulder.
Energy Expenditure
The amount of energy the body is expending during work. This is measured using indirect calorimetry.
Secondary Outcome Measures
Perceptual fatigue
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".
Full Information
NCT ID
NCT04624919
First Posted
October 30, 2020
Last Updated
October 13, 2021
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT04624919
Brief Title
Comparison of Fatigue in Varying Hot Environments
Official Title
Comparison of Fatigue in Varying Hot Environments
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
December 10, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
June 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
State University of New York at Buffalo
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the impact of varying hot environments on physiological and perceptual fatigue during work.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hyperthermia
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized, counterbalanced crossover design
Masking
None (Open Label)
Allocation
Randomized
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hot/Dry
Arm Type
Active Comparator
Arm Title
Warm/Humid
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Hot/Dry
Intervention Description
Work is completed in a hot/dry environment.
Intervention Type
Other
Intervention Name(s)
Warm/Humid
Intervention Description
Work is completed in a warm/humid environment
Primary Outcome Measure Information:
Title
Smoothness of movement
Description
The variable, jerk, determines smoothness or unevenness of physical movement during work. This is measured using accelerometers placed along the spine, ankle, and shoulder.
Time Frame
90 minutes
Title
Energy Expenditure
Description
The amount of energy the body is expending during work. This is measured using indirect calorimetry.
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Perceptual fatigue
Description
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".
Time Frame
90 minutes
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Center for Research and Exercise in Special Environments
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Individual participant data can be made available upon written request.
Learn more about this trial
Comparison of Fatigue in Varying Hot Environments
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