Back to resultsWork-To-Rest Ratios
Primary Purpose
Hyperthermia
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Work to rest cycles of 40:20 minutes
Work to rest cycles of 20:10 minutes
Sponsored by
About this trial
This is an interventional prevention trial for Hyperthermia
Eligibility Criteria
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
Sites / Locations
- University at BuffaloRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
40:20
20:10
Arm Description
Walking for 40 minutes, resting for 20
Walking for 40 minutes, resting for 20
Outcomes
Primary Outcome Measures
Change in core body temperature
Core body temperature is measured using a rectal thermistor
Change in heart rate
Heart rate is measured using a telemetry strap
Secondary Outcome Measures
Full Information
NCT ID
NCT05327764
First Posted
March 26, 2022
Last Updated
September 20, 2023
Sponsor
State University of New York at Buffalo
1. Study Identification
Unique Protocol Identification Number
NCT05327764
Brief Title
Work-To-Rest Ratios
Official Title
Work-To-Rest Ratios
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 21, 2022 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
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 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.
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
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized counterbalanced study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
40:20
Arm Type
Active Comparator
Arm Description
Walking for 40 minutes, resting for 20
Arm Title
20:10
Arm Type
Experimental
Arm Description
Walking for 40 minutes, resting for 20
Intervention Type
Other
Intervention Name(s)
Work to rest cycles of 40:20 minutes
Intervention Description
Walking in a hot environment for 2 hours with repeated 40 minutes of work and 20 minutes of rest
Intervention Type
Other
Intervention Name(s)
Work to rest cycles of 20:10 minutes
Intervention Description
Walking in a hot environment for 2 hours with repeated 20 minutes of work and 10 minutes of rest
Primary Outcome Measure Information:
Title
Change in core body temperature
Description
Core body temperature is measured using a rectal thermistor
Time Frame
Upon completion of 2 hours of the work protocol
Title
Change in heart rate
Description
Heart rate is measured using a telemetry strap
Time Frame
Upon completion of 80 minutes of work
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:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Riana Pryor, PhD
Phone
7168295456
Email
rpryor@buffalo.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jocelyn Stooks, MPH
Email
jstooks@buffalo.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Riana Pryor, PhD
Organizational Affiliation
University at Buffalo
Official's Role
Principal Investigator
Facility Information:
Facility Name
University at Buffalo
City
Buffalo
State/Province
New York
ZIP/Postal Code
14214
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Riana Pryor, PhD
Phone
716-829-5456
Email
rpryor@buffalo.edu
First Name & Middle Initial & Last Name & Degree
Jocelyn Stooks, MPH
Email
jstooks@buffalo.edu
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
We do not plan to share these data with other researchers.
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Work-To-Rest Ratios
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