- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04613856
Water Bolus Volumes During Continuous Exercise in Heat
November 2, 2020 updated by: Riana Pryor, State University of New York at Buffalo
Hydration is important to all individuals including occupational workers who complete physical activity in the heat.
Current best practice guidelines suggest drinking a cup of water every 15-20 minutes during activity in a hot environment, but research shows this may not be ideal for best maintaining hydration.
The goal of this study is to determine if larger, more frequent water boluses better maintain hydration than smaller, less frequent water boluses during moderate intensity physical activity in the heat.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
16
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
Male
Description
Inclusion Criteria:
- Male
- 18-39 y old
- Self-reported to be healthy
Exclusion Criteria:
- Female
- Not within defined age range
- History of any cardiovascular, neurologic, or metabolic disease
- Current tobacco use or regular use within the last 2 years.
- Taking medications with known thermoregulatory or cardiovascular effects (e.g., aspirin, beta blockers, diuretics, psychotropics, etc.)
- Inability to follow the rules of the protocols or understand the consent form
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
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: Current Best Practice - 237 mL water bolus
|
Subjects consume 237 mL of water every 20 minutes during 2 hours of high intensity work in the heat.
|
EXPERIMENTAL: New Intervention - 500 mL water bolus
|
Subjects consume 500 mL of water every 40 minutes during 2 hours of high intensity work in the heat.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percent body mass loss
Time Frame: 2 hours
|
Percent body mass loss after water intake
|
2 hours
|
Core temperature
Time Frame: 2 hours
|
Core temperature after water intake
|
2 hours
|
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)
April 17, 2019
Primary Completion (ACTUAL)
March 12, 2020
Study Completion (ACTUAL)
March 12, 2020
Study Registration Dates
First Submitted
October 30, 2020
First Submitted That Met QC Criteria
November 2, 2020
First Posted (ACTUAL)
November 3, 2020
Study Record Updates
Last Update Posted (ACTUAL)
November 3, 2020
Last Update Submitted That Met QC Criteria
November 2, 2020
Last Verified
October 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY00003387
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
IPD data can be provided 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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