- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04053465
Heat Acclimation, Hand Cooling Efficacy, and Adaptation Maintenance.
February 13, 2020 updated by: Douglas J Casa, University of Connecticut
The Effect of Heat Acclimation on Repeated Bouts of Strenuous Heat Stress, Hand Cooling Efficacy, and the Maintenance Thereof.
This study had three aims:
- To determine the impact of consecutive days of exercise on thermoregulation and cardiovascular strain.
- To determine the efficacy of a hand cooling device to cool individuals throughout a heat acclimation period.
- To assess the maintenance of thermoregulatory and cardiovascular adaptations derived from heat acclimation during a 25-day intermittent exercise-heat exposure protocol.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Participants completed 14 days of exercise heat acclimation in either a hot or cool environment, followed by a heat or cool exercise exposure every 5th day for 25 days.
Cardiovascular, thermoregulatory, and perceptual strain were measured throughout exercise each day.
Hydration assessment and stress response via blood biomarkers were measured before and after exercise.
Aerobic capacity was measured before and after heat acclimation as well as after the intermittent exercise-heat exposure.
Hand cooling was implemented periodically during exercise-heat stress visits to determine cooling efficacy before and after heat acclimation.
Study Type
Interventional
Enrollment (Actual)
34
Phase
- Not Applicable
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 35 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- no chronic health problems
- no previous history of exertional heat stroke within the past 3 years
- no history of cardiovascular, metabolic or respiratory disease
- no current musculoskeletal injury that limits physical activity
Exclusion Criteria:
- women
- exercise less than once per week
- VO2max < 45 ml/kg/min
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: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise in heat group
Exercise in a hot environment
|
14 days of aerobic exercise in a hot environment
|
|
Placebo Comparator: Exercise in cool group
Exercise in a cool environment
|
14 days of aerobic exercise in a cool environment
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Internal Body Temperature
Time Frame: 5 days
|
Rectal temperature was assessed five days following measurement at baseline.
|
5 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Heart Rate
Time Frame: 5 days
|
Heart rate was assessed five days following baseline.
|
5 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Douglas J Casa, PhD, University of Connecticut
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the 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)
August 1, 2014
Primary Completion (Actual)
March 31, 2015
Study Completion (Actual)
March 31, 2015
Study Registration Dates
First Submitted
August 7, 2019
First Submitted That Met QC Criteria
August 9, 2019
First Posted (Actual)
August 12, 2019
Study Record Updates
Last Update Posted (Actual)
February 27, 2020
Last Update Submitted That Met QC Criteria
February 13, 2020
Last Verified
February 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- H14-188
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
Aggregate data can be shared upon 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.