Trial Outcomes & Findings for Heat Acclimation, Hand Cooling Efficacy, and Adaptation Maintenance. (NCT NCT04053465)

NCT ID: NCT04053465

Last Updated: 2020-02-27

Results Overview

Rectal temperature was assessed five days following measurement at baseline.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 34 participants
• Primary outcome timeframe: 5 days
• Results posted on: 2020-02-27

Participant Flow

Participants were excluded if they did not reach the aerobic fitness criteria or if there were foreseen scheduling conflicts.

Participant milestones

Measure	Exercise in Heat Group Exercise in a hot environment Heat acclimation: 14 days of aerobic exercise in a hot environment	Exercise in Cool Group Exercise in a cool environment Exercise in a cool environment: 14 days of aerobic exercise in a cool environment
Overall Study STARTED	22	12
Overall Study COMPLETED	18	8
Overall Study NOT COMPLETED	4	4

Reasons for withdrawal

Measure	Exercise in Heat Group Exercise in a hot environment Heat acclimation: 14 days of aerobic exercise in a hot environment	Exercise in Cool Group Exercise in a cool environment Exercise in a cool environment: 14 days of aerobic exercise in a cool environment
Overall Study Withdrawal by Subject	4	4

Baseline Characteristics

Heat Acclimation, Hand Cooling Efficacy, and Adaptation Maintenance.

Baseline characteristics by cohort

Measure	Exercise in Heat Group n=22 Participants Exercise in a hot environment Heat acclimation: 14 days of aerobic exercise in a hot environment	Exercise in Cool Group n=12 Participants Exercise in a cool environment Exercise in a cool environment: 14 days of aerobic exercise in a cool environment	Total n=34 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	22 Participants n=5 Participants	12 Participants n=7 Participants	34 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	22 Participants n=5 Participants	12 Participants n=7 Participants	34 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	12 Participants n=7 Participants	32 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants	12 participants n=7 Participants	34 participants n=5 Participants
VO2max	53.5 mL/kg/min STANDARD_DEVIATION 1.7 • n=5 Participants	56.9 mL/kg/min STANDARD_DEVIATION 2.2 • n=7 Participants	54.6 mL/kg/min STANDARD_DEVIATION 5.3 • n=5 Participants

PRIMARY outcome

Timeframe: 5 days

Rectal temperature was assessed five days following measurement at baseline.

Outcome measures

Measure	Exercise in Heat Group n=22 Participants Exercise in a hot environment Heat acclimation: 14 days of aerobic exercise in a hot environment	Exercise in Cool Group n=12 Participants Exercise in a cool environment Exercise in a cool environment: 14 days of aerobic exercise in a cool environment
Internal Body Temperature	39.6 degrees Celcius Standard Deviation 0.47	38.2 degrees Celcius Standard Deviation 0.30

SECONDARY outcome

Timeframe: 5 days

Heart rate was assessed five days following baseline.

Outcome measures

Measure	Exercise in Heat Group n=22 Participants Exercise in a hot environment Heat acclimation: 14 days of aerobic exercise in a hot environment	Exercise in Cool Group n=12 Participants Exercise in a cool environment Exercise in a cool environment: 14 days of aerobic exercise in a cool environment
Heart Rate	178 beats per minute Standard Deviation 17	173 beats per minute Standard Deviation 4

Adverse Events

Exercise in Heat Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Exercise in Cool Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Riana Pryor

University at Buffalo

Phone: 7168295456

Email: rpryor@buffalo.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place