NCT04053465

Brief Summary

This study had three aims:

  1. 1.To determine the impact of consecutive days of exercise on thermoregulation and cardiovascular strain.
  2. 2.To determine the efficacy of a hand cooling device to cool individuals throughout a heat acclimation period.
  3. 3.To assess the maintenance of thermoregulatory and cardiovascular adaptations derived from heat acclimation during a 25-day intermittent exercise-heat exposure protocol.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2014

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2014

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2015

Completed
4.4 years until next milestone

First Submitted

Initial submission to the registry

August 7, 2019

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 12, 2019

Completed
7 months until next milestone

Results Posted

Study results publicly available

February 27, 2020

Completed
Last Updated

February 27, 2020

Status Verified

February 1, 2020

Enrollment Period

8 months

First QC Date

August 7, 2019

Results QC Date

January 6, 2020

Last Update Submit

February 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Internal Body Temperature

    Rectal temperature was assessed five days following measurement at baseline.

    5 days

Secondary Outcomes (1)

  • Heart Rate

    5 days

Study Arms (2)

Exercise in heat group

EXPERIMENTAL

Exercise in a hot environment

Other: Heat acclimation

Exercise in cool group

PLACEBO COMPARATOR

Exercise in a cool environment

Other: Exercise in a cool environment

Interventions

14 days of aerobic exercise in a hot environment

Exercise in heat group

14 days of aerobic exercise in a cool environment

Exercise in cool group

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • women
  • exercise less than once per week
  • VO2max \< 45 ml/kg/min

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Pryor RR, Pryor JL, Vandermark LW, Adams EL, Brodeur RM, Armstrong LE, Lee EC, Maresh CM, Casa DJ. Short term heat acclimation reduces heat strain during a first, but not second, consecutive exercise-heat exposure. J Sci Med Sport. 2021 Aug;24(8):768-773. doi: 10.1016/j.jsams.2021.03.020. Epub 2021 Apr 6.

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Results Point of Contact

Title
Dr. Riana Pryor
Organization
University at Buffalo

Study Officials

  • Douglas J Casa, PhD

    University of Connecticut

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 7, 2019

First Posted

August 12, 2019

Study Start

August 1, 2014

Primary Completion

March 31, 2015

Study Completion

March 31, 2015

Last Updated

February 27, 2020

Results First Posted

February 27, 2020

Record last verified: 2020-02

Data Sharing

IPD Sharing
Will not share

Aggregate data can be shared upon request.