NCT05327764

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Geographic Reach
1 country

1 active site

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

March 21, 2022

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

March 26, 2022

Completed
19 days until next milestone

First Posted

Study publicly available on registry

April 14, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 5, 2023

Completed
Last Updated

November 9, 2023

Status Verified

November 1, 2023

Enrollment Period

1.6 years

First QC Date

March 26, 2022

Last Update Submit

November 8, 2023

Conditions

Outcome Measures

Primary Outcomes (2)

  • Change in core body temperature

    Core body temperature is measured using a rectal thermistor

    Upon completion of 2 hours of the work protocol

  • Change in heart rate

    Heart rate is measured using a telemetry strap

    Upon completion of 80 minutes of work

Study Arms (2)

40:20

ACTIVE COMPARATOR

Walking for 40 minutes, resting for 20

Other: Work to rest cycles of 40:20 minutes

20:10

EXPERIMENTAL

Walking for 40 minutes, resting for 20

Other: Work to rest cycles of 20:10 minutes

Interventions

Walking in a hot environment for 2 hours with repeated 40 minutes of work and 20 minutes of rest

40:20

Walking in a hot environment for 2 hours with repeated 20 minutes of work and 10 minutes of rest

20:10

Eligibility Criteria

Age18 Years - 39 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy 18-39 year old individuals
  • Physically active

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University at Buffalo

Buffalo, New York, 14214, United States

Location

MeSH Terms

Conditions

Hyperthermia

Condition Hierarchy (Ancestors)

Body Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsHeat Stress DisordersWounds and Injuries

Study Officials

  • Riana Pryor, PhD

    University at Buffalo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
CROSSOVER
Model Details: Randomized counterbalanced study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

March 26, 2022

First Posted

April 14, 2022

Study Start

March 21, 2022

Primary Completion

November 5, 2023

Study Completion

November 5, 2023

Last Updated

November 9, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

We do not plan to share these data with other researchers.

Locations