NCT05491382

Brief Summary

In animal models of thermoregulation (how the body regulates heat), heat-sensitive nerve cells that help regulate body temperature have been identified throughout the body (e.g. in muscles, viscera, and blood vessels, among others); however, in human thermoregulation models, only two locations are generally recognized: the core (brain) and the skin. The limited number of recognized locations in humans are likely due to the difficulty in testing these locations in humans, as these locations are typically identified in animals by sedating them, surgically opening them up, stimulating the area of interest with a hot or cold probe, and then measure thermoregulatory responses. Based on the literature, the researchers believe that by having participants run at the same energy expenditure but at three different inclines (uphill, downhill and flat) on a treadmill, the researchers can independently alter muscle temperature, while keeping core and skin temperature the same. Additionally, recent studies have suggested that temperature has a greater role at regulating blood flow through muscle tissue than previously recognized. Because of this, the researchers aim to have a second arm of the study to see whether these differences in muscle temperature result in differences in post-exercise blood flow to the muscle. Finally, downhill running is often used to study exercise-induced muscle damage, due to the greater breaking forces compared to flat land running. Because of this, a third study aim will be to examine the association between fitness level, body morphology and sex on exercise-induced muscle damage.

Trial Health

45
At Risk

Trial Health Score

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

Timeline
7mo left

Started Dec 2024

Typical duration for not_applicable

Status
withdrawn

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress72%
Dec 2024Dec 2026

First Submitted

Initial submission to the registry

July 26, 2022

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
2.3 years until next milestone

Study Start

First participant enrolled

December 1, 2024

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2025

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 18, 2025

Status Verified

December 1, 2023

Enrollment Period

1 year

First QC Date

July 26, 2022

Last Update Submit

February 14, 2025

Conditions

Outcome Measures

Primary Outcomes (9)

  • Core temperature

    Measured by rectal and esophageal temperature

    Immediately after completing the intervention

  • Skin temperature

    Measured at 8 sites using the ISO 9886 weighting system

    Immediately after completing the intervention

  • Muscle temperature

    Measured at 4 locations: vastus lateralis, bicep femoris, lateral gastrocnemius and deltoid

    Immediately after completing the intervention

  • Whole-body sweat rate (arm 1)

    Measured pre and post exercise with a platform scale (accurate to 1 g)

    Immediately after completing the intervention

  • Femoral blood flow (arm 2)

    Measured using Ultrasound Doppler

    1 hour after completing the intervention

  • Blood pressure (arm 2)

    Measured using a standard blood pressure cuff and finger photoplethysmography

    1 hour after completing the intervention

  • Perceived muscle pain (arm 3)

    Self-reported on a 100 mm likert scale ranging from "no pain or discomfort" to "maximal pain and discomfort"

    Assessed 48 hours after the completing exercise

  • Maximal voluntary contraction (arm 3)

    The maximal force (in N) generated by the right leg during an isometric leg extension, with the knee at 90 degrees

    Assessed 48 hours after the completing exercise

  • Plasma creatinine levels (arm 3)

    Measured from blood taken from an ante cubital vein

    Assessed 48 hours after the completing exercise

Secondary Outcomes (6)

  • Oxygen consumption

    Average oxygen consumption over the 60 min of exercise

  • Local sweat rate

    Average local sweat rate over the 60 min of exercise

  • Skin blood flow

    Average skin blood flow over the 60 min of exercise

  • Heart rate

    Average heart rate over the 60 min of exercise

  • Perceived exertion

    Average perceived exertion over the 60 min of exercise

  • +1 more secondary outcomes

Study Arms (3)

Does muscle temperature influence heat loss responses independently from core and skin temperature?

EXPERIMENTAL

The study will consist of three experimental trials, conducted in a randomized order, where participants will be required to run for one hour at \~60% of their maximal oxygen consumption on one of three different inclines: 1) flatland, 2) uphill, and 3) downhill. Environmental conditions will be maintained at 34°C/93°F and 20% relative humidity.

Procedure: Uphill runningProcedure: Flatland runningProcedure: Downhill running

Does muscle temperature influence muscle blood flow independently from core and skin temperature?

EXPERIMENTAL

Following the exercise protocol described above in Arm 1, the participants will then lay supine for one hour while their muscle and skin blood flow, as well as blood pressure are measured.

Procedure: Uphill runningProcedure: Flatland runningProcedure: Downhill running

What factors contribute to exercise-induced skeletal muscle damage?

EXPERIMENTAL

For those participants who additionally agree to participate in the muscle microdamage portion of the study, participants will be asked to return to the lab 24h and 48h post-trial. During these subsequent follow-up sessions, an additional blood sample will be drawn from the participants, the participants maximal voluntary contraction and muscle pain will be assessed, and they will be asked to fill out the muscle soreness scale.

Procedure: Uphill runningProcedure: Flatland runningProcedure: Downhill running

Interventions

Participants will run at 70% of their maximal oxygen consumption for 60 min at a 10 degree (17.6%) incline.

Does muscle temperature influence heat loss responses independently from core and skin temperature?Does muscle temperature influence muscle blood flow independently from core and skin temperature?What factors contribute to exercise-induced skeletal muscle damage?

Participants will run at 70% of their maximal oxygen consumption for 60 min at a 0 degree (0%) incline.

Does muscle temperature influence heat loss responses independently from core and skin temperature?Does muscle temperature influence muscle blood flow independently from core and skin temperature?What factors contribute to exercise-induced skeletal muscle damage?

Participants will run at 70% of their maximal oxygen consumption for 60 min at a -10 degree (-17.6%) decline.

Does muscle temperature influence heat loss responses independently from core and skin temperature?Does muscle temperature influence muscle blood flow independently from core and skin temperature?What factors contribute to exercise-induced skeletal muscle damage?

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All participants must be healthy with no history of respiratory, metabolic, cardiovascular, blood pressure disease, or of diabetes and must not currently be on any medication related to these or any other conditions. Additionally, due to the potential dangers of elevated body temperatures to the unborn fetus, all female participants must not be pregnant and agree to not to attempt to become pregnant throughout their involvement in the study.

You may not qualify if:

  • Unhealthy, history of respiratory, metabolic, cardiovascular, blood pressure disease, or of diabetes, currently taking medications related to these or that have the possibility of impairing cardiovascular or thermoregulatory function. Any participants that are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Body Temperature ChangesMotor Activity

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Nathan B Morris, PhD

    University of Colorado, Colorado Springs

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 26, 2022

First Posted

August 8, 2022

Study Start

December 1, 2024

Primary Completion

December 1, 2025

Study Completion (Estimated)

December 1, 2026

Last Updated

February 18, 2025

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will share

Upon the completion of the study, a permanent link will be created to the data summary sheet containing the participants' deidentified data, as it was entered in the statistical software program used for the final analysis (Graphpad Prism or SPSS).

Time Frame
Data will be posted upon completion of the study, when the manuscripts are submitted for publication. This data will be available at the provided link for the foreseeable future.
Access Criteria
Open to all.