Study Stopped
Technical malfunctions of key equipment delayed the study for over a year. During this time, lab priorities and direction shifted and this study is no longer being conducted.
Muscle and Body Temperature Responses During Uphill and Downhill Running
1 other identifier
interventional
N/A
0 countries
N/A
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Dec 2024
Typical duration for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 26, 2022
CompletedFirst Posted
Study publicly available on registry
August 8, 2022
CompletedStudy Start
First participant enrolled
December 1, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedFebruary 18, 2025
December 1, 2023
1 year
July 26, 2022
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?
EXPERIMENTALThe 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.
Does muscle temperature influence muscle blood flow independently from core and skin temperature?
EXPERIMENTALFollowing 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.
What factors contribute to exercise-induced skeletal muscle damage?
EXPERIMENTALFor 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.
Interventions
Participants will run at 70% of their maximal oxygen consumption for 60 min at a 10 degree (17.6%) incline.
Participants will run at 70% of their maximal oxygen consumption for 60 min at a 0 degree (0%) incline.
Participants will run at 70% of their maximal oxygen consumption for 60 min at a -10 degree (-17.6%) decline.
Eligibility Criteria
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
- CommonSpirit Healthlead
- University of Colorado, Colorado Springscollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nathan B Morris, PhD
University of Colorado, Colorado Springs
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
- 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.
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).