Body Temperature ChangesNCT05491382
Muscle and Body Temperature Responses During Uphill and Downhill Running
A study testing Uphill running, Flatland running and Downhill running in people with Body Temperature Changes and Exercise, run by CommonSpirit Health.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Body Temperature Changes, Exercise, Blood Pressure
- What is being tested?
- Uphill running, Flatland running and Downhill running
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
About this study
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.
Read the detailed description
Primary aim: To alter muscle temperature independently from core and skin temperature, to investigate the existence of temperature sensitive nerve cells in human muscle tissue.
In animal models of thermoregulatory control, multiple loci of thermal sensation have been identified, including in the muscle, veins in the skin and abdomen, spinal column, upper airway, abdominal wall, lower esophagus, stomach, and small intestine. In contrast to these animal models, in human models of thermoregulatory control, typically, only thermal inputs from the brain (usually represented as "core" temperature, with proxy measures taken at the esophagus, rectum, intestine, or aural canal) are considered, along with further inputs from the skin that modify the central brain signaling.
The limited number of recognized thermally sensitive locations in humans are likely not due to a truly small number of thermally sensitive loci, but rather, due to the difficulty in testing these locations in humans. Indeed, the typical model for identifying thermally sensitive locations in animals is to sedate them, surgically open them up, stimulate the area of interest with a hot or cold probe, and then measure thermoregulatory responses; a protocol that is clearly unacceptable in humans.
Supporting the idea that the lack of recognized thermally sensitive locations is due to testing limitations, rather than an actual non-existence of physical locations, the principal researcher on the current application (Dr. Morris) previously conducted a series of studies providing evidence for the existence of thermoreceptors in the human abdomen. Indeed, recent reviews regarding human thermoregulatory control have updated the number of thermally sensitive sites to include the abdomen.
In the present study proposal, the investigators believe to have identified a protocol which would identify another thermally-sensitive location: human skeletal muscle.
The method for measuring heat balance in humans can be expressed using the following equation:
M ± W = K ± C ± R + E
Where M is metabolic energy expenditure, W is the amount of energy exchanged with the environment via mechanical work, K is conduction, C is convection, R is radiation and E is evaporation. Here, if M ± W exceeds K ± C ± R + E, there will be heat storage in the body and core temperatures will rise. Conversely, if K ± C ± R + E exceeds M ± W, there will be a net heat loss from the body and core temperatures will decrease. However, as humans are homeotherms, the body will typically regulate itself so that both sides of the equation are equal. With heat stress, this is primarily done through an increase in sweating that increases evaporative heat loss.
From the above, this would indicate that if the external work is manipulated while metabolic energy expenditure is kept constant, a proportional, inverse change on the heat loss side of the equation (primarily through evaporation) is required. One way to manipulate external work is by running at different inclines and declines, as the amount of external work performed during running can be calculated as the vertical displacement of the individual, multiplied by their mass and acceleration due to gravity.
This type of study protocol has only been employed twice: both times in the 1960s and both using only three male participants. In the first study, it was observed that when running uphill compared to flatland, evaporative heat loss was lower (due to decreased sweating) by the exact amount of energy as calculated to how much was lost to the environment via external work (as would be predicted). Of note, however, was that core and skin temperature - the two recognized thermally sensitive areas in humans - were similar between both trials. Similarly, in the second study, when running uphill compared to flatland, evaporative heat loss decreased (consequent of decreased sweating) proportionally to the amount of heat lost to external work from running uphill. Also, when running downhill compared to running uphill, the evaporative heat loss increased (due to increased sweating) in proportion to the amount of heat that the was gained from the environment from running downhill. Again, core and skin temperature were similar in all three trials.
The change in evaporative heat loss (consequent of changes in sweating) combined with the lack of difference in core and skin temperature in both studies suggests the existence of thermoreceptors in a bodily location other than the core and skin. The most likely area being the muscles of the leg, as was noted by the author in the second study. The reason for this can be explained accordingly:
Imagine riding a bicycle. The energy needed to get a person moving is produced within the body, however, the energy to slow a person down is produced by activating their brakes, which causes friction between the brakes and their tires and the tires and the road. If a person were to touch their brakes and tires after applying the brakes, both tires and brakes would feel hot due to the friction used to slow the person down. Humans do not have external brakes like bicycles, but instead, rely on their legs to do both the accelerating and braking. As more work needs to be done to overcome gravity while going uphill compared to flatland running, the horizontal component (i.e. horizontal running speed) will be slower when running at an equivalent metabolic energy expenditure. Conversely, when running downhill compared to flatland, the body is being "helped" by gravity, and therefore, to maintain an equivalent energy expenditure, the person needs to run faster. Accordingly, more braking actions occur in the legs while running downhill, resulting in more frictional braking and therefore more heat stored locally within the muscle. This, however, has yet to be confirmed empirically.
Of importance, the two previously conducted studies in which external work was manipulated while metabolic energy expenditure was kept constant included exclusively male participants. Women (at least when tested during the early to mid-follicular phases of the menstrual cycle) appear to have lower end-exercise core and skin temperatures, but higher active/inactive skeletal muscle temperatures, compared to males following exercise. Additionally, mechanisms for whole body evaporative heat loss are attenuated in females compared to males due to a lower sweat gland output and sweat rate. This sex-difference effect seems to become larger in endurance trained versus untrained populations. As such, it is plausible that in situations which demand greater evaporative heat loss to accommodate for more heat stored locally in the skeletal muscle (i.e., downhill running), females will demonstrate a greater increase in muscle temperature relative to flatland running due to an inability to increase sweat rate beyond a certain threshold.
Therefore, if the hypotheses of this study are proved correct, the results from this study would demonstrate that humans have thermoreceptors residing in areas of the body, other than the core and skin, that can affect whole-body heat loss responses. In addition to providing fundamental knowledge about how the human body thermoregulates, these results could affect policies in place regarding whole-body warming and cooling protocols used in emergency, athletic, and surgical scenarios. Furthermore, given the limited amount of thermoregulatory research that has included women, successful completion of this study could influence sex-specific practices for thermal safety.
Secondary aim: Investigate whether muscle temperature influences muscle blood flow, and consequently, post-exercise hypotension.
In addition to answering questions regarding thermoregulatory control, the present study-design's ability to independently alter muscle temperature from skin and core temperature can be used to answer question regarding the effect of local muscle temperature on blood flow. Elevated muscle temperature has been associated with changes in cardiovascular control and greater post exercise vasodilation in the previously active muscle. However, muscle is typically heated externally, which concomitantly alters skin temperature, which also has major effects on local and skin blood flow. Accordingly, the present methodology will allow us to alter muscle temperature while keeping core and skin temperature consistent between trials, allowing us to study the independent effect of muscle temperature on muscle blood flow. Moreover, the investigators believe this will be the first attempt to compare the effects of muscle temperature mediated differences in muscle blood flow between men and women.
Tertiary aim: Downhill running, of similar duration and intensity to the proposed downhill trial in this study (i.e. 60% of maximum oxygen uptake [VO2max], on a -10% decline, for 60 min), is regularly used to study exercise-induced muscle damage. Specifically, previous studies have employed men running for 40 min at 70% VO2max on a -10% decline, 30 min at 70% VO2max on a -15% decline, 60 min at 65% VO2max on a -10% decline, 60 min at 65% VO2max on a -10% decline, and women running for 60 min at 75% VO2max on a -10% decline. Of particular note, although downhill running-induced muscle damage has been studied in men and women, only one within-study sex comparison has been performed. In this study, where participants ran for 30 min at 70% of their VO2max on a -15% incline, it was observed that male participants had higher markers of exercise-induced muscle damage, compared to the female group, 24 h post-exercise. Also, of note, no studies to date have looked at the interactions between sex and incline (i.e. downhill vs flatland vs uphill) on muscle damage. Therefore, the investigators intend to take measures of muscle damage as the investigators are performing these incline running trials anyway.
- Conditions
- Body Temperature Changes, Exercise, Blood Pressure
- Being tested
- Uphill running, Flatland running, Downhill running
- Medical subject headings
- Body Temperature Changes, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Uphill runningProcedure or surgery
Participants will run at 70% of their maximal oxygen consumption for 60 min at a 10 degree (17.6%) incline.
Flatland runningProcedure or surgery
Participants will run at 70% of their maximal oxygen consumption for 60 min at a 0 degree (0%) incline.
Downhill runningProcedure or surgery
Participants will run at 70% of their maximal oxygen consumption for 60 min at a -10 degree (-17.6%) decline.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Uphill running; Procedure: Flatland running; Procedure: 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. Receives: Procedure: Uphill running; Procedure: Flatland running; Procedure: 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. Receives: Procedure: Uphill running; Procedure: Flatland running; Procedure: Downhill running |
What is being measured
The primary outcome is the main question the study is designed to answer.
Core temperature
Measured by rectal and esophageal temperature
Measured: Immediately after completing the intervention
Skin temperature
Measured at 8 sites using the ISO 9886 weighting system
Measured: Immediately after completing the intervention
Muscle temperature
Measured at 4 locations: vastus lateralis, bicep femoris, lateral gastrocnemius and deltoid
Measured: Immediately after completing the intervention
Whole-body sweat rate (arm 1)
Measured pre and post exercise with a platform scale (accurate to 1 g)
Measured: Immediately after completing the intervention
Femoral blood flow (arm 2)
Measured using Ultrasound Doppler
Measured: 1 hour after completing the intervention
Blood pressure (arm 2)
Measured using a standard blood pressure cuff and finger photoplethysmography
Measured: 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"
Measured: 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
Measured: Assessed 48 hours after the completing exercise
Plasma creatinine levels (arm 3)
Measured from blood taken from an ante cubital vein
Measured: Assessed 48 hours after the completing exercise
Secondary outcomes (6)
Oxygen consumption
Measured by expired gas analysis an expressed as liters per minute
Measured: Average oxygen consumption over the 60 min of exercise
Local sweat rate
Measured using the ventilated sweat capsule technic
Measured: Average local sweat rate over the 60 min of exercise
Skin blood flow
Measured using laser doppler
Measured: Average skin blood flow over the 60 min of exercise
Heart rate
Using 3-lead ECG
Measured: Average heart rate over the 60 min of exercise
Perceived exertion
Using the standard 15-point Borg Scale of perceived exertion ranging from no exertion (6) to extremely hard (20)
Measured: Average perceived exertion over the 60 min of exercise
Thermal comfort
Using the Kansas State University 9-point thermal comfort model ranging from very cold (-4) to very hot (4)
Measured: Average thermal comfort over the 60 min of exercise
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2022
- Study start1 Dec 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2026 (estimated)
Why it 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.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Body Temperature ChangesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CommonSpirit Health
- Sponsor type
- University, hospital or other
- Collaborators
- University of Colorado, Colorado Springs
- Responsible party
- Sponsor
- Investigators
- Nathan B Morris, PhD, Principal investigator, University of Colorado, Colorado Springs
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05491382
- Sponsor's protocol ID
- 1864889
- Status last verified
- Dec 2023
- First submitted
- 26 Jul 2022
- Last updated
- 18 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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).
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Muscle and Body Temperature Responses During Uphill and Downhill Running
- ClinicalTrials.gov ID
- NCT05491382
- Acronym / sponsor ID
- 1864889
- Conditions
- Body Temperature Changes, Exercise, Blood Pressure
- Study type
- Interventional
- Recruitment status
- WithdrawnReason 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.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CommonSpirit HealthUniversity, hospital or other
- Collaborators
- University of Colorado, Colorado Springs
- Study start
- 1 Dec 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 8 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Primary aim: To alter muscle temperature independently from core and skin temperature, to investigate the existence of temperature sensitive nerve cells in human muscle tissue.
In animal models of thermoregulatory control, multiple loci of thermal sensation have been identified, including in the muscle, veins in the skin and abdomen, spinal column, upper airway, abdominal wall, lower esophagus, stomach, and small intestine. In contrast to these animal models, in human models of thermoregulatory control, typically, only thermal inputs from the brain (usually represented as "core" temperature, with proxy measures taken at the esophagus, rectum, intestine, or aural canal) are considered, along with further inputs from the skin that modify the central brain signaling.
The limited number of recognized thermally sensitive locations in humans are likely not due to a truly small number of thermally sensitive loci, but rather, due to the difficulty in testing these locations in humans. Indeed, the typical model for identifying thermally sensitive locations in animals is to sedate them, surgically open them up, stimulate the area of interest with a hot or cold probe, and then measure thermoregulatory responses; a protocol that is clearly unacceptable in humans.
Supporting the idea that the lack of recognized thermally sensitive locations is due to testing limitations, rather than an actual non-existence of physical locations, the principal researcher on the current application (Dr. Morris) previously conducted a series of studies providing evidence for the existence of thermoreceptors in the human abdomen. Indeed, recent reviews regarding human thermoregulatory control have updated the number of thermally sensitive sites to include the abdomen.
In the present study proposal, the investigators believe to have identified a protocol which would identify another thermally-sensitive location: human skeletal muscle.
The method for measuring heat balance in humans can be expressed using the following equation:
M ± W = K ± C ± R + E
Where M is metabolic energy expenditure, W is the amount of energy exchanged with the environment via mechanical work, K is conduction, C is convection, R is radiation and E is evaporation. Here, if M ± W exceeds K ± C ± R + E, there will be heat storage in the body and core temperatures will rise. Conversely, if K ± C ± R + E exceeds M ± W, there will be a net heat loss from the body and core temperatures will decrease. However, as humans are homeotherms, the body will typically regulate itself so that both sides of the equation are equal. With heat stress, this is primarily done through an increase in sweating that increases evaporative heat loss.
From the above, this would indicate that if the external work is manipulated while metabolic energy expenditure is kept constant, a proportional, inverse change on the heat loss side of the equation (primarily through evaporation) is required. One way to manipulate external work is by running at different inclines and declines, as the amount of external work performed during running can be calculated as the vertical displacement of the individual, multiplied by their mass and acceleration due to gravity.
This type of study protocol has only been employed twice: both times in the 1960s and both using only three male participants. In the first study, it was observed that when running uphill compared to flatland, evaporative heat loss was lower (due to decreased sweating) by the exact amount of energy as calculated to how much was lost to the environment via external work (as would be predicted). Of note, however, was that core and skin temperature - the two recognized thermally sensitive areas in humans - were similar between both trials. Similarly, in the second study, when running uphill compared to flatland, evaporative heat loss decreased (consequent of decreased sweating) proportionally to the amount of heat lost to external work from running uphill. Also, when running downhill compared to running uphill, the evaporative heat loss increased (due to increased sweating) in proportion to the amount of heat that the was gained from the environment from running downhill. Again, core and skin temperature were similar in all three trials.
The change in evaporative heat loss (consequent of changes in sweating) combined with the lack of difference in core and skin temperature in both studies suggests the existence of thermoreceptors in a bodily location other than the core and skin. The most likely area being the muscles of the leg, as was noted by the author in the second study. The reason for this can be explained accordingly:
Imagine riding a bicycle. The energy needed to get a person moving is produced within the body, however, the energy to slow a person down is produced by activating their brakes, which causes friction between the brakes and their tires and the tires and the road. If a person were to touch their brakes and tires after applying the brakes, both tires and brakes would feel hot due to the friction used to slow the person down. Humans do not have external brakes like bicycles, but instead, rely on their legs to do both the accelerating and braking. As more work needs to be done to overcome gravity while going uphill compared to flatland running, the horizontal component (i.e. horizontal running speed) will be slower when running at an equivalent metabolic energy expenditure. Conversely, when running downhill compared to flatland, the body is being "helped" by gravity, and therefore, to maintain an equivalent energy expenditure, the person needs to run faster. Accordingly, more braking actions occur in the legs while running downhill, resulting in more frictional braking and therefore more heat stored locally within the muscle. This, however, has yet to be confirmed empirically.
Of importance, the two previously conducted studies in which external work was manipulated while metabolic energy expenditure was kept constant included exclusively male participants. Women (at least when tested during the early to mid-follicular phases of the menstrual cycle) appear to have lower end-exercise core and skin temperatures, but higher active/inactive skeletal muscle temperatures, compared to males following exercise. Additionally, mechanisms for whole body evaporative heat loss are attenuated in females compared to males due to a lower sweat gland output and sweat rate. This sex-difference effect seems to become larger in endurance trained versus untrained populations. As such, it is plausible that in situations which demand greater evaporative heat loss to accommodate for more heat stored locally in the skeletal muscle (i.e., downhill running), females will demonstrate a greater increase in muscle temperature relative to flatland running due to an inability to increase sweat rate beyond a certain threshold.
Therefore, if the hypotheses of this study are proved correct, the results from this study would demonstrate that humans have thermoreceptors residing in areas of the body, other than the core and skin, that can affect whole-body heat loss responses. In addition to providing fundamental knowledge about how the human body thermoregulates, these results could affect policies in place regarding whole-body warming and cooling protocols used in emergency, athletic, and surgical scenarios. Furthermore, given the limited amount of thermoregulatory research that has included women, successful completion of this study could influence sex-specific practices for thermal safety.
Secondary aim: Investigate whether muscle temperature influences muscle blood flow, and consequently, post-exercise hypotension.
In addition to answering questions regarding thermoregulatory control, the present study-design's ability to independently alter muscle temperature from skin and core temperature can be used to answer question regarding the effect of local muscle temperature on blood flow. Elevated muscle temperature has been associated with changes in cardiovascular control and greater post exercise vasodilation in the previously active muscle. However, muscle is typically heated externally, which concomitantly alters skin temperature, which also has major effects on local and skin blood flow. Accordingly, the present methodology will allow us to alter muscle temperature while keeping core and skin temperature consistent between trials, allowing us to study the independent effect of muscle temperature on muscle blood flow. Moreover, the investigators believe this will be the first attempt to compare the effects of muscle temperature mediated differences in muscle blood flow between men and women.
Tertiary aim: Downhill running, of similar duration and intensity to the proposed downhill trial in this study (i.e. 60% of maximum oxygen uptake [VO2max], on a -10% decline, for 60 min), is regularly used to study exercise-induced muscle damage. Specifically, previous studies have employed men running for 40 min at 70% VO2max on a -10% decline, 30 min at 70% VO2max on a -15% decline, 60 min at 65% VO2max on a -10% decline, 60 min at 65% VO2max on a -10% decline, and women running for 60 min at 75% VO2max on a -10% decline. Of particular note, although downhill running-induced muscle damage has been studied in men and women, only one within-study sex comparison has been performed. In this study, where participants ran for 30 min at 70% of their VO2max on a -15% incline, it was observed that male participants had higher markers of exercise-induced muscle damage, compared to the female group, 24 h post-exercise. Also, of note, no studies to date have looked at the interactions between sex and incline (i.e. downhill vs flatland vs uphill) on muscle damage. Therefore, the investigators intend to take measures of muscle damage as the investigators are performing these incline running trials anyway.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Does muscle temperature influence heat loss responses independently from core and skin temperature? | Experimental | Procedure: Uphill running, Procedure: Flatland running, Procedure: Downhill runningThe 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? | Experimental | Procedure: Uphill running, Procedure: Flatland running, Procedure: Downhill runningFollowing 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? | Experimental | Procedure: Uphill running, Procedure: Flatland running, Procedure: Downhill runningFor 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Uphill runningParticipants will run at 70% of their maximal oxygen consumption for 60 min at a 10 degree (17.6%) incline. | Procedure or surgery | 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? |
| Flatland runningParticipants will run at 70% of their maximal oxygen consumption for 60 min at a 0 degree (0%) incline. | Procedure or surgery | 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? |
| Downhill runningParticipants will run at 70% of their maximal oxygen consumption for 60 min at a -10 degree (-17.6%) decline. | Procedure or surgery | 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? |
Primary outcome
Core temperature
Time frame: Immediately after completing the intervention
Measured by rectal and esophageal temperature
Skin temperature
Time frame: Immediately after completing the intervention
Measured at 8 sites using the ISO 9886 weighting system
Muscle temperature
Time frame: Immediately after completing the intervention
Measured at 4 locations: vastus lateralis, bicep femoris, lateral gastrocnemius and deltoid
Whole-body sweat rate (arm 1)
Time frame: Immediately after completing the intervention
Measured pre and post exercise with a platform scale (accurate to 1 g)
Femoral blood flow (arm 2)
Time frame: 1 hour after completing the intervention
Measured using Ultrasound Doppler
Blood pressure (arm 2)
Time frame: 1 hour after completing the intervention
Measured using a standard blood pressure cuff and finger photoplethysmography
Perceived muscle pain (arm 3)
Time frame: Assessed 48 hours after the completing exercise
Self-reported on a 100 mm likert scale ranging from "no pain or discomfort" to "maximal pain and discomfort"
Maximal voluntary contraction (arm 3)
Time frame: Assessed 48 hours after the completing exercise
The maximal force (in N) generated by the right leg during an isometric leg extension, with the knee at 90 degrees
Plasma creatinine levels (arm 3)
Time frame: Assessed 48 hours after the completing exercise
Measured from blood taken from an ante cubital vein
6 secondary outcomes
Oxygen consumption
Time frame: Average oxygen consumption over the 60 min of exercise
Local sweat rate
Time frame: Average local sweat rate over the 60 min of exercise
Skin blood flow
Time frame: Average skin blood flow over the 60 min of exercise
Heart rate
Time frame: Average heart rate over the 60 min of exercise
Perceived exertion
Time frame: Average perceived exertion over the 60 min of exercise
Thermal comfort
Time frame: Average thermal comfort over the 60 min of exercise
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2025.
- Individual participant dataSharing planned: Yes. 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan B Morris, PhD principal investigator
University of Colorado, Colorado Springs
Questions about this trial
What is this clinical trial studying?
A study testing Uphill running, Flatland running and Downhill running in people with Body Temperature Changes and Exercise, run by CommonSpirit Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Core temperature (time frame: Immediately after completing the intervention). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2025.