Placebo - ControlEarly Phase 1NCT07452094
What is the Role of Type III/IV Muscle Afferents in Airway Resistance and Thermoregulatory Responses to Exercise?
A Early Phase 1 study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Placebo - Control and Experimental, run by Northern Arizona University at 1 site in United States.
Trial summary
Exercise places serious demands on the body. These demands are fundamentally caused by increases in oxygen demand and the consequent increase in body temperature. These demands are met by several physiological responses, including increases in heart rate, blood pressure, breathing and blood flow. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Placebo - Control, Experimental
- What is being tested?
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Apr 2026to 1 Apr 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- regularly physically active as determined via questionnaires (Par-Q \& You)
- maximal aerobic power 30 mL/min/kg (female), 40 mL/kg/min (male)
Who cannot join
- current smokers
- acute bronchial asthma
- diabetics
- chronic back pain
- peripheral neuropathy
- chronic obstructive airway or status asthmaticus
Show all 16Show fewer
- obese (body mass index > 30 kg/m2)
- convulsive disorders
- requiring daily medications that may affect responses to exercise (e.g. anti-hypertensive, anti-arrhythmogenics, blood thinners)
- history of drug abuse
- history of disease/dysfunction that could cause complication with exercise (e.g. cardiovascular, respiratory, neurological, musculoskeletal)
- irregular or absent menstrual cycle
- pregnant or suspected pregnancy
- adverse response to physical exercise
- current or history of esophageal or gastric disease, or frequent heart burn (>2x per week)
- Lidocaine allergy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Northern Arizona University
Flagstaff, Arizona, 86011
TRAVIS D GIBBONS, PhD, 9282558769, travis.gibbons@nau.edu
RILEY CONNOR, MS
About this study
Official title: Type III/IV Muscle Afferents in Airway and Thermoregulatory Responses
Exercise places serious demands on the body. These demands are fundamentally caused by increases in oxygen demand and the consequent increase in body temperature. These demands are met by several physiological responses, including increases in heart rate, blood pressure, breathing and blood flow. These responses must be proportional to the increase in demand and some signal must relay information from the muscle to the brain. Group III/IV afferents do just this. They relay information about the muscle (movement, temperature, acidity, etc.) up to the brain so that appropriate responses are mounted. There is strong evidence in animals that group III/IV afferents play a key role in making breathing easier (decreasing airway resistance) and initiating sweating and blood flow responses. There has been no research on the role of group III/IV afferents on these fundamental exercise responses in humans. The investigators propose to isolate the role of group III/IV afferents on regulate airway resistance, sweating and blood flow responses to exercise in humans.
Read the detailed description
Group III/IV afferents are nerves that relay information from the muscles to the central nervous system. This afferent activity acts as negative feedback to minimize the overall strain placed on muscles . Without this negative feedback, locomotor muscles become damaged during intense exercise. It is well-established that group III/IV afferents are required for normal breathing and blood pressure responses to physical activity. In certain disease states, such as chronic obstructive pulmonary disease, heart failure and hypertension, group III/IV afferents become dysfunctional and lead to exercise intolerance. This is a major issue in these patient groups where regular exercise is advocated to slow or halt disease progression. Understanding how these reflexes contribute to basic cardiorespiratory responses to exercise is thus warranted.
At the onset of exercise, there is a near instantaneous decrease in airway resistance that permits high rates of breathing ; these high rates of breathing are essential to ensure appropriate oxygen transport to working muscles. The decrease in airway resistance is facilitated by a rapid withdrawal of parasympathetic tone to the smooth muscle lining the airways, allowing them to open up and remain rigid. Evidence in cats and dogs indicate that group III/IV afferents reflexively contribute to this response, thereby coupling airway dilation to muscle work. Airway resistance can be quantified by measuring the work required by breathing muscles to pull air into and push air out of the lungs. If the magnitude of airway dilation changes due to the suppression of group III/IV afferents, the investigators would observe a compensatory increase in how much work is required to overcome resistance. This has not been investigated directly in humans.
Alongside the fundamental cardiorespiratory responses to exercise, humans mount powerful thermoregulatory responses that dissipate heat generated from muscle work. The primary thermoregulatory responses in humans are eccrine sweating and skin vasodilation; both of which are activated as body temperature rises. Exercise augments thermoregulatory responses to heating, and sweating is initiated within 1-2 seconds of initiating exercise despite body temperature remaining stable. Thus, there is clearly a link between muscular work and thermoregulation. Reduced preparations in cats have shown that group III/IV afferent activity is elevated during external muscle heating, and human sweating responses are more closely coupled to muscle temperature than to core or skin temperature. To date, no study in humans has tried to isolate the role of group III/IV afferents on thermoregulatory responses to exercise.
These group III/IV afferents can be studied in exercising humans by suppressing their activity using intrathecal (spinal) opioids. Simply, a subject exercises on two different occasions, one with intact muscle reflex feedback, and the other with the feedback suppressed; differences in exercise responses are isolated to the role of group III/IV afferents. The investigators aim to use this model to quantify the contribution of group III/IV afferent reflexes to airway resistance, sweating and skin vasodilation.
- Conditions
- Placebo - Control, Experimental
- Being tested
- EXERCISE TRAINING WITH OR WITHOUT MEDICATION
- Keywords
- Group III/IV afferents, exercise, thermoregulation, sweating, blood flow, airway resistance
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EXERCISE TRAINING WITH OR WITHOUT MEDICATIONDrug
Cycling exercise with group III/IV afferent feedback blocked via drug
| Study group | Role | What they receive |
|---|---|---|
| Placebo-control | Placebo comparator | Exercise with saline injection Receives: Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
| Group III/IV afferent blockade | Experimental | Feedback from group III/IV afferents is blocked Receives: Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION |
What is being measured
The primary outcome is the main question the study is designed to answer.
Airway resistance
Calculated based of work of breathing and ventilation flow rate
Measured: 2 weeks
Sweat rate
Local eccrine sweat rates at 3 different sites
Measured: 2 weeks
Skin blood flow
Skin blood flux measured at different skin sites
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2026
- Study start1 Apr 2026 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placebo - ControlStudies 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
- Early Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Randomized order, repeated measures, cross-over
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northern Arizona University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- TRAVIS D GIBBONS, PhD, Principal investigator, Northern Arizona University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07452094
- Sponsor's protocol ID
- 2357749
- Status last verified
- Dec 2025
- First submitted
- 24 Dec 2025
- Last updated
- 5 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: I am concerned for privacy protection of our participants.
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Type III/IV Muscle Afferents in Airway and Thermoregulatory Responses
- ClinicalTrials.gov ID
- NCT07452094
- Acronym / sponsor ID
- 2357749
- Conditions
- Placebo - Control, Experimental
- Keywords
- Group III/IV afferents, exercise, thermoregulation, sweating, blood flow, airway resistance
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Northern Arizona UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Apr 2027 (estimated)
- First posted
- 5 Mar 2026 (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.
Exercise places serious demands on the body. These demands are fundamentally caused by increases in oxygen demand and the consequent increase in body temperature. These demands are met by several physiological responses, including increases in heart rate, blood pressure, breathing and blood flow. These responses must be proportional to the increase in demand and some signal must relay information from the muscle to the brain. Group III/IV afferents do just this. They relay information about the muscle (movement, temperature, acidity, etc.) up to the brain so that appropriate responses are mounted. There is strong evidence in animals that group III/IV afferents play a key role in making breathing easier (decreasing airway resistance) and initiating sweating and blood flow responses. There has been no research on the role of group III/IV afferents on these fundamental exercise responses in humans. The investigators propose to isolate the role of group III/IV afferents on regulate airway resistance, sweating and blood flow responses to exercise in humans.
Detailed description
Group III/IV afferents are nerves that relay information from the muscles to the central nervous system. This afferent activity acts as negative feedback to minimize the overall strain placed on muscles . Without this negative feedback, locomotor muscles become damaged during intense exercise. It is well-established that group III/IV afferents are required for normal breathing and blood pressure responses to physical activity. In certain disease states, such as chronic obstructive pulmonary disease, heart failure and hypertension, group III/IV afferents become dysfunctional and lead to exercise intolerance. This is a major issue in these patient groups where regular exercise is advocated to slow or halt disease progression. Understanding how these reflexes contribute to basic cardiorespiratory responses to exercise is thus warranted.
At the onset of exercise, there is a near instantaneous decrease in airway resistance that permits high rates of breathing ; these high rates of breathing are essential to ensure appropriate oxygen transport to working muscles. The decrease in airway resistance is facilitated by a rapid withdrawal of parasympathetic tone to the smooth muscle lining the airways, allowing them to open up and remain rigid. Evidence in cats and dogs indicate that group III/IV afferents reflexively contribute to this response, thereby coupling airway dilation to muscle work. Airway resistance can be quantified by measuring the work required by breathing muscles to pull air into and push air out of the lungs. If the magnitude of airway dilation changes due to the suppression of group III/IV afferents, the investigators would observe a compensatory increase in how much work is required to overcome resistance. This has not been investigated directly in humans.
Alongside the fundamental cardiorespiratory responses to exercise, humans mount powerful thermoregulatory responses that dissipate heat generated from muscle work. The primary thermoregulatory responses in humans are eccrine sweating and skin vasodilation; both of which are activated as body temperature rises. Exercise augments thermoregulatory responses to heating, and sweating is initiated within 1-2 seconds of initiating exercise despite body temperature remaining stable. Thus, there is clearly a link between muscular work and thermoregulation. Reduced preparations in cats have shown that group III/IV afferent activity is elevated during external muscle heating, and human sweating responses are more closely coupled to muscle temperature than to core or skin temperature. To date, no study in humans has tried to isolate the role of group III/IV afferents on thermoregulatory responses to exercise.
These group III/IV afferents can be studied in exercising humans by suppressing their activity using intrathecal (spinal) opioids. Simply, a subject exercises on two different occasions, one with intact muscle reflex feedback, and the other with the feedback suppressed; differences in exercise responses are isolated to the role of group III/IV afferents. The investigators aim to use this model to quantify the contribution of group III/IV afferent reflexes to airway resistance, sweating and skin vasodilation.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized order, repeated measures, cross-over
| Arm | Type | Receives |
|---|---|---|
| Placebo-control | Placebo comparator | Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONExercise with saline injection |
| Group III/IV afferent blockade | Experimental | Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATIONFeedback from group III/IV afferents is blocked |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- regularly physically active as determined via questionnaires (Par-Q \& You)
- maximal aerobic power 30 mL/min/kg (female), 40 mL/kg/min (male)
Key exclusion criteria (16 listed)
- current smokers
- acute bronchial asthma
- diabetics
- chronic back pain
- peripheral neuropathy
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 |
|---|---|---|
| EXERCISE TRAINING WITH OR WITHOUT MEDICATIONCycling exercise with group III/IV afferent feedback blocked via drug | Drug | Group III/IV afferent blockade, Placebo-control |
Primary outcome
Airway resistance
Time frame: 2 weeks
Calculated based of work of breathing and ventilation flow rate
Sweat rate
Time frame: 2 weeks
Local eccrine sweat rates at 3 different sites
Skin blood flow
Time frame: 2 weeks
Skin blood flux measured at different skin sites
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2026.
- Individual participant dataSharing planned: No. I am concerned for privacy protection of our participants.
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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.
TRAVIS D GIBBONS, PhD principal investigator
Northern Arizona University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing EXERCISE TRAINING WITH OR WITHOUT MEDICATION in people with Placebo - Control and Experimental, run by Northern Arizona University at 1 site in United States.
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 2 inclusion and 16 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: opening soon, as of the sponsor's last update on 5 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact TRAVIS D GIBBONS, PhD (19282558769, travis.gibbons@nau.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Airway resistance (time frame: 2 weeks). The study lists 3 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 5 Mar 2026.