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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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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.

TRAVIS D GIBBONS, PhD contact

19282558769

travis.gibbons@nau.edu

United States1 site
  • Northern Arizona University

    Flagstaff, Arizona, 86011

    TRAVIS D GIBBONS, PhD, 9282558769, travis.gibbons@nau.edu

    RILEY CONNOR, MS

Other trials in United States

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.

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 groups in NCT07452094
Study groupRoleWhat they receive
Placebo-controlPlacebo comparatorExercise with saline injection
Receives: Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION
Group III/IV afferent blockadeExperimentalFeedback 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.

  1. Airway resistance

    Calculated based of work of breathing and ventilation flow rate

    Measured: 2 weeks

  2. Sweat rate

    Local eccrine sweat rates at 3 different sites

    Measured: 2 weeks

  3. 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.

  1. First posted5 Mar 2026
  2. Study start1 Apr 2026 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion1 Apr 2027 (estimated)

Resources

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)
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.

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.

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