Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 5:22 AM
Study NCT ID:
NCT07452094
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-05
First Post:
2025-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
What is the Role of Type III/IV Muscle Afferents in Airway Resistance and Thermoregulatory Responses to Exercise?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D004304', 'term': 'Dosage Forms'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D013678', 'term': 'Technology, Pharmaceutical'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participant will be blinded to condition. Researcher will be blinded to condition. Researcher will be masked to data during analysis.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized order, repeated measures, cross-over'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 15}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2027-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-27', 'studyFirstSubmitDate': '2025-12-24', 'studyFirstSubmitQcDate': '2026-02-27', 'lastUpdatePostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Airway resistance', 'timeFrame': '2 weeks', 'description': 'Calculated based of work of breathing and ventilation flow rate'}, {'measure': 'Sweat rate', 'timeFrame': '2 weeks', 'description': 'Local eccrine sweat rates at 3 different sites'}, {'measure': 'Skin blood flow', 'timeFrame': '2 weeks', 'description': 'Skin blood flux measured at different skin sites'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Group III/IV afferents', 'exercise', 'thermoregulation', 'sweating', 'blood flow', 'airway resistance'], 'conditions': ['Placebo - Control', 'Experimental']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nAt 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.\n\nAlongside 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.\n\nThese 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* regularly physically active as determined via questionnaires (Par-Q \\& You)\n* maximal aerobic power 30 mL/min/kg (female), 40 mL/kg/min (male)\n\nExclusion Criteria:\n\n* current smokers\n* acute bronchial asthma\n* diabetics\n* chronic back pain\n* peripheral neuropathy\n* chronic obstructive airway or status asthmaticus\n* obese (body mass index \\> 30 kg/m2)\n* convulsive disorders\n* requiring daily medications that may affect responses to exercise (e.g. anti-hypertensive, anti-arrhythmogenics, blood thinners)\n* history of drug abuse\n* history of disease/dysfunction that could cause complication with exercise (e.g. cardiovascular, respiratory, neurological, musculoskeletal)\n* irregular or absent menstrual cycle\n* pregnant or suspected pregnancy\n* adverse response to physical exercise\n* current or history of esophageal or gastric disease, or frequent heart burn (\\>2x per week)\n* Lidocaine allergy'}, 'identificationModule': {'nctId': 'NCT07452094', 'briefTitle': 'What is the Role of Type III/IV Muscle Afferents in Airway Resistance and Thermoregulatory Responses to Exercise?', 'organization': {'class': 'OTHER', 'fullName': 'Northern Arizona University'}, 'officialTitle': 'Type III/IV Muscle Afferents in Airway and Thermoregulatory Responses', 'orgStudyIdInfo': {'id': '2357749'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo-control', 'description': 'Exercise with saline injection', 'interventionNames': ['Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION']}, {'type': 'EXPERIMENTAL', 'label': 'Group III/IV afferent blockade', 'description': 'Feedback from group III/IV afferents is blocked', 'interventionNames': ['Drug: EXERCISE TRAINING WITH OR WITHOUT MEDICATION']}], 'interventions': [{'name': 'EXERCISE TRAINING WITH OR WITHOUT MEDICATION', 'type': 'DRUG', 'description': 'Cycling exercise with group III/IV afferent feedback blocked via drug', 'armGroupLabels': ['Group III/IV afferent blockade', 'Placebo-control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '86011', 'city': 'Flagstaff', 'state': 'Arizona', 'country': 'United States', 'contacts': [{'name': 'TRAVIS D GIBBONS, PhD', 'role': 'CONTACT', 'email': 'travis.gibbons@nau.edu', 'phone': '9282558769'}, {'name': 'RILEY CONNOR, MS', 'role': 'SUB_INVESTIGATOR'}, {'name': 'TRAVIS D GIBBONS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Northern Arizona University', 'geoPoint': {'lat': 35.19807, 'lon': -111.65127}}], 'centralContacts': [{'name': 'TRAVIS D GIBBONS, PhD', 'role': 'CONTACT', 'email': 'travis.gibbons@nau.edu', 'phone': '19282558769'}], 'overallOfficials': [{'name': 'TRAVIS D GIBBONS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Northern Arizona University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'I am concerned for privacy protection of our participants.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northern Arizona University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}