Pro-rEsolving and pRo-inflammatory reSPonses to Acute exhaustIve exeRcisE in Healthy Individuals

Not Applicable

Completed

• Conditions: Exercise
• Interventions: Behavioral: Graded-Intensity Treadmill Exercise Protocol

• Registration Number: NCT05923125
• Lead Sponsor: NYU Langone Health

Brief Summary

This is a study of the effects of acute, exhaustive exercise on pro-resolving and pro-inflammatory responses in healthy, trained and untrained adults.

Detailed Description

The study requires one visit (a second, optional visit may occur). At the visit, participants will have blood drawn at several time points and also perform an exhaustive bout of treadmill exercise. Differences in specialized pro-resolving lipid mediators (SPMs) and other measures of inflammation and resolution over time will be characterized.

Study Timeline

• Study First Submitted: 2023-06-20
• Study First Submitted QC: 2023-06-20
• Study First Posted: 2023-06-28
• Study Start: 2023-10-30
• Status Verified: 2024-09
• Primary Completion: 2025-01-29
• Study Completion: 2025-01-29
• Last Update Submitted: 2025-02-26
• Last Update Posted: 2025-02-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 103

Inclusion Criteria

• Willingness and ability to provide informed consent and participate in PRESPIRE
• Able to read and speak English adequately to provide informed consent and understand verbal and written instructions. (the diet and sleep questionnaires are not validated in languages other than English)
• BMI < 27kg/m2
• Untrained: self-reporting no more than 1 day per week of regular exercise (inclusive of walking >5,000 steps daily and commuting via bicycle).
• Trained: self-reporting at least 4 hours of aerobic exercise / moderate or greater intensity physical activity weekly for the past year.

Exclusion Criteria

• Anti-platelet medication use
• Chronic inflammatory or connective tissue disease
• History of bleeding or clotting disorder
• Immunological deficiency
• Diabetes mellitus
• Stage 2 or greater hypertension on screening
• Cardiovascular disease
• Chronic obstructive lung disease
• Anemia (hemoglobin <13g/dL in males or < 12 g/dL in females)
• Active smoking
• >5% body weight change over the past 6 months or plan to gain/lose weight during the study
• Platelet count <100,000
• Use of omega-3 fatty acid supplementation within 3 weeks of study participation
• Use of drugs or supplements known to inhibit COX-1/COX-2/lipoxygenases
• Corticosteroid use
• Use of beta-blocker medications
• Use of alpha-blocker medications
• Use of NSAIDs or aspirin within 2 weeks of study participation
• Vaccination within 2 weeks of study participation
• Pregnancy (a state of relative immunological deficiency)
• Any other cardiovascular, pulmonary, orthopedic, neurologic, psychiatric or other conditions that, in the opinion of the local clinician, would preclude participation and successful completion of the protocol.
• Any other illnesses that, in the opinion of the local clinician, would negatively impact or mitigate participation in and completion of the protocol

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Healthy Adults	Graded-Intensity Treadmill Exercise Protocol	Participants engage in a maximal exercise test. Before and after this test, blood samples are collected. At a separate, optional control visit, blood samples are collected as during the exercise visit, but participants do not participate in an exercise protocol.

Primary Outcome Measures

Name	Time	Method
Change in Circulating Level of SPMs	Pre-Exercise, 4.5 Hours Post-Exercise (Day 1)	Circulating level (%) of serum, plasma and neutrophil (SPMs) will be measured using patient blood draws.; Circulating level of SPMs is calculated as a composite endpoint.

Trial Locations

Locations (1)

Tisch Hospital; 🇺🇸 New York, New York, United States