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

NCT ID: NCT05923125

Last Updated: 2025-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 103 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-10-30
• Study Completion Date: 2025-01-29

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.

Conditions

Exercise

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Healthy Adults

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.

Group Type: EXPERIMENTAL

Graded-Intensity Treadmill Exercise Protocol

Intervention Type: BEHAVIORAL

The exercise protocol will be administered by the principal investigator or other trained study staff under the supervision of the PI in the stress testing laboratory of NYU Langone Health - Tisch Hospital. The exercise protocol duration will vary by participant, but is likely to be between 8 and 25 minutes in duration.

Interventions

Graded-Intensity Treadmill Exercise Protocol

The exercise protocol will be administered by the principal investigator or other trained study staff under the supervision of the PI in the stress testing laboratory of NYU Langone Health - Tisch Hospital. The exercise protocol duration will vary by participant, but is likely to be between 8 and 25 minutes in duration.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sean P. Heffron, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

Tisch Hospital

New York, New York, United States

Countries

United States

Other Identifiers

23-00421

Identifier Type: -

Identifier Source: org_study_id