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

A Pilot Study of Pro-rEsolving and pRo-inflammatory reSPonses to Acute exhaustIve exeRcisE in Healthy Individuals

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

Study Overview

• Status: Completed
• Conditions: Exercise
• Intervention / Treatment: Behavioral: Graded-Intensity Treadmill Exercise Protocol

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 Type: Interventional
• Enrollment (Actual): 103
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • Tisch Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Circulating Level of SPMs	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.	Pre-Exercise, 4.5 Hours Post-Exercise (Day 1)

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Sean P. Heffron, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2023
• Primary Completion (Actual): January 29, 2025
• Study Completion (Actual): January 29, 2025

Study Registration Dates

• First Submitted: June 20, 2023
• First Submitted That Met QC Criteria: June 20, 2023
• First Posted (Actual): June 28, 2023

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: February 26, 2025
• Last Verified: September 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 23-00421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Data sharing will be considered, however the study team does not anticipate data will be made public outside of publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No