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

NCT05923125 | Completed

• 1 other identifier: 23-00421
• Study Type: interventional
• Target: 103
• Locations: 1 country
• Sites: 1

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.

Conditions

Exercise

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

Healthy Adults

EXPERIMENTAL

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

Interventions

Graded-Intensity Treadmill Exercise Protocol 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.

Healthy Adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

Tisch Hospital

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Sean P. Heffron, MD

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 20, 2023
• First Posted: June 28, 2023
• Study Start: October 30, 2023
• Primary Completion: January 29, 2025
• Study Completion: January 29, 2025
• Last Updated: February 27, 2025

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)