Skip to main content
OpenTrials
Completed

NCT Number: NCT05923125

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tisch Hospital

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Change in Circulating Level of SPMs

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Acronym: PERSPIRE

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jun 28, 2023
Registry last updated
Feb 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.