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CompletedNCT05923125PERSPIREUpdated Feb 27, 2025

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

An interventional study of Graded-Intensity Treadmill Exercise Protocol in Exercise, sponsored by NYU Langone Health. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-02-27.

Sponsored by NYU Langone Health · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
103
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Exercise
03

In context

Lead sponsor

NYU Langone Health is the lead sponsor of 1,391 studies on the registry; 254 are open to participants now.

Of its 227 completed or terminated interventional studies of FDA-regulated products, 191 (84%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
103 participants (actual)

Study arms

  • 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

Interventions

  • BehavioralGraded-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.

06

What researchers measure

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.

    Time frame: Pre-Exercise, 4.5 Hours Post-Exercise (Day 1)

07

Study locations

1 site
  • Tisch Hospital
    New York, New York 10016, United States
08

References and documents

Individual participant data

Plan to share: No — Data sharing will be considered, however the study team does not anticipate data will be made public outside of publication.

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 27, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05923125
Lead sponsor
NYU Langone Health
Responsible party
Sponsor
First posted
Jun 28, 2023
Start date
Oct 30, 2023
Primary completion
Jan 29, 2025
Completion
Jan 29, 2025
Last update
Feb 27, 2025

Study contacts

Sean P. Heffron, MD
principal investigator · NYU Langone Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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