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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05923125
Acronym
PERSPIRE
Enrollment
103
Registered
2023-06-28
Start date
2023-10-30
Completion date
2025-01-29
Last updated
2025-02-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise

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.

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.

Sponsors

NYU Langone Health
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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

Design outcomes

Primary

MeasureTime frameDescription
Change in Circulating Level of SPMsPre-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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026