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

Exercise Clinical Trial

— PERSPIRE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05923125
• Other study ID #: 23-00421
• Status: Recruiting
• Phase: N/A
• Start date: October 30, 2023
• Est. completion date: April 2024

Study information

• Verified date: November 2023
• Source: NYU Langone Health
• Contact: Sean P. Heffron, MD
• Phone: 212-263-6930
• Email: Sean.Heffron[@]nyulangone.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: April 2024
• Est. primary completion date: April 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Exercise

Intervention

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.

Locations

Country	Name	City	State
United States	Tisch Hospital	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
NYU Langone Health

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)