ExercisePERSPIRENCT05923125
Pro-rEsolving and pRo-inflammatory reSPonses to Acute exhaustIve exeRcisE in Healthy Individuals
A study testing Graded-Intensity Treadmill Exercise Protocol in people with Exercise, run by NYU Langone Health at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Exercise
- What is being tested?
- Graded-Intensity Treadmill Exercise Protocol
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 103 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Oct 2023to 29 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Study of 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.
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.
- Conditions
- Exercise
- Being tested
- Graded-Intensity Treadmill Exercise Protocol
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Graded-Intensity Treadmill Exercise ProtocolBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Graded-Intensity Treadmill Exercise Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Pre-Exercise, 4.5 Hours Post-Exercise (Day 1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2023
- Study start30 Oct 2023
- Primary completion29 Jan 2025
- Study completion29 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ExerciseStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sean P. Heffron, MD, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05923125
- Sponsor's protocol ID
- 23-00421
- Acronym
- PERSPIRE
- Status last verified
- Sep 2024
- First submitted
- 20 Jun 2023
- Last updated
- 27 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data sharing will be considered, however the study team does not anticipate data will be made public outside of publication.
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Pro-rEsolving and pRo-inflammatory reSPonses to Acute exhaustIve exeRcisE in Healthy Individuals
- ClinicalTrials.gov ID
- NCT05923125
- Acronym / sponsor ID
- PERSPIRE / 23-00421
- Conditions
- Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Study start
- 30 Oct 2023 (actual)
- Primary completion
- 29 Jan 2025 (actual)
- Study completion
- 29 Jan 2025 (actual)
- First posted
- 28 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | Experimental | Behavioral: Graded-Intensity Treadmill Exercise ProtocolParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (22 listed)
- Anti-platelet medication use
- Chronic inflammatory or connective tissue disease
- History of bleeding or clotting disorder
- Immunological deficiency
- Diabetes mellitus
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Graded-Intensity Treadmill Exercise ProtocolThe 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. | Behavioural | Healthy Adults |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2025.
- Individual participant dataSharing planned: No. Data sharing will be considered, however the study team does not anticipate data will be made public outside of publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sean P. Heffron, MD principal investigator
NYU Langone Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Graded-Intensity Treadmill Exercise Protocol in people with Exercise, run by NYU Langone Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Circulating Level of SPMs (time frame: Pre-Exercise, 4.5 Hours Post-Exercise (Day 1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2025.