Graded-Intensity Treadmill Exercise for Exercise Response

(PERSPIRE Trial)

Overseen By Lina Rosario

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Antiplatelets, Corticosteroids, NSAIDs, others

Disqualifiers: Diabetes, Hypertension, Cardiovascular, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how intense treadmill exercise affects inflammation and recovery in both active and less-active adults. Participants undergo a challenging treadmill test, the Graded-Intensity Treadmill Exercise Protocol, with blood samples taken before and after to measure changes. Ideal participants are healthy adults who either exercise regularly or rarely, but do not take certain medications or have specific health issues. As an unphased study, this trial offers a unique opportunity to contribute to scientific understanding of exercise's impact on health.

Do I need to stop taking my current medications to join the trial?

Yes, you may need to stop taking certain medications. The trial excludes participants using anti-platelet medications, omega-3 supplements within 3 weeks, drugs or supplements that inhibit COX-1/COX-2/lipoxygenases, corticosteroids, beta-blockers, alpha-blockers, NSAIDs, or aspirin within 2 weeks. Check with the trial team for specific guidance.

What prior data suggests that this Graded-Intensity Treadmill Exercise Protocol is safe for healthy adults?

Research has shown that the graded-intensity treadmill exercise protocol, such as the Bruce protocol, is commonly used in exercise stress tests. These methods have existed for many years and are considered safe for most people. They gradually increase exercise intensity to assess the body's response.

Studies have found that most people handle these exercise tests well. Serious issues rarely occur, but participants might experience tiredness or slight muscle soreness. These are normal reactions, especially for those unaccustomed to intense exercise.

In summary, the graded-intensity treadmill exercise protocol is a widely used and safe method to test how healthy adults respond to exercise. It is designed to minimize risks while effectively measuring the body's reaction to more challenging physical activity. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the graded-intensity treadmill exercise protocol because it explores how varying exercise intensities impact the body's physiological response, which isn't typically the focus of standard fitness regimens. Unlike traditional exercise plans that often emphasize a consistent pace or intensity, this approach adjusts intensity levels, potentially offering insights into optimizing cardiovascular and metabolic health. By studying blood samples before and after exercise, scientists hope to uncover new data on how the body adapts to different exercise intensities, ultimately leading to more personalized and effective exercise recommendations.

What evidence suggests that the Graded-Intensity Treadmill Exercise Protocol is effective for exercise response?

Research shows that a treadmill exercise test, such as the Bruce protocol, commonly assesses heart and lung performance. This test begins at an easy level and gradually becomes more challenging by increasing speed and incline. Studies have found it effectively measures exercise capacity and the body's response to intense activity, with reliable and consistent results. The trial will use the Graded-Intensity Treadmill Exercise Protocol to understand how different people react to exercise stress, providing insights into the body's handling of inflammation and recovery. ^{1 2 4 5 6}

Who Is on the Research Team?

Sean Heffron, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

This trial is for healthy adults who can understand English and are willing to participate. It includes those with a BMI under 27, divided into two groups: untrained individuals exercising no more than once a week, and trained ones doing at least four hours of aerobic exercise weekly for the past year.

Inclusion Criteria

Untrained: self-reporting no more than 1 day per week of regular exercise (inclusive of walking >5,000 steps daily and commuting via bicycle)

BMI < 27kg/m2

I am willing and able to agree to participate in the PRESPIRE study.

Exclusion Criteria

Active smoking

I have a long-term inflammatory or connective tissue condition.

I am taking medication to prevent blood clots.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Exercise Visit

Participants perform an exhaustive bout of treadmill exercise and have blood drawn at several time points

1 day

1 visit (in-person)

Optional Control Visit

Participants have blood drawn without participating in an exercise protocol

1 day

1 optional visit (in-person)

Follow-up

Participants are monitored for changes in circulating levels of SPMs post-exercise

4.5 hours

What Are the Treatments Tested in This Trial?

Interventions

• Graded-Intensity Treadmill Exercise Protocol

Trial Overview The study investigates how an acute session of exhaustive treadmill exercise affects inflammation and healing responses in the body. Participants will undergo a graded-intensity workout on a treadmill to test these effects.

How Is the Trial Designed?

Group I: Healthy Adults Experimental Treatment 1 Intervention

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.

Graded-Intensity Treadmill Exercise Protocol is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Graded Exercise Testing for:

• Diagnosis and prognosis of coronary artery disease
• Assessment of chronotropic competence
• Evaluation of exercise-induced symptoms
• Evaluation of unexplained syncope in patients at intermediate to high risk of CAD

Approved in European Union as Treadmill Stress Testing for:

• Diagnosis and prognosis of coronary artery disease
• Assessment of exercise capacity and need for surgical intervention in valvular heart disease

Approved in Canada as Graded Exercise Testing for:

• Detection of CAD in patients with chest pain or dyspnea on exertion who are at intermediate risk of acute coronary syndrome

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Published Research Related to This Trial

Graded exercise tests are essential for determining safe exercise levels for cardiac patients, as they provide critical information on heart rate and electrocardiographic responses during exercise.

The mode of testing influences the responses observed, which helps healthcare providers tailor exercise prescriptions for effective cardiac rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing in cardiac rehabilitation. Role in prescribing exercise. Graves, JE., Pollock, ML.[2007]

The BSU/Bruce Ramp protocol, tested on 698 participants, effectively predicts peak oxygen uptake (VO2peak) during treadmill exercise, with maximal test time being the strongest predictor, explaining 86% of the variance.

Incorporating additional factors like age, gender, physical activity habits, and body weight slightly improved prediction accuracy, making the BSU/Bruce Ramp protocol a reliable option for exercise testing in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of a new standardized ramp protocol: the BSU/Bruce Ramp protocol. Kaminsky, LA., Whaley, MH.[2022]

A new treadmill protocol was developed and tested on 22 elite Saudi athletes (11 triathletes and 11 soccer players) to assess maximal fitness levels while ensuring patient comfort and safety during exercise.

This modified protocol allows for achieving high peak oxygen consumption (VO2max) with reduced cardiovascular stress compared to traditional methods, making it a practical alternative for both testing and training.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardio respiratory response: Validation of new modifications of Bruce protocol for exercise testing and training in elite Saudi triathlon and soccer players. Badawy, MM., Muaidi, QI.[2022]

This study established new reference values for the original Bruce treadmill protocol in 78 healthy Dutch children aged 4 and 5 years, showing a mean endurance time of 10.2 minutes.

The original Bruce protocol yielded significantly longer endurance times compared to the 'half Bruce' protocol, with a mean difference of 50 seconds, indicating that these two protocols are not interchangeable for assessing exercise capacity in young children.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing of pre-school children using the Bruce treadmill protocol: new reference values. van der Cammen-van Zijp, MH., Ijsselstijn, H., Takken, T., et al.[2021]

The British Columbia Children's Hospital (BCCH) exercise protocol yields similar peak physiological responses (like oxygen consumption and ventilation) compared to the traditional Bruce protocol in a study of 70 children aged 10-18 years.

The BCCH protocol allows for longer total exercise time, making it a potentially more practical and effective option for clinical exercise testing in pediatric populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel treadmill protocol for exercise testing in children: the British Columbia Children's Hospital protocol. Duff, DK., De Souza, AM., Human, DG., et al.[2023]

The ramped Bruce protocol allows for longer test durations and higher metabolic equivalents (METs) compared to the standard Bruce protocol, making it a more effective option for stress testing in patients.

Patients reported significantly greater comfort and ease with the ramped protocol, indicating a preference for this method while achieving similar hemodynamic responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing: improving performance with a ramped Bruce protocol. Will, PM., Walter, JD.[2022]

Citations

1. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK499903/

Treadmill Stress Testing - StatPearls - NCBI Bookshelf The Bruce protocol is the most common one used during treadmill exercise stress testing. [15] This protocol is divided into successive 3-minute stages, each ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5221270/

Graded Exercise Testing Protocols for the Determination of ... The Balke protocol maintains a constant speed (3.3 mph) but increases grade by 1% each minute. The Bruce protocol increases speed and grade every 3 min. The ...

3. ahajournals.org ahajournals.org/doi/10.1161/cir.0b013e31829b5b44

Exercise Standards for Testing and Training | Circulation Protocols for clinical exercise testing generally include an initial warm-up period (at low workload), followed by progressive graded exercise with increasing ...

4. aafp.org aafp.org/pubs/afp/issues/2017/0901/p293.html

Exercise Stress Testing: Indications and Common Questions The standard Bruce protocol is preferred for exercise stress testing (eTable A). Its outcomes are well validated, and exercise capacity measured ...

5. vo2master.com vo2master.com/blog/bruce-protocol-testing-vo2-master/?srsltid=AfmBOoo2LT5CTjivXs6putLzPl9seAEKQTnBkbw6zhiX5boBFUHxmUkI

Bruce Protocol Testing Simplified The Bruce protocol is a widely respected graded exercise test designed to assess cardiovascular performance on a treadmill.

6. verywellfit.com verywellfit.com/the-bruce-treadmill-test-protocol-3120269

Bruce Protocol Treadmill Test | Measuring VO2 Max The Bruce protocol treadmill test was designed by cardiologist Robert A. Bruce in 1963 as a non-invasive test to assess patients with suspected heart disease.