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

103 Participants Needed

Trial Summary

What is the purpose of this trial?

This is a study of the effects of acute, exhaustive exercise on pro-resolving and pro-inflammatory responses in healthy, trained and untrained adults.

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 data supports the idea that Graded-Intensity Treadmill Exercise for Exercise Response is an effective treatment?

The available research shows that the Bruce protocol, a type of Graded-Intensity Treadmill Exercise, is widely used and effective for assessing fitness levels. It has been adapted for different populations, such as elite athletes and children, to improve comfort and safety while still achieving similar fitness outcomes. For example, a study on children using the Bruce protocol found it effective in measuring exercise capacity, with new reference values established for young children. These adaptations and validations suggest that the treatment is effective across various groups. ^{1 2 3 4 5}

What safety data exists for graded-intensity treadmill exercise protocols?

The safety of graded-intensity treadmill exercise protocols, including the Bruce and its modifications, has been evaluated in various studies. These protocols are widely used in clinical settings for exercise testing. Modifications like the ramped Bruce protocol and others have been developed to improve patient comfort and safety, especially in specific populations like children and athletes. The studies suggest that these protocols are generally safe when conducted under appropriate conditions and with proper supervision. ^{1 2 3 4 5}

Is the Graded-Intensity Treadmill Exercise Protocol a promising treatment?

Yes, the Graded-Intensity Treadmill Exercise Protocol is promising because it helps predict peak oxygen uptake, improves fitness levels, and is useful for exercise prescription in cardiac rehabilitation. ^{1 2 3 5 6}

Research Team

Sean Heffron, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Evaluation of a new standardized ramp protocol: the BSU/Bruce Ramp protocol. [2022]

2. Saudi Arabia 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. [2022]

3. England pubmed.ncbi.nlm.nih.gov

A novel treadmill protocol for exercise testing in children: the British Columbia Children's Hospital protocol. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Exercise testing: improving performance with a ramped Bruce protocol. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Exercise testing of pre-school children using the Bruce treadmill protocol: new reference values. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

Exercise testing in cardiac rehabilitation. Role in prescribing exercise. [2007]