Exercise Testing for Cardiorespiratory Fitness Evaluation

(POPE Trial)

Overseen By Ashley Burke, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Duke University

Disqualifiers: Myocardial infarction, Angina, Hypertension, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

100 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will compare the measured oxygen consumption (VO2) obtained during sub-maximal exercise testing with the estimated VO2 derived from a non-exercise questionnaire.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Exercise, Physical Activity, Workout, Fitness Training?

Research shows that exercise programs are beneficial for patients with heart failure, improving their quality of life and being an essential part of cardiac rehabilitation. Additionally, exercise testing helps evaluate and improve cardiorespiratory fitness, which is important for managing cardiovascular and pulmonary diseases. ^{1 2 3 4 5}

Is exercise testing safe for humans?

Exercise testing is generally safe for humans, with a very low rate of adverse events. In a large study of over 50,000 tests, only three adverse events occurred, indicating a rate of 0.6 events per 10,000 tests. ^{6 7 8 9 10}

How is exercise testing for cardiorespiratory fitness different from other treatments?

Exercise testing is unique because it is a noninvasive method that evaluates cardiovascular function during physical activity, helping to tailor exercise programs for individual health needs. Unlike other treatments, it provides insights into both aerobic and anaerobic metabolism, which can guide personalized fitness and rehabilitation plans. ^{11 12 13 14 15}

Research Team

David MacLeod, FRCA

Principal Investigator

Duke University

Eligibility Criteria

This trial is for English-speaking adults who can walk (with or without help) and are patients at the Preoperative Anesthesia and Surgical Screening clinic with a low fitness score. They must be able to consent. Those with severe heart issues, very high blood pressure, recent heart attacks, or dementia cannot join.

Inclusion Criteria

Able to provide informed consent

I am 18 years old or older.

Preoperative Anesthesia and Surgical Screening (PASS) clinic patient with DASI score <34

Exclusion Criteria

Resting heart rate > 120 bpm

I had a heart attack 3 to 5 days ago.

Considered inappropriate to participate by Principal Investigator

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

1 visit (in-person)

Preoperative Assessment

Participants complete the Duke Activity Status Index (DASI) questionnaire and, if eligible, undergo a sub-maximal exercise test (6MST) to measure VO2.

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the preoperative assessment

1 week

Treatment Details

Interventions

• Exercise

Trial Overview The study aims to compare actual oxygen consumption measured during exercise with estimated values from a questionnaire in pre-surgery patients to see how well they match up.

Participant Groups

Group I: 6MST VO2 Active Control 1 Intervention

Completion of 6MST exercise protocol

Group II: DASI VO2 Active Control 1 Intervention

Completion of DASI fitness activity questionnaire

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Findings from Research

Cardiopulmonary exercise testing (CPET) has become a valuable tool in clinical practice for managing patients with cardiovascular and pulmonary diseases, providing precise measurements that help evaluate therapy responses and exercise intolerance.

Recent studies highlight the prognostic value of CPET, making it essential for tailoring exercise recommendations and supporting patients in engaging in exercise programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Applications of cardiopulmonary exercise testing in the management of cardiovascular and pulmonary disease. Myers, J.[2005]

Exercise training is a safe and effective treatment for patients with heart failure, significantly improving their quality of life and functioning, yet it is underutilized despite being a guideline-recommended intervention.

A tailored exercise program that considers individual patient preferences and physiological capabilities is crucial for success, highlighting the need to overcome barriers related to patient access, physician awareness, and insurance coverage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise And Heart Failure: Advancing Knowledge And Improving Care. Alvarez, P., Hannawi, B., Guha, A.[2018]

A study involving 40 prostate cancer patients demonstrated that the incremental cardiopulmonary exercise test (CPET) is highly reliable for measuring peak oxygen consumption (V˙O2peak) and other cardiovascular parameters, with correlation coefficients indicating strong consistency between tests.

Despite the high reliability, there was notable variability in the results, suggesting that while CPET is effective for assessing cardiorespiratory fitness, clinicians should be cautious in interpreting changes in fitness levels due to this variability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reliability of maximal cardiopulmonary exercise testing in men with prostate cancer. Scott, JM., Hornsby, WE., Lane, A., et al.[2022]

A patient with Spontaneous Coronary Artery Dissection underwent 21 sessions of cardiac rehabilitation, which led to significant improvements in aerobic capacity, flexibility, and grip strength.

The rehabilitation program helped maintain stable anthropometric values, indicating that physical exercise can be an effective complementary therapy alongside medication for cardiac patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Influence of cardiac rehabilitation in Primigravida with spontaneous coronary artery dissection during postpartum. Pinto, Mde C., Camargo, RC., Filho, JC., et al.[2021]

Cardiopulmonary exercise testing (CPET) is a valuable tool for assessing exercise intolerance and prognosis in patients with lung and heart diseases, using specific indices like peak oxygen uptake and lactate threshold to evaluate patient condition.

CPET can also effectively evaluate therapeutic interventions, with high-intensity constant-load exercise tests showing greater sensitivity to detect changes compared to traditional incremental tests, helping clinicians make informed decisions about patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations on the use of exercise testing in clinical practice. Palange, P., Ward, SA., Carlsen, KH., et al.[2019]

This extensive 18-year study involving 50,142 exercise tests in a clinical Chinese population found a very low rate of adverse events, at just 0.6 events per 10,000 tests, indicating that exercise testing is generally safe.

The study highlights that the majority of patients undergoing these tests had existing health conditions, yet the low incidence of serious adverse events suggests improvements in clinical practices over time have enhanced safety during exercise testing.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of Exercise Testing in the Clinical Chinese Population. Dun, Y., Olson, TP., Ripley-Gonzalez, JW., et al.[2021]

In a randomized controlled trial involving 209 elderly participants (average age 80), a home-based exercise program was found to be generally safe, with 151 adverse events reported, affecting 47% of participants.

Despite the program's safety, 14% of the adverse events were serious, highlighting that high levels of pre-existing morbidity in this population can pose challenges to maintaining consistent exercise participation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. Hinrichs, T., Bücker, B., Wilm, S., et al.[2015]

The study analyzed the training responsiveness of two cardiorespiratory fitness (CRF) interventions in 16 participants, revealing that a site-specific technical error (TE) of 7.7% for VO2max is more effective for assessing training outcomes than traditional criteria.

Training nonresponsiveness was observed in 11.5% to 34.6% of participants, highlighting the importance of using a tailored TE to better understand individual responses to CRF training interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using a site-specific technical error to establish training responsiveness: a preliminary explorative study. Weatherwax, RM., Harris, NK., Kilding, AE., et al.[2022]

Researchers in resistance training studies often lack clear guidance and motivation for thorough adverse event (AE) reporting, which can lead to inconsistent practices.

There is a need for exercise-specific guidelines for AE reporting, as current standards are perceived as not applicable to exercise trials, highlighting the importance of tailored strategies to improve reporting consistency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. El-Kotob, R., Pagcanlungan, JR., Craven, BC., et al.[2022]

A systematic review of 773 studies involving over 38,000 participants found that exercise therapy does not increase the risk of serious adverse events, indicating it is a safe intervention.

However, exercise therapy was associated with a higher risk of non-serious adverse events, with a relative risk of 1.19, meaning that for every 6 participants, one additional non-serious adverse event may occur.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. Niemeijer, A., Lund, H., Stafne, SN., et al.[2022]

Exercise testing, including lactate performance testing and cardiopulmonary exercise testing, is crucial for assessing the health and fitness of competitive athletes during annual medical check-ups.

These tests help determine individual endurance training intensities and maximum oxygen uptake, which are essential for optimizing training and managing athletes' exercise capacities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Exercise testing in top athletes]. Weichenberger, M., Esefeld, K., Müller, S.[2023]

Exercise testing is a crucial diagnostic tool in cardiology, widely used for screening coronary artery disease and assessing various heart conditions despite its low sensitivity and specificity.

It plays a significant role in imaging and cardiopulmonary exercise testing, helping to evaluate arrhythmias, hypertension, and congenital heart diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Ergometry - Step by Step]. Kenn, C., May, AE.[2018]

Exercise testing is a valuable noninvasive method for evaluating cardiovascular function both at rest and during physical activity, making it useful for assessing various cardiovascular disorders.

This method is also important for rehabilitation and training, helping individuals improve their physical activity performance safely.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exercise testing as a rehabilitative/training tool. Calzolari, A., Pastore, E.[2008]

The study developed new equations to estimate maximum oxygen uptake (VO2max) using data from 181 volunteers during treadmill exercise tests, which can provide a cost-effective alternative to expensive cardiopulmonary exercise testing devices.

Two specific equations were identified as highly accurate for estimating VO2max based on various factors like body mass, heart rate, and ventilation, improving the assessment of cardiorespiratory fitness for both active and sedentary individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prediction of maximum oxygen uptake through incremental exercise testing using ventilometry: a cross-sectional study. Policarpo Barbosa, F., Silva, PE., Guimarães, AC., et al.[2020]

Fitness testing effectively measures a person's aerobic capacity and identifies health risks, helping to tailor personalized exercise and diet plans for better health.

The study outlines the technology used in resting and exercise tests, along with recommended calculations and normal values to guide health assessments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Technology of fitness testing]. Apor, P.[2009]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Applications of cardiopulmonary exercise testing in the management of cardiovascular and pulmonary disease. [2005]

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

Exercise And Heart Failure: Advancing Knowledge And Improving Care. [2018]

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

Reliability of maximal cardiopulmonary exercise testing in men with prostate cancer. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Influence of cardiac rehabilitation in Primigravida with spontaneous coronary artery dissection during postpartum. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Recommendations on the use of exercise testing in clinical practice. [2019]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Safety of Exercise Testing in the Clinical Chinese Population. [2021]

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

Adverse events in mobility-limited and chronically ill elderly adults participating in an exercise intervention study supported by general practitioner practices. [2015]

8. New Zealand pubmed.ncbi.nlm.nih.gov

Using a site-specific technical error to establish training responsiveness: a preliminary explorative study. [2022]

9. Canada pubmed.ncbi.nlm.nih.gov

Researchers' perspectives on adverse event reporting in resistance training trials: a qualitative study. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Adverse events of exercise therapy in randomised controlled trials: a systematic review and meta-analysis. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

[Exercise testing in top athletes]. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

[Ergometry - Step by Step]. [2018]

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

Exercise testing as a rehabilitative/training tool. [2008]

14. Brazil pubmed.ncbi.nlm.nih.gov

Prediction of maximum oxygen uptake through incremental exercise testing using ventilometry: a cross-sectional study. [2020]

15. Hungary pubmed.ncbi.nlm.nih.gov

[Technology of fitness testing]. [2009]