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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare two methods of measuring heart and lung function during exercise. One method uses a simple exercise test, while the other relies on a questionnaire about daily activities to estimate fitness. The goal is to determine if the questionnaire can reliably predict the same results as the exercise test. Ideal participants are those preparing for surgery, who can walk (even with assistance), speak English, and have specific pre-surgery clinic scores. As an unphased trial, this study offers participants the chance to contribute to research that may simplify fitness assessments for future patients.

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 prior data suggests that this exercise testing protocol is safe?

A previous study demonstrated that the 6-minute step test (6MST) is safe for healthy participants. This test involves stepping up and down on a 20-cm step for six minutes to assess aerobic fitness. Although it uses more energy than some other tests, it remains safe, even for those recovering from COVID-19.

Research has shown that the Duke Activity Status Index (DASI) is another safe option. It involves answering a questionnaire to estimate exercise ability. This method is simple and requires no physical activity, making it very low-risk.

Both the 6MST and DASI are well-accepted methods for measuring fitness. They have been used safely in numerous studies without reports of serious issues. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores innovative ways to evaluate cardiorespiratory fitness, which is crucial for understanding overall heart and lung health. While traditional methods often rely on expensive equipment and extensive testing, this trial is testing the 6-Minute Step Test (6MST) and the Duke Activity Status Index (DASI), both of which could offer more accessible and cost-effective alternatives. The 6MST measures fitness through a simple step exercise, and DASI uses a questionnaire to gauge physical activity levels, potentially allowing for broader, easier assessment across different populations. These methods might provide valuable insights into fitness levels without the need for complex setups, making them exciting prospects for both patients and healthcare providers.

What evidence suggests that this trial's methods could be effective for evaluating cardiorespiratory fitness?

This trial will compare two methods for evaluating cardiorespiratory fitness: the six-minute step test (6MST) and the Duke Activity Status Index (DASI). Research has shown that the 6MST effectively measures exercise capacity, especially in individuals with chronic obstructive pulmonary disease (COPD), as it predicts exercise ability and identifies those with lower tolerance. In contrast, the DASI is a questionnaire that estimates the ability to perform daily activities and is often used to assess heart health, providing a reliable picture of functional capacity without requiring physical exercise. Both methods measure fitness in slightly different ways, offering a more complete view of a person's health. ^{6 7 8 9 10}

Who Is on the Research Team?

David MacLeod, FRCA

Principal Investigator

Duke University

Are You a Good Fit for This Trial?

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

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

I can walk by myself or with help from devices.

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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]

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]

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]

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]

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]

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]

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]

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]

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 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]

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]

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]

Citations

1. atsjournals.org atsjournals.org/doi/full/10.1513/AnnalsATS.202206-516RL?role=tab

The Six-minute Step Test as an Exercise Outcome in ... After pulmonary rehabilitation, mean (standard deviation) 6MST increased from 56 (30) steps to 69 (28) steps, with a mean (95% confidence interval [CI]) change ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9496468/

Normative values and reference equation for the six-minute ... The mean number of steps climbed during the 6MST was 175 ± 45 (95%CI: 171-179). In general, the mean number of steps was 14% lower for women than for men, and ...

3. nature.com nature.com/articles/s41598-024-54338-9

The six-minute step test can predict COPD exacerbations The six-minute step test (6MST) has been shown to be effective in assessing exercise capacity in individuals with COPD regardless of severity.

4. jornaldepneumologia.com.br jornaldepneumologia.com.br/details/1342/en-US/responsiveness-of-the-six-minute-step-test-to-a-physical-training-program-in-patients-with-copd;

Responsiveness of the six-minute step test to a physical ... Data in the literature(21) have demonstrated that aerobic physical training results in an increase in the 6MWD and in improved exercise tolerance in patients ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4183495/

Validity of the six-minute step test of free cadence in ... The number of steps in 6MST was valid in assessing exercise capacity in patients with COPD and could identify patients with low exercise tolerance and poor ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9993159/

The Six-minute Step Test as an Exercise Outcome in ... The 6-minute step test (6MST) is a self-paced test using a 20-cm step platform, measuring the number of steps in 6 minutes, and is a simple ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8289340/

Reliability and validity of six-minute step test in patients ... The 6MST was a reliable and valid tool to assess functional capacity in HFrEF participants and may moderately predict peak workload and oxygen uptake of a CPET.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0031940615038602

Can we use the 6-minute step test instead of the 6- ... The 6MST and 6MWT are safe and produce submaximal effort in healthy participants. However, they are not interchangeable, and the 6MST requires more energy than ...

9. ijhsr.org ijhsr.org/IJHSR_Vol.13_Issue.11_Nov2023/IJHSR07.pdf

Normative Reference Values For 6 Minute Step Test in ... The 6-minute step test (6MST) is a self-paced test where participants climb a 20cm step as much as possible in 6 minutes, assessing aerobic capacity.

10. scielo.br scielo.br/j/fm/a/HJVcgMPJvSLSg8HNZ5mMzDB/

Step tests are feasible, safe, and can be used to evaluate ... This study showed that the 6MST and MIST are feasible and safe for assessing exercise capacity in individuals after hospitalization for COVID-19 in a home ...