40 Participants Needed

Talk Test for Coronary Heart Disease

(Talk-Test Trial)

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Overseen ByJennifer Reed, PhD
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Heart Institute Research Corporation
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help individuals exercise safely after heart procedures such as CABG (Coronary Artery Bypass Grafting) or PCI (Percutaneous Coronary Intervention). It compares two exercise program guidance methods: the Talk Test, where participants exercise until they can just comfortably talk, and CPET (Cardiopulmonary Exercise Test), a standard exercise test. The trial aims to determine if the Talk Test is as effective and safe as CPET when exercising at home with virtual monitoring. It seeks participants who underwent heart procedures 4 to 12 weeks ago, can handle a CPET, and have internet and smartphone access. As an unphased trial, it offers a unique opportunity to contribute to research that could enhance exercise safety and effectiveness for heart patients.

Do I have to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the Talk Test is safe for exercise prescription in coronary heart disease patients?

Research has shown that the Talk Test is a popular and straightforward method to determine the appropriate exercise intensity. It assesses how easily someone can speak while exercising. This method is favored for its simplicity and low cost and has proven reliable for individuals with heart conditions.

For the Cardiopulmonary Exercise Test (CPET), studies indicate it is generally safe. In a large study, major issues were rare, occurring in only 0.6% of tests. Minor issues occurred in 9.3% of tests, with no deaths or serious problems shortly after the test. CPET is a non-invasive test that evaluates heart and lung function during exercise.

Both methods have undergone testing and are considered safe. The Talk Test is easy to use, while CPET provides more detailed and valuable information.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it compares two innovative exercise-based methods for managing coronary heart disease. The Talk Test offers a simple, practical way to gauge exercise intensity by assessing a person's ability to talk during activity, making it accessible and easy to use without the need for specialized equipment. Meanwhile, the Cardiopulmonary Exercise Test (CPET) provides detailed physiological data to tailor exercise prescriptions, which can help optimize cardiac rehabilitation. By exploring these approaches, the trial aims to find more effective, personalized strategies for heart disease management, potentially improving outcomes and quality of life for patients.

What evidence suggests that this trial's treatments could be effective for coronary heart disease?

Research shows that the Talk Test, one method studied in this trial, safely and effectively guides exercise for people with heart disease. It is simple and affordable, requiring no special equipment. Studies indicate that people find it easy to use, and it helps regulate exercise intensity.

In contrast, the Cardiopulmonary Exercise Test (CPET), another method in this trial, offers a more detailed approach. It effectively identifies heart disease and assesses its severity. CPET provides specific information that can predict heart problems and aids in creating personalized exercise plans. Both methods offer valuable insights but approach exercise guidance differently.16789

Who Is on the Research Team?

AP

Andrew Pipe, MD

Principal Investigator

Ottawa Heart Institute Research Corporation

Are You a Good Fit for This Trial?

This trial is for individuals over 40 who've had a heart bypass or stent placement between 4 to 12 weeks ago. Participants need the ability to perform a CPET, have access to MyChart, email, internet, and a smartphone with fast internet. It's not for those unable to attend follow-ups, already in cardiac rehab programs, or with certain heart conditions like severe valve disease.

Inclusion Criteria

I had a heart procedure (PCI or CABG) between 4 and 12 weeks ago.
Patient has access to email and the internet
Patient has access to MyChart
See 3 more

Exclusion Criteria

Patient is currently participating in a virtual or on-site CR program
I have a serious heart or lung condition.
My heart pumps less blood than normal.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo virtual cardiac rehabilitation with exercise prescription based on either the Talk Test or CPET results

12 weeks
Virtual monitoring throughout

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • CPET
  • Talk Test
Trial Overview The study is testing if the 'Talk Test' can be as effective and safe as CPET (a type of exercise test) for prescribing home-based exercises after heart surgery. Patients will receive virtual monitoring during their rehabilitation program at home.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: Talk TestExperimental Treatment1 Intervention
Group II: Cardiopulmonary Exercise TestExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Heart Institute Research Corporation

Lead Sponsor

Trials
200
Recruited
95,800+

Citations

Diagnostic value of the cardiopulmonary exercise test in ...CPET is an effective non-invasive examination in the diagnosis of CHD, and has a certain clinical value in the evaluation of the severity of coronary artery ...
Cardiopulmonary Exercise Test Interpretation Across the ...Lower peak V ̇ o2, higher VE/Vco2 slope, and lower work rates predict a greater likelihood of worsening heart failure, arrhythmias, unplanned ...
Predictive Value of Cardiopulmonary Exercise Testing ...The purpose of present study is to investigate the correlation of CPET parameters in patients under PCI with high PP and assess their reference value for ...
Establishment and effectiveness evaluation of pre-test ...In this study, we propose to establish a pre-test probability model of CHD combined with CPET indexes, in order to compare the clinical ...
Cardiopulmonary exercise testing and efficacy of ...The aim of this analysis was to examine the relationship between CPET parameters, myocardial ischaemia and anginal symptoms in patients with ...
The Safety of Cardiopulmonary Exercise Testing in a ...This study investigates the safety of CPX in a heterogeneous cohort of patients with a wide variety of underlying high-risk cardiac diagnoses.
Cardiopulmonary Exercise Testing in Congenital Heart DiseaseConclusions: CPET is a powerful, non-invasive tool that should be integrated into routine management of CHD patients across all ages. It ...
Cardiopulmonary Exercise Testing in Congenital Heart ...CPET provides a reliable measure of exercise capacity that has significant prognostic ability in patients with CHD (Figure 2). Serial testing ...
Safety of cardiopulmonary exercise testing in a large ...A major event occurred in 56 (0.6%) tests and a minor event in 870 (9.3%) tests. There were no deaths within 48 hours, nor cardiac arrests ...
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