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Идёт набор NCT06179212

Exercise Testing Protocols for Females and Males With CAD

— Наблюдательное Coronary Artery Disease

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Exercise Tests.
Кому может быть актуально
Состояния в реестре: Coronary Artery Disease. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Канада
Следующий шаг
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Официальное название

Comparing VO2 Peak Values of Exercise Testing Protocols for Females and Males With CAD

Обзор

The aim of this study is to determine if the test that allows males to achieve a higher VO2 (a measure of oxygen use during exercise) is different for females. The purpose of this study is to test 4 different exercise testing protocols to compare measured oxygen consumption in females and males with CAD (disease caused by the buildup of plaque in the artery walls which can lead to insufficient amounts of blood, nutrients and oxygen being supplied to the heart). The 4 exercise tests that will be completed on the treadmill are the modified Balke, modified Bruce, modified Naughton and University of Ottawa Heart Institute Slow Ramp protocols. Each test has a different stage duration (the amount of time that the test remains at a pre-determined speed and incline), and incremental increase in speed and incline. The main purpose of this study is to compare VO2 peak (the maximal amount of oxygen utilized during the exercise test) of females and males with CAD in 4 different exercise protocols. For example, the investigators will find out: 1. which exercise protocol is more likely to achieve a higher peak V̇O2 in females and which protocol is more likely to achieve a higher peak V̇O2 in males, 2. if enjoyment affects the duration of the test, and 3. how different exercise test protocols will provide different results of maximal oxygen used by the participant's body during the exercise test.

Вмешательства

  • Диагностический тест Exercise Tests
    Patients will complete 4 different cardiopulmonary exercise tests in random order.

Первичные конечные точки

  • Oxygen Consumption (VO2) [Срок оценки: Week 1 to week 4 (measured weekly, at every appointment)]
Вторичные конечные точки (12)
  • Cardiometabolic health indicators - Blood pressure (BP) [Срок оценки: Week 1 to week 4 (measured weekly, at every appointment)]
  • Cardiometabolic health indicators - Heart Rate (HR) [Срок оценки: Week 1 to week 4 (measured weekly, at every appointment)]
  • Cardiometabolic health indicators - Body mass index [Срок оценки: Week 1 to week 4 (measured weekly, at every appointment)]
  • Cardiometabolic health indicators - Fat mass [Срок оценки: Week 1 to week 4 (measured weekly, at every appointment)]
  • Cardiometabolic health indicators - Waist circumference [Срок оценки: Week 1 to week 4 (measured weekly, at every appointment)]
  • Cardiometabolic health indicators - Height [Срок оценки: Week 1 to week 4 (measured weekly, at every appointment)]
  • Blood Lactate [Срок оценки: Week 1 to week 4 (measured weekly, at every appointment)]
  • Rating of perceived exertion (RPE) [Срок оценки: Week 1 to week 4 (measured weekly, at every appointment)]
  • Test duration [Срок оценки: Week 1 to week 4 (measured weekly, at every appointment)]
  • Reason for test termination [Срок оценки: Week 1 to week 4 (collected weekly, at every appointment)]
  • Physical activity enjoyment [Срок оценки: Week 1 to week 4 (collected weekly, at every appointment)]
  • Most enjoyed test [Срок оценки: Week 4 - collected at the patient's last appointment]

Критерии участия

Критерии включения

  • 18 years and older;
  • previous CAD diagnosis by a physician;
  • can perform a CPET until volitional exhaustion;
  • are able to self-ambulate on a treadmill;
  • are at least 8 weeks post cardiovascular event or procedure (i.e., percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)); and,
  • are able to provide written informed consent.

Критерии исключения

  • cannot speak, read, write, or understand English or French;
  • currently not enrolled in a CR program;
  • have recently changed (or planning to change) PA levels within the previous 4 weeks (as this may impact the ability to compare outcomes between exercise testing protocols);
  • have heart failure with an ejection fraction <45% (indication of possible cardiomyopathy);6
  • have an arrythmia (relative contraindication for exercise testing),6 peripheral artery disease, valvular disease, severe aortic stenosis, cardiomyopathy, SCAD and/or COPD (contraindications for maximal exercise testing);
  • has an ICD;
  • is pregnant (sustained vigorous exercise in pregnant women may induce fetal bradycardia)
  • is unable to complete submaximal exercise testing (i.e., treadmill, due to musculoskeletal limitations).

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Канада · 1 центр
  • University of Ottawa Heart Institute — Ottawa

Идентификаторы

NCT: NCT06179212 · 20230327-01H

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗