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Protocolos de pruebas de ejercicio para mujeres y hombres con CAD (PACED)

30 de septiembre de 2026 actualizado por: Ottawa Heart Institute Research Corporation

Comparación de los valores máximos de VO2 de los protocolos de pruebas de ejercicio para mujeres y hombres con CAD

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Tipo de estudio

De observación

Inscripción (Estimado)

54

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Jennifer Reed, PhD
  • Número de teléfono: 613-696-7392
  • Correo electrónico: jreed@ottawaheart.ca

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

  • Canadá
    • Ontario
      • Ottawa, Ontario, Canadá, K1Y 4W7
        • Reclutamiento
        • University of Ottawa Heart Institute
        • Contacto:
        • Contacto:

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra de probabilidad

Población de estudio

Adults older than 18 years of age and have been diagnosed with CAD.

Descripción

Inclusion Criteria:

  1. 18 years and older;
  2. previous CAD diagnosis by a physician;
  3. can perform a CPET until volitional exhaustion;
  4. are able to self-ambulate on a treadmill;
  5. are at least 8 weeks post cardiovascular event or procedure (i.e., percutaneous coronary intervention (PCI), coronary artery bypass graft (CABG)); and,
  6. are able to provide written informed consent.

Exclusion Criteria:

  1. cannot speak, read, write, or understand English or French;
  2. currently not enrolled in a CR program;
  3. 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);
  4. have heart failure with an ejection fraction <45% (indication of possible cardiomyopathy);6
  5. 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);
  6. has an ICD;
  7. is pregnant (sustained vigorous exercise in pregnant women may induce fetal bradycardia)
  8. is unable to complete submaximal exercise testing (i.e., treadmill, due to musculoskeletal limitations).

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: CASE_ONLY
  • Perspectivas temporales: PROSPECTIVE

Cohortes e Intervenciones

Grupo / Cohorte
Intervención / Tratamiento
CPETs

Patients will perform all 4 maximal cardiopulmonary exercise tests in randomized order. The protocols they will perform are: Modified Bruce, modified Naughton, modified Balke and the UOHI Slow Ramp.
Prueba de diagnóstico: Exercise Tests

Patients will complete 4 different cardiopulmonary exercise tests in random order.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Oxygen Consumption (VO2)
Periodo de tiempo: Week 1 to week 4 (measured weekly, at every appointment)

V̇O2 will be measured continuously throughout the treadmill CPET. Peak V̇O2, defined as the highest V̇O2 value that is achieved over a 20-s period during the last minute of the CPET. V̇O2 will be measured throughout each test by a metabolic system (Parvo Medics TrueOne 2400).
Week 1 to week 4 (measured weekly, at every appointment)

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Cardiometabolic health indicators - Blood pressure (BP)
Periodo de tiempo: Week 1 to week 4 (measured weekly, at every appointment)

Resting BP (mmHg) will be measured from a seated position using an automated BP monitor. BP will be measured manually using a BP cuff every 2 stages throughout the CPET using an automated BP monitor. Recovery BP will be measured after the completion of the test from a seated position using the automated BP monitor.
Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Heart Rate (HR)
Periodo de tiempo: Week 1 to week 4 (measured weekly, at every appointment)

Heart rate will be measured from a seated position using an automated BP monitor. HR will be measured continuously throughout the CPET using a 4-lead electrocardiogram connected to a metabolic system. Recovery HR will be measured after the completion of the test from a seated position using the automated BP monitor.
Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Body mass index
Periodo de tiempo: Week 1 to week 4 (measured weekly, at every appointment)

Height (cm) and body mass (kg) will be measured to compute body mass index (kg/m2).
Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Fat mass
Periodo de tiempo: Week 1 to week 4 (measured weekly, at every appointment)

Fat mass (kg) and fat-free mass (kg) will be measured using bioelectrical impedance.
Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Waist circumference
Periodo de tiempo: Week 1 to week 4 (measured weekly, at every appointment)

Waist circumference will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).
Week 1 to week 4 (measured weekly, at every appointment)
Cardiometabolic health indicators - Height
Periodo de tiempo: Week 1 to week 4 (measured weekly, at every appointment)

Height will be measured using standardized procedures (2 repeated measures using a tape; in centimeters).
Week 1 to week 4 (measured weekly, at every appointment)
Blood Lactate
Periodo de tiempo: Week 1 to week 4 (measured weekly, at every appointment)

Blood lactate (mmol/L) will be measured in the last 30s of every test stage throughout the test using a blood lactate analyzer.
Week 1 to week 4 (measured weekly, at every appointment)
Rating of perceived exertion (RPE)
Periodo de tiempo: Week 1 to week 4 (measured weekly, at every appointment)

Measured at the end of every stage using the validated Borg 6-20 rating of perceived exertion scale. This scale measures how physically exerted an individual feels. 6 is complete rest (i.e., no exertion, ex: sitting in a chair not moving and relaxed), 20 is perceived maximal exertion of effort. These values are perceived measures of effort and will increase as the exercise test progresses and gets harder for the patient.
Week 1 to week 4 (measured weekly, at every appointment)
Test duration
Periodo de tiempo: Week 1 to week 4 (measured weekly, at every appointment)

Measured using portable metabolic system that is connected to a computer. The duration of the test will be recorded.
Week 1 to week 4 (measured weekly, at every appointment)
Reason for test termination
Periodo de tiempo: Week 1 to week 4 (collected weekly, at every appointment)

Reason for test termination will be collected subjectively by asking the patient (i.e., fatigue, muscular limitation, etc.)
Week 1 to week 4 (collected weekly, at every appointment)
Physical activity enjoyment
Periodo de tiempo: Week 1 to week 4 (collected weekly, at every appointment)

This is a subjective questionnaire that measures the extent to which the patient enjoyed participating in the test.
Week 1 to week 4 (collected weekly, at every appointment)
Most enjoyed test
Periodo de tiempo: Week 4 - collected at the patient's last appointment

Using a feedback questionnaire, the test that was most frequently ranked the most enjoyed by patients will be measured
Week 4 - collected at the patient's last appointment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Ottawa Heart Institute Research Corporation

Investigadores

  • Investigador principal: Jennifer Reed, PhD, Ottawa Heart Institute Research Corporation

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

1 de marzo de 2024

Finalización primaria (Estimado)

1 de diciembre de 2028

Finalización del estudio (Estimado)

1 de diciembre de 2030

Fechas de registro del estudio

Enviado por primera vez

11 de diciembre de 2023

Primero enviado que cumplió con los criterios de control de calidad

11 de diciembre de 2023

Publicado por primera vez (Actual)

21 de diciembre de 2023

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

30 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 20230327-01H

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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