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Übungstestprotokolle für Frauen und Männer mit CAD (PACED)

30. September 2026 aktualisiert von: Ottawa Heart Institute Research Corporation

Vergleich der VO2-Spitzenwerte von Belastungstestprotokollen für Frauen und Männer mit 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

54

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

  • Kanada
    • Ontario
      • Ottawa, Ontario, Kanada, K1Y 4W7
        • Rekrutierung
        • University of Ottawa Heart Institute
        • Kontakt:
        • Kontakt:

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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

Beschreibung

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).

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: CASE_ONLY
  • Zeitperspektiven: PROSPECTIVE

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Diagnosetest: Exercise Tests

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Oxygen Consumption (VO2)
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Cardiometabolic health indicators - Blood pressure (BP)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Ottawa Heart Institute Research Corporation

Ermittler

  • Hauptermittler: Jennifer Reed, PhD, Ottawa Heart Institute Research Corporation

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. März 2024

Primärer Abschluss (Geschätzt)

1. Dezember 2028

Studienabschluss (Geschätzt)

1. Dezember 2030

Studienanmeldedaten

Zuerst eingereicht

11. Dezember 2023

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

11. Dezember 2023

Zuerst gepostet (Tatsächlich)

21. Dezember 2023

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

5. Oktober 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

30. September 2026

Zuletzt verifiziert

1. September 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 20230327-01H

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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