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Træningstestprotokoller for kvinder og mænd med CAD (PACED)

30. september 2026 opdateret af: Ottawa Heart Institute Research Corporation

Sammenligning af VO2-spidsværdier for træningstestprotokoller for kvinder og mænd med 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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Anslået)

54

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Undersøgelse Kontakt Backup

Studiesteder

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1Y 4W7
        • Rekruttering
        • University of Ottawa Heart Institute
        • Kontakt:
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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

Beskrivelse

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).

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: CASE_ONLY
  • Tidsperspektiver: PROSPECTIVE

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
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.
Diagnostisk test: Exercise Tests

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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Oxygen Consumption (VO2)
Tidsramme: 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)

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Cardiometabolic health indicators - Blood pressure (BP)
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ottawa Heart Institute Research Corporation

Efterforskere

  • Ledende efterforsker: Jennifer Reed, PhD, Ottawa Heart Institute Research Corporation

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

1. marts 2024

Primær færdiggørelse (Anslået)

1. december 2028

Studieafslutning (Anslået)

1. december 2030

Datoer for studieregistrering

Først indsendt

11. december 2023

Først indsendt, der opfyldte QC-kriterier

11. december 2023

Først opslået (Faktiske)

21. december 2023

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 20230327-01H

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