CAD를 사용한 여성 및 남성을 위한 운동 테스트 프로토콜 (PACED)
CAD를 사용하여 여성과 남성을 위한 운동 테스트 프로토콜의 VO2 피크 값 비교
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:
- 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,
- if enjoyment affects the duration of the test, and
- how different exercise test protocols will provide different results of maximal oxygen used by the participant's body during the exercise test.
연구 개요
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Jennifer Reed, PhD
- 전화번호: 613-696-7392
- 이메일: jreed@ottawaheart.ca
연구 연락처 백업
- 이름: Matheus Mistura, MSc
- 전화번호: 15944 6136967000
- 이메일: mmistura@ottawaheart.ca
연구 장소
-
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Ontario
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Ottawa, Ontario, 캐나다, K1Y 4W7
- 모병
- University of Ottawa Heart Institute
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연락하다:
- Matheus Mistura, MSc
- 전화번호: 15944 6136967000
- 이메일: mmistura@ottawaheart.ca
-
연락하다:
- Jennifer Reed, PhD
- 전화번호: 6136967000
- 이메일: jreed@ottawaheart.ca
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
Adults older than 18 years of age and have been diagnosed with CAD.
설명
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: CASE_ONLY
- 시간 관점: PROSPECTIVE
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
Patients will complete 4 different cardiopulmonary exercise tests in random order. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Oxygen Consumption (VO2)
기간: 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)
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cardiometabolic health indicators - Blood pressure (BP)
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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)
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Jennifer Reed, PhD, Ottawa Heart Institute Research Corporation
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 20230327-01H
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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