CAD を使用した女性と男性の運動テスト プロトコル (PACED)
CADを使用した女性と男性の運動テストプロトコルのVO2ピーク値の比較
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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jennifer Reed, PhD
- 電話番号：613-696-7392
- メール：jreed@ottawaheart.ca
研究連絡先のバックアップ
- 名前：Matheus Mistura, MSc
- 電話番号：15944 6136967000
- メール：mmistura@ottawaheart.ca
研究場所
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Ontario
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Ottawa、Ontario、カナダ、K1Y 4W7
- 募集
- University of Ottawa Heart Institute
-
コンタクト：
- Matheus Mistura, MSc
- 電話番号：15944 6136967000
- メール：mmistura@ottawaheart.ca
-
コンタクト：
- Jennifer Reed, PhD
- 電話番号：6136967000
- メール：jreed@ottawaheart.ca
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Adults older than 18 years of age and have been diagnosed with CAD.
説明
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).
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_ONLY
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Oxygen Consumption (VO2)
時間枠：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)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Cardiometabolic health indicators - Blood pressure (BP)
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- 主任研究者：Jennifer Reed, PhD、Ottawa Heart Institute Research Corporation
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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