Coronary Heart Disease Clinical Trial
— PERIODOfficial title:
The Effects of Periodization Training on Physiological Parameters, Cerebral Oxygenation, Cognitive Functions and Cardiac Remodelling in Coronary Patients.
Verified date | August 2022 |
Source | Montreal Heart Institute |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The research project includes two components that assess exercise physiology parameters, cerebrovascular reserve, cognitive functions and cardiac function in coronary heart disease patients at rest, during an acute exercise, and after two different periodized training programs.
Status | Completed |
Enrollment | 70 |
Est. completion date | December 31, 2021 |
Est. primary completion date | September 30, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria for patients with coronary heart disease: - Major - Adequate physical and mental capacities - Autonomy in daily activities - Documented coronary artery disease - Stable or recent coronary artery disease Exclusion Criteria for patients with coronary heart disease: - Inability to complete the consent form - Acute coronary syndrome < 3 months - Heart failure - Ejection fraction of the left ventricle <40% - Coronary artery disease non revascularisable including left main coronary stenosis - Waiting for a bridging of the coronary artery - Chronic atrial fibrillation - Malignant arrhythmias during exercise - Restriction to non cardiopulmonary exercise - Severe intolerance to exercise |
Country | Name | City | State |
---|---|---|---|
Canada | Cardiovascular prevention and rehabilitation center | Montréal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Montreal Heart Institute |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Maximal oxygen uptake (VO2peak) with gas exchange | VO2peak will be measured during maximal exercise test with a gas exchange device. The highest value reached during the exercise phase of the maximal test (ergocycle) will be considered as the VO2peak. We will measure change of VO2peak before and after exercise training. | At baseline and following 12 weeks exercise training intervention | |
Secondary | Cerebral hemodynamics | Cerebral hemodynamics will be measured using near-infrared spectroscopy (NIRS) system during maximal and submaximal exercise tests. We will measure change of cerebral hemodynamics before and after exercise training | At baseline and following 12 weeks exercise training intervention | |
Secondary | Cognitive functions at rest by a by standard pen-paper battery test | Cognitive functions will be measured at rest with a pen-paper battery test by a neuropsychologist. We will measure change of score to the cognitive tests before and after exercise training. | At baseline and following 12 weeks exercise training intervention | |
Secondary | Cardiac hemodynamics | Cardiac hemodynamics will be measured continuously during the maximal exercise test on bike using an impedance cardiography device. We will measure change of cardiac hemodynamics before and after exercise training. | At baseline and following 12 weeks exercise training intervention | |
Secondary | Standard echocardiographic parameter of left and right ventricular strain | global longitudinal strain (%) will be measued at rest for both ventricule | At baseline and following 12 weeks exercise training intervention |
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