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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03443193
Other study ID # MontrealHI 2015-1895
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 16, 2015
Est. completion date December 31, 2021

Study information

Verified date August 2022
Source Montreal Heart Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

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

Study Design


Intervention

Other:
Exercise training
Patients will undergo three weekly exercise training sessions with periodized high-intensity interval training and resistance training for a period of 12 weeks.

Locations

Country Name City State
Canada Cardiovascular prevention and rehabilitation center Montréal Quebec

Sponsors (1)

Lead Sponsor Collaborator
Montreal Heart Institute

Country where clinical trial is conducted

Canada, 

Outcome

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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