Periodization of Exercise Training in Patients With Coronary Heart Disease.

Coronary Heart Disease Clinical Trial

— PERIOD  

Official title:

The Effects of Periodization Training on Physiological Parameters, Cerebral Oxygenation, Cognitive Functions and Cardiac Remodelling in Coronary Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443193
• Other study ID #: MontrealHI 2015-1895
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Coronary Heart Disease
• Healthy Control
• Heart Diseases
• Myocardial Ischemia

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