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Periodization of Exercise Training in Patients With Coronary Heart Disease. (PERIOD)

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ClinicalTrials.gov Identifier: NCT03443193
Recruitment Status : Active, not recruiting
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Montreal Heart Institute

Brief 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.

Condition or disease Intervention/treatment Phase
Coronary Heart Disease Healthy Control Other: Exercise training Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: The Effects of Periodization Training on Physiological Parameters, Cerebral Oxygenation, Cognitive Functions and Cardiac Remodelling in Coronary Patients.
Actual Study Start Date : December 16, 2015
Actual Primary Completion Date : September 30, 2017
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Linear training
Linear training consists to a progressive improvement of the training load during the 3 month-program.
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.

Experimental: Non-linear training
Non-linear training consists to an undulating progressive improvement of the training load during the 3 month-program.
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.




Primary Outcome Measures :
  1. Maximal oxygen uptake (VO2peak) with gas exchange [ Time Frame: At baseline and following 12 weeks exercise training intervention ]
    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.


Secondary Outcome Measures :
  1. Cerebral hemodynamics [ Time Frame: At baseline and following 12 weeks exercise training intervention ]
    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

  2. Cognitive functions at rest by a by standard pen-paper battery test [ Time Frame: At baseline and following 12 weeks exercise training intervention ]
    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.

  3. Cardiac hemodynamics [ Time Frame: At baseline and following 12 weeks exercise training intervention ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443193


Locations
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Canada, Quebec
Cardiovascular prevention and rehabilitation center
Montréal, Quebec, Canada, H1T 1N6
Sponsors and Collaborators
Montreal Heart Institute

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Responsible Party: Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT03443193     History of Changes
Other Study ID Numbers: MontrealHI 2015-1895
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Montreal Heart Institute:
aerobic exercise training
periodization
cerebral oxygenation and perfusion
cognition

Additional relevant MeSH terms:
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Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases