Back to results

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

Primary Purpose

Coronary Heart Disease, Healthy Control

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Exercise training

About this trial

This is an interventional treatment trial for Coronary Heart Disease focused on measuring aerobic exercise training, periodization, cerebral oxygenation and perfusion, cognition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Cardiovascular prevention and rehabilitation center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Linear training

Non-linear training

Arm Description

Linear training consists to a progressive improvement of the training load during the 3 month-program.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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.

Standard echocardiographic parameter of left and right ventricular strain

global longitudinal strain (%) will be measued at rest for both ventricule

Full Information

NCT ID

NCT03443193

First Posted

January 22, 2018

Last Updated

August 29, 2022

Sponsor

Montreal Heart Institute

1. Study Identification

Unique Protocol Identification Number

NCT03443193

Brief Title

Periodization of Exercise Training in Patients With Coronary Heart Disease.

Acronym

PERIOD

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

December 16, 2015 (Actual)

Primary Completion Date

September 30, 2017 (Actual)

Study Completion Date

December 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Montreal Heart Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Heart Disease, Healthy Control

Keywords

aerobic exercise training, periodization, cerebral oxygenation and perfusion, cognition

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Linear training

Arm Type

Experimental

Arm Description

Linear training consists to a progressive improvement of the training load during the 3 month-program.

Arm Title

Non-linear training

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Exercise training

Intervention Description

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 Measure Information:

Title

Maximal oxygen uptake (VO2peak) with gas exchange

Description

Time Frame