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

August 29, 2022 updated by: Montreal Heart Institute

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H1T 1N6
        • Cardiovascular Prevention and Rehabilitation Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline and following 12 weeks exercise training intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
At baseline and following 12 weeks exercise training intervention
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.
At baseline and following 12 weeks exercise training intervention
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.
At baseline and following 12 weeks exercise training intervention
Standard echocardiographic parameter of left and right ventricular strain
Time Frame: At baseline and following 12 weeks exercise training intervention
global longitudinal strain (%) will be measued at rest for both ventricule
At baseline and following 12 weeks exercise training intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Montreal Heart Institute

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2015

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

January 22, 2018

First Submitted That Met QC Criteria

February 16, 2018

First Posted (Actual)

February 23, 2018

Study Record Updates

Last Update Posted (Actual)

September 1, 2022

Last Update Submitted That Met QC Criteria

August 29, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MontrealHI 2015-1895

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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