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Completed

NCT Number: NCT03443193

Periodization of Exercise Training in Patients With Coronary Heart Disease.

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.

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Healthy Control Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cardiovascular prevention and rehabilitation center

Montreal, Quebec, H1T 1N6, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise training

Other

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

Primary outcomes

  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 outcomes

  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.

  4. 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

Sponsors and collaborators

Lead sponsor

Montreal Heart Institute

Other

Registry information

Official study title

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

Acronym: PERIOD

Important dates

Study start
2015
Primary completion
2017
Study completion
2021
First posted
Feb 23, 2018
Registry last updated
Sep 1, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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