NCT03443193

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 16, 2015

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 22, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
3.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

September 1, 2022

Status Verified

August 1, 2022

Enrollment Period

1.8 years

First QC Date

January 22, 2018

Last Update Submit

August 29, 2022

Conditions

Coronary Heart DiseaseHealthy Control

Keywords

aerobic exercise trainingperiodizationcerebral oxygenation and perfusioncognition

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Cerebral hemodynamics

    At baseline and following 12 weeks exercise training intervention

  • Cognitive functions at rest by a by standard pen-paper battery test

    At baseline and following 12 weeks exercise training intervention

  • Cardiac hemodynamics

    At baseline and following 12 weeks exercise training intervention

  • Standard echocardiographic parameter of left and right ventricular strain

    At baseline and following 12 weeks exercise training intervention

Study Arms (2)

Linear training

EXPERIMENTAL

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

Other: Exercise training

Non-linear training

EXPERIMENTAL

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

Other: Exercise training

Interventions

Exercise trainingOTHER

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

Linear trainingNon-linear training

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Major
  • Adequate physical and mental capacities
  • Autonomy in daily activities
  • Documented coronary artery disease
  • Stable or recent coronary artery disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cardiovascular prevention and rehabilitation center

Montreal, Quebec, H1T 1N6, Canada

Location

Related Publications (2)

  • Boidin M, David LP, Trachsel LD, Gayda M, Tremblay J, Lalonge J, Juneau M, Nigam A, Henri C. Impact of 2 different aerobic periodization training protocols on left ventricular function in patients with stable coronary artery disease: an exploratory study. Appl Physiol Nutr Metab. 2021 May;46(5):436-442. doi: 10.1139/apnm-2020-0423. Epub 2020 Oct 27.

    PMID: 33108743DERIVED

  • Trachsel LD, Boidin M, Henri C, Fortier A, Lalonge J, Juneau M, Nigam A, Gayda M. Women and men with coronary heart disease respond similarly to different aerobic exercise training modalities: a pooled analysis of prospective randomized trials. Appl Physiol Nutr Metab. 2021 May;46(5):417-425. doi: 10.1139/apnm-2020-0650. Epub 2020 Oct 23.

    PMID: 33096006DERIVED

MeSH Terms

Conditions

Coronary Disease

Interventions

Exercise

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 22, 2018

First Posted

February 23, 2018

Study Start

December 16, 2015

Primary Completion

September 30, 2017

Study Completion

December 31, 2021

Last Updated

September 1, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)