Coronary Heart DiseasePERIODNCT03443193
Periodization of Exercise Training in Patients With Coronary Heart Disease.
A study testing Exercise training in people with Coronary Heart Disease and Healthy Control, run by Montreal Heart Institute at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronary Heart Disease, Healthy Control
- What is being tested?
- Exercise training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteCanada
- Study dates
- 16 Dec 2015to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
1 site in 1 country.
Canada1 site
Cardiovascular prevention and rehabilitation center
Montreal, Quebec, H1T 1N6
About this study
Official title: 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.
- Conditions
- Coronary Heart Disease, Healthy Control
- Being tested
- Exercise training
- Keywords
- aerobic exercise training, periodization, cerebral oxygenation and perfusion, cognition
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Linear training | Experimental | Linear training consists to a progressive improvement of the training load during the 3 month-program. Receives: 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. Receives: Other: Exercise training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At baseline and following 12 weeks exercise training intervention
Secondary outcomes (4)
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
Measured: At baseline and following 12 weeks exercise training intervention
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.
Measured: At baseline and following 12 weeks exercise training intervention
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.
Measured: At baseline and following 12 weeks exercise training intervention
Standard echocardiographic parameter of left and right ventricular strain
global longitudinal strain (%) will be measued at rest for both ventricule
Measured: At baseline and following 12 weeks exercise training intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2018
- Study start16 Dec 2015
- Primary completion30 Sep 2017
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Montreal Heart Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03443193
- Sponsor's protocol ID
- MontrealHI 2015-1895
- Acronym
- PERIOD
- Status last verified
- Aug 2022
- First submitted
- 22 Jan 2018
- Last updated
- 1 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gayda M, Trachsel LD, Besnier F, Boidin M, Lalonge J, Bherer L, Juneau M, Lepretre PM, Nigam A. Effects of different exercise training programs on post-exercise [Formula: see text]O2 recovery responses in patients with coronary heart disease. Eur J Appl Physiol. 2026 Jun;126(6):3393-3406. doi: 10.1007/s00421-026-06146-4. Epub 2026 Feb 25.
PubMed 41739167Boidin 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.
PubMed 33108743Trachsel 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.
PubMed 33096006
Study at a glance
From the registry record, last updated by the sponsor on 1 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Periodization Training on Physiological Parameters, Cerebral Oxygenation, Cognitive Functions and Cardiac Remodelling in Coronary Patients.
- ClinicalTrials.gov ID
- NCT03443193
- Acronym / sponsor ID
- PERIOD / MontrealHI 2015-1895
- Conditions
- Coronary Heart Disease, Healthy Control
- Keywords
- aerobic exercise training, periodization, cerebral oxygenation and perfusion, cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Montreal Heart InstituteUniversity, hospital or other
- Study start
- 16 Dec 2015 (actual)
- Primary completion
- 30 Sep 2017 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 23 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Linear training | Experimental | Other: Exercise trainingLinear training consists to a progressive improvement of the training load during the 3 month-program. |
| Non-linear training | Experimental | Other: Exercise trainingNon-linear training consists to an undulating progressive improvement of the training load during the 3 month-program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise trainingPatients will undergo three weekly exercise training sessions with periodized high-intensity interval training and resistance training for a period of 12 weeks. | Other | Linear training, Non-linear training |
Primary outcome
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.
4 secondary outcomes
Cerebral hemodynamics
Time frame: 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
Cardiac hemodynamics
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Sep 2022.
- Derived from this study: PubMed 41739167Gayda M, Trachsel LD, Besnier F, Boidin M, Lalonge J, Bherer L, Juneau M, Lepretre PM, Nigam A. Effects of different exercise training programs on post-exercise [Formula: see text]O2 recovery responses in patients with coronary heart disease. Eur J Appl Physiol. 2026 Jun;126(6):3393-3406. doi: 10.1007/s00421-026-06146-4. Epub 2026 Feb 25.
- Derived from this study: PubMed 33108743Boidin 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.
- Derived from this study: PubMed 33096006Trachsel 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise training in people with Coronary Heart Disease and Healthy Control, run by Montreal Heart Institute at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximal oxygen uptake (VO2peak) with gas exchange (time frame: At baseline and following 12 weeks exercise training intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03443193, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Sep 2022.