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Cognition and Exercise Training (COGNEX-2)

Primary Purpose

Metabolic Syndrome, Coronary Heart Disease, Chronic Heart Failure

Status
Terminated
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
high intensity interval training (HIIT)
moderate intensity continuous exercise training
Sponsored by
Montreal Heart Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolic Syndrome

Eligibility Criteria

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

Inclusion criteria:

Elderly healthy subjects : with no MetS and no-documented CHD, both males and females, aged>60 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living.

Patients with metabolic syndrome and no-documented CHD, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. MetS will be defined according to recent updated criteria: presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off depending on the recently published ethnic-based variations, triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l.

CHD patients, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Moreover, they must have documented CHD (prior myocardial infarction, prior coronary angiography or angioplasty, or documented myocardial ischemia on myocardial scintigraphy).

Patients with documented stable chronic heart failure will be recruited if they show the following inclusion criteria:

  • ≥18 years
  • Left ventricular ejection fraction (LVEF) <40% (measured within 6 months of their enrolment by MUGA Scan, echo or radiological ventriculography)
  • NYHA functional class I-III
  • Optimal therapy at stable doses including a beta-blocker and an ACE inhibitor or ARA for at least 6 weeks prior to investigation (unless documented rationale for variation).
  • Able to perform an symptom limited exercise test.
  • Capacity and willingness to sign the informed consent form.

Exclusion Criteria:

  • For healthy elderly subjects:
  • age under 60 years
  • lack of expressed written consent
  • metabolic syndrome
  • coronary heart disease
  • chronic systolic heart failure
  • resting left ventricular ejection fraction < 40 %
  • symptomatic aortic stenosis
  • chronic atrial fibrillation
  • malignant exertional arrhythmias
  • non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)
  • severe exercise intolerance.

For patients with metabolic syndrome:

  • lack of expressed written consent
  • coronary heart disease
  • chronic systolic heart failure
  • resting left ventricular ejection fraction < 40 %
  • symptomatic aortic stenosis
  • chronic atrial fibrillation
  • malignant exertional arrhythmias
  • non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)
  • severe exercise intolerance.

For patients with CHD

  • lack of expressed written consent
  • recent acute coronary event (< 3 months)
  • chronic systolic heart failure
  • resting left ventricular ejection fraction < 40 %
  • symptomatic aortic stenosis
  • severe non-revascularize coronary disease including left main coronary stenosis
  • patient awaiting coronary artery bypass surgery
  • chronic atrial fibrillation
  • presence of permanent ventricular pacemaker
  • malignant exertional arrhythmias
  • non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication)
  • severe exercise intolerance.

For CHF patients:

  • Any relative or absolute contraindications to exercise training among patients with stable chronic heart failure according to current recommendations (Working Group on Cardiac Rehabilitation 2001)
  • Fixed-rate pacemaker or ICD devices with heart rate limits set lower than the exercise training target heart rate.
  • Major cardiovascular event of procedure within the 3 months preceding enrolment in the study.
  • Atrial fibrillation
  • Heart failure secondary to significant uncorrected primary valvular disease (except for mitral regurgitation secondary to LV dysfunction)
  • Heart failure secondary to congenital heart disease or obstructive cardiomyopathy.

Sites / Locations

  • Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute
  • Cardiovascular Prevention and Rehabilitation Centre (EPIC), Montreal Heart Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Elderly healthy subjects

Patients with metabolic syndrome

coronary patients

heart failure patients

Arm Description

Randomization into : high intensity interval training (HIIT)(n=20) or moderate intensity intensity continuous exercise (n=20)

Randomization into : high intensity interval training (HIIT)(n=20) or moderate intensity intensity continuous exercise (n=20)

Randomization into : high intensity interval training (HIIT)(n=20) or moderate intensity intensity continuous exercise (n=20)

Randomization into : high intensity interval training (HIIT)(n=20) or moderate intensity intensity continuous exercise (n=20)

Outcomes

Primary Outcome Measures

Cognitive function assessed by standard pen-paper battery test
a) Digit Span (Forward and Backward) (short-term and working memory), b) Digit Symbol Substitution Test (attention & processing speed), c) Trail making test, part A and B (mental flexibility), d) D-KEFS Color-Word Interference Stroop Test (selective attention and inhibition) and e) Rey Auditory Verbal Learning Test (long-term verbal memory).

Secondary Outcome Measures

Maximal aerobic capacity (VO2max)
Gas exchanges will be measured during maximal incremental test. The highest value reached during the exercise phase of the maximal test (ergocycle) will be considered as the VO2max.

Full Information

First Posted
July 11, 2013
Last Updated
September 9, 2022
Sponsor
Montreal Heart Institute
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1. Study Identification

Unique Protocol Identification Number
NCT01906957
Brief Title
Cognition and Exercise Training
Acronym
COGNEX-2
Official Title
Cerebral Oxygenation, Cardiac Output,Cognitive Function, and Exercise Training in Patients With Metabolic Syndrome, Coronary Heart Disease and Chronic Heart Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Terminated
Why Stopped
Not sufficient financial - staff resources
Study Start Date
September 2013 (Actual)
Primary Completion Date
September 2018 (Actual)
Study Completion Date
September 9, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Montreal Heart Institute

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The aim of study is to investigate the impact of two different training modalities (high intensity interval training (HIIT) versus moderate intensity continuous exercise training (MICET) on cognitive performance, cerebral oxygenation, cardiac output and physical fitness in older healthy adults, patients with metabolic syndrome, coronary heart disease and heart failure. The investigators hypothesized that HIIT modality will lead to a larger improvement in physical fitness (i.e. VO2peak), cardiovascular parameters (cardiac output and stroke volume) and cognitive performance at rest and during submaximal exercise. The primary endpoint will be the improvement in cognitive performance.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Coronary Heart Disease, Chronic Heart Failure

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
6 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Elderly healthy subjects
Arm Type
Experimental
Arm Description
Randomization into : high intensity interval training (HIIT)(n=20) or moderate intensity intensity continuous exercise (n=20)
Arm Title
Patients with metabolic syndrome
Arm Type
Experimental
Arm Description
Randomization into : high intensity interval training (HIIT)(n=20) or moderate intensity intensity continuous exercise (n=20)
Arm Title
coronary patients
Arm Type
Experimental
Arm Description
Randomization into : high intensity interval training (HIIT)(n=20) or moderate intensity intensity continuous exercise (n=20)
Arm Title
heart failure patients
Arm Type
Experimental
Arm Description
Randomization into : high intensity interval training (HIIT)(n=20) or moderate intensity intensity continuous exercise (n=20)
Intervention Type
Other
Intervention Name(s)
high intensity interval training (HIIT)
Intervention Description
High-intensity interval exercise (HIIE) session This HIIE session will be based on a previous study conducted in our laboratory that compared physiological, psychological and electrocardiological tolerance of four different single bouts of HIIE in coronary patients (Guiraud et al. 2010). The selected HIIE session represented the best compromise between safety, time spent at a high level of VO2peak and psychological adherence. This HIIE session consists of a 10-min warm-up at 50% of MAP, followed by two sets of 10 min composed of repeated bouts of 15 s at 100% of MAP interspersed by 15 s of passive recovery. Four minutes of passive recovery were allowed between the two sets, as well as a 5-min cool-down after the last 15-s exercise bout. A total duration of 35 minutes will be employed for this session for coronary artery disease patients, and 22 minutes for chronic heart failure patients (Guiraut et al. 2010 b).
Intervention Type
Other
Intervention Name(s)
moderate intensity continuous exercise training
Intervention Description
Moderate Intensity Continuous Exercise (MICE) session This exercise session will be based on the recommendations of the American Heart Association on exercise prescription in cardiac rehabilitation (Balady et al. 2007), suggesting that exercise intensity should lie between 50% and 80% of maximal aerobic power (MAP). We opted for an intensity of 70% of MAP. Duration will be adjusted to match total energy expenditure of the HIIE, according to the previous methodology method (Guiraud et al. 2010 b). A total duration of 28.7 minutes will be employed in healthy elderly patients, coronary artery disease patients and patients with metabolic syndrom; and 16 minutes in chronic heart failure patients.
Primary Outcome Measure Information:
Title
Cognitive function assessed by standard pen-paper battery test
Description
a) Digit Span (Forward and Backward) (short-term and working memory), b) Digit Symbol Substitution Test (attention & processing speed), c) Trail making test, part A and B (mental flexibility), d) D-KEFS Color-Word Interference Stroop Test (selective attention and inhibition) and e) Rey Auditory Verbal Learning Test (long-term verbal memory).
Time Frame
At baseline and after 3 months
Secondary Outcome Measure Information:
Title
Maximal aerobic capacity (VO2max)
Description
Gas exchanges will be measured during maximal incremental test. The highest value reached during the exercise phase of the maximal test (ergocycle) will be considered as the VO2max.
Time Frame
At baseline and after 3 months
Other Pre-specified Outcome Measures:
Title
Maximal cardiac output and stroke volume
Description
Maximal cardiac output and stroke volume wil be measured continuously at rest, during exercise and recovery using an impedance cardiography device.
Time Frame
At baselin and after 3 months
Title
Cerebral hemodynamics with NIRS
Description
Cerebral oxygenation/perfusion will be measured using near-infrared spectroscopy (NIRS) system during maximal exercise and recovery.
Time Frame
At baseline and after 3 months
Title
Microvascular function at the forearm level (NIRS)
Description
Microvascular function will be assessed using during reactive hyperemia using near-infra red spectroscopy (NIRS) placed on top of the brachio-radialis muscle.
Time Frame
At baseline and after 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria: Elderly healthy subjects : with no MetS and no-documented CHD, both males and females, aged>60 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Patients with metabolic syndrome and no-documented CHD, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. MetS will be defined according to recent updated criteria: presence of at least three of five criteria, namely abdominal obesity (waist circumference cut-off depending on the recently published ethnic-based variations, triglycerides > 1.70 mmol/l, decreased HDL-cholesterol (< 1.0 mmol/l in men and < 1.3 mmol/l in women), systolic blood pressure > 130 mmHg or diastolic blood pressure > 85 mmHg, and FPG > 5.6 mmol/l. CHD patients, both males and females, aged > 18 years will be included in the study, should they provide written informed consent and have a sufficient initial physical and intellectual capacities allowing an independent daily living. Moreover, they must have documented CHD (prior myocardial infarction, prior coronary angiography or angioplasty, or documented myocardial ischemia on myocardial scintigraphy). Patients with documented stable chronic heart failure will be recruited if they show the following inclusion criteria: ≥18 years Left ventricular ejection fraction (LVEF) <40% (measured within 6 months of their enrolment by MUGA Scan, echo or radiological ventriculography) NYHA functional class I-III Optimal therapy at stable doses including a beta-blocker and an ACE inhibitor or ARA for at least 6 weeks prior to investigation (unless documented rationale for variation). Able to perform an symptom limited exercise test. Capacity and willingness to sign the informed consent form. Exclusion Criteria: For healthy elderly subjects: age under 60 years lack of expressed written consent metabolic syndrome coronary heart disease chronic systolic heart failure resting left ventricular ejection fraction < 40 % symptomatic aortic stenosis chronic atrial fibrillation malignant exertional arrhythmias non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication) severe exercise intolerance. For patients with metabolic syndrome: lack of expressed written consent coronary heart disease chronic systolic heart failure resting left ventricular ejection fraction < 40 % symptomatic aortic stenosis chronic atrial fibrillation malignant exertional arrhythmias non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication) severe exercise intolerance. For patients with CHD lack of expressed written consent recent acute coronary event (< 3 months) chronic systolic heart failure resting left ventricular ejection fraction < 40 % symptomatic aortic stenosis severe non-revascularize coronary disease including left main coronary stenosis patient awaiting coronary artery bypass surgery chronic atrial fibrillation presence of permanent ventricular pacemaker malignant exertional arrhythmias non-cardiopulmonary limitation to exercise (e.g: arthritis or claudication) severe exercise intolerance. For CHF patients: Any relative or absolute contraindications to exercise training among patients with stable chronic heart failure according to current recommendations (Working Group on Cardiac Rehabilitation 2001) Fixed-rate pacemaker or ICD devices with heart rate limits set lower than the exercise training target heart rate. Major cardiovascular event of procedure within the 3 months preceding enrolment in the study. Atrial fibrillation Heart failure secondary to significant uncorrected primary valvular disease (except for mitral regurgitation secondary to LV dysfunction) Heart failure secondary to congenital heart disease or obstructive cardiomyopathy.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mathieu Gayda, Ph.D
Organizational Affiliation
Montreal Heart Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T 1N6
Country
Canada
Facility Name
Cardiovascular Prevention and Rehabilitation Centre (EPIC), Montreal Heart Institute
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H1T1N6
Country
Canada

12. IPD Sharing Statement

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Cognition and Exercise Training

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