Cognition and Exercise Training (COGNEX-2)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Montreal Heart Institute
Sponsor:
Information provided by (Responsible Party):
Mathieu Gayda, Montreal Heart Institute
ClinicalTrials.gov Identifier:
NCT01906957
First received: July 11, 2013
Last updated: June 10, 2014
Last verified: June 2014
  Purpose

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.


Condition Intervention
Metabolic Syndrome
Coronary Heart Disease
Chronic Heart Failure
Other: high intensity interval training (HIIT)
Other: moderate intensity continuous exercise training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Cerebral Oxygenation, Cardiac Output,Cognitive Function, and Exercise Training in Patients With Metabolic Syndrome, Coronary Heart Disease and Chronic Heart Failure.

Resource links provided by NLM:


Further study details as provided by Montreal Heart Institute:

Primary Outcome Measures:
  • Cognitive function assessed by standard pen-paper battery test [ Time Frame: At baseline and after 3 months ] [ Designated as safety issue: No ]
    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) [ Time Frame: At baseline and after 3 months ] [ Designated as safety issue: No ]
    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.


Other Outcome Measures:
  • Maximal cardiac output and stroke volume [ Time Frame: At baselin and after 3 months ] [ Designated as safety issue: No ]
    Maximal cardiac output and stroke volume wil be measured continuously at rest, during exercise and recovery using an impedance cardiography device.

  • Cerebral hemodynamics with NIRS [ Time Frame: At baseline and after 3 months ] [ Designated as safety issue: No ]
    Cerebral oxygenation/perfusion will be measured using near-infrared spectroscopy (NIRS) system during maximal exercise and recovery.

  • Microvascular function at the forearm level (NIRS) [ Time Frame: At baseline and after 3 months ] [ Designated as safety issue: No ]
    Microvascular function will be assessed using during reactive hyperemia using near-infra red spectroscopy (NIRS) placed on top of the brachio-radialis muscle.


Estimated Enrollment: 160
Study Start Date: September 2013
Estimated Study Completion Date: October 2018
Estimated Primary Completion Date: September 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Elderly healthy subjects

Randomization into :

  1. high intensity interval training (HIIT)(n=20)

    or

  2. moderate intensity intensity continuous exercise (n=20)
Other: high intensity interval training (HIIT)
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).
Other: moderate intensity continuous exercise training
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.
Experimental: Patients with metabolic syndrome

Randomization into :

  1. high intensity interval training (HIIT)(n=20)

    or

  2. moderate intensity intensity continuous exercise (n=20)
Other: high intensity interval training (HIIT)
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).
Other: moderate intensity continuous exercise training
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.
Experimental: coronary patients

Randomization into :

  1. high intensity interval training (HIIT)(n=20)

    or

  2. moderate intensity intensity continuous exercise (n=20)
Other: high intensity interval training (HIIT)
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).
Other: moderate intensity continuous exercise training
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.
Experimental: heart failure patients

Randomization into :

  1. high intensity interval training (HIIT)(n=20)

    or

  2. moderate intensity intensity continuous exercise (n=20)
Other: high intensity interval training (HIIT)
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).
Other: moderate intensity continuous exercise training
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01906957

Contacts
Contact: Julie Lalongé, RT 514-374-1480 ext 259 julie.lalonge@icm-mhi.org
Contact: Mathieu Gayda, Ph.D 514-374-1480 ext 268 mathieu.gayda@icm-mhi.org

Locations
Canada, Quebec
Cardiovascular Prevention and Rehabilitation Centre (EPIC), Montreal Heart Institute Not yet recruiting
Montreal, Quebec, Canada, H1T1N6
Contact: Julie Lalongé, RT    514-374-1480 ext 259    julie.lalonge@icm-mhi.org   
Principal Investigator: Mathieu Gayda, Ph.D         
Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute Recruiting
Montreal, Quebec, Canada, H1T 1N6
Contact: Julie Lalongé    +1-514-374-1480 ext 259    julie.lalonge@icm-mhi.org   
Principal Investigator: Mathieu Gayda, Ph.D         
Sponsors and Collaborators
Montreal Heart Institute
Investigators
Principal Investigator: Mathieu Gayda, Ph.D Montreal Heart Institute
  More Information

No publications provided

Responsible Party: Mathieu Gayda, P.hD, Montreal Heart Institute
ClinicalTrials.gov Identifier: NCT01906957     History of Changes
Other Study ID Numbers: COGNEX-2
Study First Received: July 11, 2013
Last Updated: June 10, 2014
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Failure
Metabolic Syndrome X
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 26, 2014