Cognition and Exercise Training (COGNEX-2)

This study is currently recruiting participants.
Verified September 2013 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: September 9, 2013
Last verified: September 2013

July 11, 2013
September 9, 2013
September 2013
September 2018   (final data collection date for primary outcome measure)
Cognitive function assessed by standard pen-paper battery test [ Time Frame: Before and after 3 months of training ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01906957 on ClinicalTrials.gov Archive Site
Maximal aerobic capacity (VO2max) [ Time Frame: VO2max before and after 3 months of training ] [ Designated as safety issue: No ]
Same as current
  • Maximal cardiac output and stroke volume [ Time Frame: Qmax and SVmax before and after 3 months of training ] [ Designated as safety issue: No ]
  • Cerebral hemodynamics with NIRS [ Time Frame: Brain NIRS signals before and after 3 months of training ] [ Designated as safety issue: No ]
  • Microvascular function at the forearm level (NIRS) [ Time Frame: Forearm NIRS signals before and after 3 months of training ] [ Designated as safety issue: No ]
Same as current
 
Cognition and Exercise Training
Cerebral Oxygenation, Cardiac Output,Cognitive Function, and Exercise Training in Patients With Metabolic Syndrome, Coronary Heart Disease and Chronic Heart Failure.

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Metabolic Syndrome
  • Coronary Heart Disease
  • Chronic Heart Failure
  • 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: Elderly healthy subjects

    Randomization into :

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

      or

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

    Randomization into :

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

      or

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

    Randomization into :

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

      or

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

    Randomization into :

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

      or

    2. moderate intensity intensity continuous exercise (n=20)
    Interventions:
    • Other: high intensity interval training (HIIT)
    • Other: moderate intensity continuous exercise training
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
October 2018
September 2018   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
Yes
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
Canada
 
NCT01906957
COGNEX-2
Yes
Mathieu Gayda, Montreal Heart Institute
Montreal Heart Institute
Not Provided
Principal Investigator: Mathieu Gayda, Ph.D Montreal Heart Institute
Montreal Heart Institute
September 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP