Cognition and Exercise Training
Information source: Montreal Heart Institute
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Metabolic Syndrome; Coronary Heart Disease; Chronic Heart Failure
Intervention: high intensity interval training (HIIT) (Other); moderate intensity continuous exercise training (Other)
Phase: N/A
Status: Recruiting
Sponsored by: Montreal Heart Institute Official(s) and/or principal investigator(s):
Mathieu Gayda, Ph.D, Principal Investigator, Affiliation: Montreal Heart Institute
Overall contact:
Julie Lalongé, RT, Phone: 514-374-1480, Ext: 259, Email: julie.lalonge@icm-mhi.org
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.
Clinical Details
Official title: Cerebral Oxygenation, Cardiac Output,Cognitive Function, and Exercise Training in Patients With Metabolic Syndrome, Coronary Heart Disease and Chronic Heart Failure.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Cognitive function assessed by standard pen-paper battery test
Secondary outcome: Maximal aerobic capacity (VO2max)
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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.
Locations and Contacts
Julie Lalongé, RT, Phone: 514-374-1480, Ext: 259, Email: julie.lalonge@icm-mhi.org
Cardiovascular Prevention and Rehabilitation Centre (EPIC), Montreal Heart Institute, Montreal, Quebec H1T1N6, Canada; Not yet recruiting
Julie Lalongé, RT, Phone: 514-374-1480, Ext: 259, Email: julie.lalonge@icm-mhi.org
Mathieu Gayda, Ph.D, Principal Investigator
Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute, Montreal, Quebec H1T 1N6, Canada; Recruiting
Julie Lalongé, Phone: +1-514-374-1480, Ext: 259, Email: julie.lalonge@icm-mhi.org
Mathieu Gayda, Ph.D, Principal Investigator
Additional Information
Starting date: September 2013
Last updated: June 10, 2014
|
