Cognition and Exercise Training

NCT01906957 | Terminated DMC

• 1 other identifier: COGNEX-2
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 2

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.

Conditions

Metabolic Syndrome; Coronary Heart Disease; Chronic Heart Failure

Outcome Measures

Primary Outcomes (1)

• 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).

  At baseline and after 3 months

Secondary Outcomes (1)

• Maximal aerobic capacity (VO2max)

  At baseline and after 3 months

Other Outcomes (3)

• Maximal cardiac output and stroke volume

  At baselin and after 3 months

• Cerebral hemodynamics with NIRS

  At baseline and after 3 months

• Microvascular function at the forearm level (NIRS)

  At baseline and after 3 months

Study Arms (4)

Elderly healthy subjects

EXPERIMENTAL

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); Other: moderate intensity continuous exercise training

Patients with metabolic syndrome

EXPERIMENTAL

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); Other: moderate intensity continuous exercise training

coronary patients

EXPERIMENTAL

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); Other: moderate intensity continuous exercise training

heart failure patients

EXPERIMENTAL

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); Other: moderate intensity continuous exercise training

Interventions

high intensity interval training (HIIT) OTHER

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).

Elderly healthy subjects; Patients with metabolic syndrome; coronary patients; heart failure patients

moderate intensity continuous exercise training OTHER

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.

Elderly healthy subjects; Patients with metabolic syndrome; coronary patients; heart failure patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• ≥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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Montreal Heart Institute: lead

Study Sites (2)

Cardiovascular Prevention and Rehabilitation Centre, Montreal Heart Institute

Montreal, Quebec, H1T 1N6, Canada

Location

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

Montreal, Quebec, H1T1N6, Canada

Location

MeSH Terms

Conditions

Metabolic Syndrome; Coronary Disease

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Mathieu Gayda, Ph.D

  Montreal Heart Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: P.hD

Study Record Dates

• First Submitted: July 11, 2013
• First Posted: July 24, 2013
• Study Start: September 1, 2013
• Primary Completion: September 1, 2018
• Study Completion: September 9, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Locations

CA (2)