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Comparing the Effects of Cognitive Training and Physical Exercise on Cognition, Cerebral Autoregulation and Cerebral Vasoreactivity in Men and Women With Heart Failure (ReCARDIO)

Primary Purpose

Chronic Heart Failure, Aging

Status

Recruiting

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Cognitive training

Exercise training

Usual care

About this trial

This is an interventional prevention trial for Chronic Heart Failure focused on measuring cognition, physical exercise, cognitive training, brain functions, combined intervention, heart failure, biomarkers, cerebral vasoreactivity, fitness

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age ≥ 60 years old
Stable chronic HF on maximally tolerated background treatment for at least 2 months (stable therapy with ACE-I, ARBs and MRA for at least 2 months), regardless of LVEF
with no limitation of physical activity in ordinary physical activity (i.e. NYHA class I), moderate symptoms (i.e. NYHA class II) or marked limitation in activity (i.e. NYHA class III)
Able to perform cognitive and physical training.

Exclusion Criteria:

Acute cardiovascular event 1 month prior to randomization, including emergency visit or hospitalization for decompensated HF, acute myocardial infarction, stroke, and transient ischemic attack
Planned cardiovascular intervention within 6 months (implantation of any cardiac device, cardiac revascularization, heart transplantation)
Severe exercise intolerance
Contraindications for exercise testing (e.g., uncorrected severe aortic or carotid stenosis, severe pulmonary hypertension, severe non-revascularizable coronary disease including left main coronary stenosis, significant myocardial ischemia or arrhythmia during low-intensity exercise, acute HF)
Severe respiratory disease
Non-cardiopulmonary limitation to exercise (e.g., arthritis, claudication or any peripheral neurological disease including other neurodegenerative diseases such as disabling Parkinson)
Uncontrolled diabetes or untreated thyroid dysfunction
Current or recent malignancy with life expectancy < 1 year
Chronic hemodialysis or peritoneal dialysis
Unable to read the informed consent form or unable to understand the oral explanations provided by the assessor.

Sites / Locations

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Combined

Exercise

Usual care

Arm Description

Combined physical exercise and cognitive training. The combined intervention will include a cognitive training with aerobic and resistance exercises training, three sessions per week for 6 months. Participants will be allowed to perform cognitive and exercise training sessions either home-based or centre-based.

The physical exercises intervention will include aerobic and resistance exercises training, three sessions per week for 6 months. Participants will be allowed to perform exercise training sessions either home-based or centre-based.

Usual medical care with no interventions

Outcomes

Primary Outcome Measures

Change in general cognitive functioning

Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).

Change in processing speed

Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).

Change in executive functions

Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).

Change in episodic memory

Validated remote version of neuropsychological tests (Composite Z-score).

Secondary Outcome Measures

Change in cerebral autoregulation - frontal cortical region

Variations of prefrontal cortical oxygen saturation (rSO2, [HbO]/([HbO]+[HbR])) will be measured by Near Infrared Spectroscopy (NIRS), as a surrogate of cortical blood flow. Variations of continuous peripheral blood pressure (mm Hg) will be simultaneously measured by plethysmography at the finger. Autoregulation indices (unitless) will be derived from the correlation between variations of oxygen saturation measures and variations of peripheral blood pressure.

Change in cerebral autoregulation - middle cerebral arteries

Variations of cerebral blood flow velocity (cm/s) at the level of the middle cerebral artery will be measured by Transcranial Doppler (TCD). Variations of continuous peripheral blood pressure (mm Hg) will be simultaneously measured by plethysmography at the finger. Autoregulation indices (unitless) will be derived from the correlation between variations of cerebral blood flow measures and variations of peripheral blood pressure.

Change in cerebral vasoreactivity - prefrontal cortex

Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using NIRS in the prefrontal region.

Change in cerebral vasoreactivity - middle cerebral arteries

Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using TCD in the middle cerebral arteries.

Change in cerebral pulsatility - cortical frontal region

Pulsatility will be measured as the normalized difference of relative near-infrared light intensity changes between systole and diastole, using NIRS in the prefrontal cortical region.

Change in cerebral pulsatility - middle cerebral arteries

Pulsatility will be measured as the normalized difference of relative blood flow velocities between systole and diastole, using TCD in the middle cerebral arteries

Change in cerebral activity

Significant changes in brain activity evoked by a N-back task relative to baseline will be assessed by t-statistics maps, computed from variations of [HbO] and [HbR] measured by NIRS at the prefrontal cortex.

Full Information

NCT ID

NCT04970888

First Posted

July 12, 2021

Last Updated

September 29, 2021

Sponsor

Montreal Heart Institute

Collaborators

Canadian Institutes of Health Research (CIHR), The Montreal Health Innovations Coordinating Center (MHICC)

1. Study Identification

Unique Protocol Identification Number

NCT04970888

Brief Title

Comparing the Effects of Cognitive Training and Physical Exercise on Cognition, Cerebral Autoregulation and Cerebral Vasoreactivity in Men and Women With Heart Failure

Acronym

ReCARDIO

Official Title

Comparing the Effects of Cognitive Training and Physical Exercise on Cognition, Cerebral Autoregulation and Cerebral Vasoreactivity in Men and Women With Heart Failure

Study Type

Interventional

2. Study Status

Record Verification Date

September 2021

Overall Recruitment Status

Recruiting

Study Start Date

September 1, 2021 (Actual)

Primary Completion Date

September 1, 2025 (Anticipated)

Study Completion Date

September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Montreal Heart Institute

Collaborators

Canadian Institutes of Health Research (CIHR), The Montreal Health Innovations Coordinating Center (MHICC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The objective of this project is to assess the effects of combined physical exercise and cognitive training interventions on cognitive and brain health in patients with heart failure (HF). Also, the role of sex on the effects of the interventions will be assessed.

Detailed Description

Cognitive impairment (CI) affects up to 50% of patients with heart failure (HF), and is associated with high mortality rates, poor quality of life, reduced functional capacities, and an overwhelming economic burden in Western countries. Non-pharmacological strategies could help enhance cognition in HF patients with CI. Combined physical exercise and cognitive training interventions have recently shown promising enhancement effects on cognition in patients with cardiovascular risk factors and mild cognitive impairment. The effects of combined interventions have never been tested in HF. The main objective is to assess the effects of combined physical exercise and cognitive training interventions on cognition in patients with HF. Secondary objectives include: to characterize baseline and intervention-related changes in cerebral autoregulation and vasoreactivity and to assess the role of sex on the effects of the interventions. Two-hundred and sixteen participants (36 men and 36 women/group) with stable HF regardless of aetiology and LVEF will take part in this study. All participants will have signed a written consent form before taking part in the study. Patients will be stratified according to sex and LVEF (FEVG < 40% et FEVG > 40%), and will be randomly assigned to one of the 3 following study arms: 1) Combined physical exercise and cognitive training; 2) Physical exercise alone; and 3) Usual medical care.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Heart Failure, Aging

Keywords

cognition, physical exercise, cognitive training, brain functions, combined intervention, heart failure, biomarkers, cerebral vasoreactivity, fitness

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

parallel assignment (1:1:1)

Masking

InvestigatorOutcomes Assessor

Masking Description

This clinical trial is a single-blinded study. Research personnel performing the outcome assessments and investigators will be blinded to group allocation.

Allocation

Randomized

Enrollment

216 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Combined

Arm Type

Experimental

Arm Description

Arm Title

Exercise

Arm Type

Experimental

Arm Description

Arm Title

Usual care

Arm Type

Active Comparator

Arm Description

Usual medical care with no interventions

Intervention Type

Other

Intervention Name(s)

Cognitive training

Intervention Description

The cognitive training will involve attention control training and memory training, with thrice-weekly 30-min sessions. Two of these sessions will involve computer or tablet-based attentional control training targeting dual-tasking, updating and working memory, as well as inhibition and switching. Difficulty of cognitive training will be tailored to participants' performances. The remaining session will consist of memory training. Participants will be instructed mnemotechnic, as well as be taught about memory in aging in general.

Intervention Type

Other

Intervention Name(s)

Exercise training

Intervention Description

Participants will follow a 20-week physical training program, with 60-min thrice-weekly trainings. The training sessions will start with a 5-min warm-up, followed by an aerobic training (20 min) after which 20-min of resistance/muscular training will take place. The program will end with a 10-min cool-down. Training will be adapted to individuals' baseline capacity as measured by the baseline cardiorespiratory test. For home-training sessions, participants will have access to a complete exercise training program. A certified kinesiologist will supervise trainings. With the Heart rate sensor Polar H10, all the characteristics of the activities will be recorded (type of the activity, intensity, heart rate, duration). A kinesiologist will call participants every week to ensure the smooth running of the exercises training sessions and individualize the care according to the patient's level.

Intervention Type

Other

Intervention Name(s)

Usual care

Intervention Description

All patients will receive usual care and be treated according to evidence-based treatments. This will include optimal medical therapy, systematic information regarding dietary and fluid management, and a recommendation for regular physical activity consistent with the latest update of the Canadian Cardiovascular Society Guidelines for the Management of Heart Failure. Moreover, patients who benefit from a prescription for a cardiovascular rehabilitation program will be able to follow it, but they will not receive other forms of intervention for the duration of the study.

Primary Outcome Measure Information:

Title

Change in general cognitive functioning

Description

Montreal Cognitive Assessment (0-30 score, with a higher score indicating a better cognitive functioning).

Time Frame

Baseline and post-intervention at 6 months

Title

Change in processing speed

Description

Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).

Time Frame

Baseline and post-intervention at 6 months

Title

Change in executive functions

Description

Validated remote version of neuropsychological tests and iPad tests (Composite Z-score).

Time Frame

Baseline and post-intervention at 6 months

Title

Change in episodic memory

Description

Validated remote version of neuropsychological tests (Composite Z-score).

Time Frame

Baseline and post-intervention at 6 months

Secondary Outcome Measure Information:

Title

Change in cerebral autoregulation - frontal cortical region

Description

Time Frame

Baseline and post-intervention at 6 months

Title

Change in cerebral autoregulation - middle cerebral arteries

Description

Time Frame

Baseline and post-intervention at 6 months

Title

Change in cerebral vasoreactivity - prefrontal cortex

Description

Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using NIRS in the prefrontal region.

Time Frame

Baseline and post-intervention at 6 months

Title

Change in cerebral vasoreactivity - middle cerebral arteries

Description

Cerebral VasoReactivity (CVR, % change per mm Hg of PaCO2) will be measured using TCD in the middle cerebral arteries.

Time Frame

Baseline and post-intervention at 6 months

Title

Change in cerebral pulsatility - cortical frontal region

Description

Pulsatility will be measured as the normalized difference of relative near-infrared light intensity changes between systole and diastole, using NIRS in the prefrontal cortical region.

Time Frame

Baseline and post-intervention at 6 months

Title

Change in cerebral pulsatility - middle cerebral arteries

Description

Pulsatility will be measured as the normalized difference of relative blood flow velocities between systole and diastole, using TCD in the middle cerebral arteries

Time Frame

Baseline and post-intervention at 6 months

Title

Change in cerebral activity

Description

Time Frame

Baseline and post-intervention at 6 months

Other Pre-specified Outcome Measures:

Title

Change in cardiorespiratory fitness

Description

Maximum incremental cardiopulmonary exercise test (VO2 max (ml.kg.min)

Time Frame

Baseline and post-intervention at 6 months

Title

Change in 6-min walking test performance

Description

maximum distance performed in 6 minutes (distance, m)

Time Frame

Baseline and post-intervention at 6 months

Title

Change in upper limb muscle strength

Description

Grip strength test score (kg).

Time Frame

Baseline and post-intervention at 6 months

Title

Change in quality of life

Description

score on the 23 items of the Kansas City Cardiomyopathy Questionnaire (KCCQ)

Time Frame

Baseline and post-intervention at 6 months

Title

Change in perceived self care behaviour

Description

European Heart Failure Self-care Behaviour Scale (EHFScB-9) will be completed. This self-reported questionnaire assesses the adherence to different self-care behaviours (e.g., eating low-salt diet, etc.).

Time Frame

Baseline and post-intervention at 6 months

Title

Change in anxiety

Description

State-Trait Anxiety Inventory questionnaire (Score ranges from 20-80, with a higher score indicating higher anxiety).

Time Frame

Baseline and post-intervention at 6 months

Title

Change in depressive symptoms

Description

Geriatric Depression Scale questionnaire (Score ranges from 0-30, with a higher score indicating larger depressive symptomatology).

Time Frame

Baseline and post-intervention at 6 months

Title

Change in sleep quality

Description

Pittsburgh Sleep Quality Index questionnaire (Score ranges from 0-21, with a higher score indicating worse sleep quality). symptomatology).

Time Frame

Baseline and post-intervention at 6 months

Title

Cognitive reserve

Description

Rami and colleagues' cognitive reserve questionnaire (Scale ranges from 0-26, with a higher score indicating a greater cognitive reserve).

Time Frame

Baseline

Title

Genotyping data

Description

genotyping data that include the APOE gene

Time Frame

baseline

Title

Change in NT-pro-BNP

Description

NT-pro-BNP (ng/L)

Time Frame

Baseline and post-intervention at 6 months

Title

Change in high-sensitive Troponin T

Description

hsTnT (ng/mL)

Time Frame

Baseline and post-intervention at 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age ≥ 60 years old Stable chronic HF on maximally tolerated background treatment for at least 2 months (stable therapy with ACE-I, ARBs and MRA for at least 2 months), regardless of LVEF with no limitation of physical activity in ordinary physical activity (i.e. NYHA class I), moderate symptoms (i.e. NYHA class II) or marked limitation in activity (i.e. NYHA class III) Able to perform cognitive and physical training. Exclusion Criteria: Acute cardiovascular event 1 month prior to randomization, including emergency visit or hospitalization for decompensated HF, acute myocardial infarction, stroke, and transient ischemic attack Planned cardiovascular intervention within 6 months (implantation of any cardiac device, cardiac revascularization, heart transplantation) Severe exercise intolerance Contraindications for exercise testing (e.g., uncorrected severe aortic or carotid stenosis, severe pulmonary hypertension, severe non-revascularizable coronary disease including left main coronary stenosis, significant myocardial ischemia or arrhythmia during low-intensity exercise, acute HF) Severe respiratory disease Non-cardiopulmonary limitation to exercise (e.g., arthritis, claudication or any peripheral neurological disease including other neurodegenerative diseases such as disabling Parkinson) Uncontrolled diabetes or untreated thyroid dysfunction Current or recent malignancy with life expectancy < 1 year Chronic hemodialysis or peritoneal dialysis Unable to read the informed consent form or unable to understand the oral explanations provided by the assessor.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Louis Bherer, PhD

Phone

+1 514-374-1480

Ext

4355

louis.bherer@umontreal.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Florent Besnier, PhD

Phone

+1 514-374-1480

Ext

4333

florent.besnier@umontreal.ca

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Louis Bherer, PhD

Organizational Affiliation

Montreal Heart Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

Preventive medicine and physical activity centre (centre EPIC), Montreal Heart Institute

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H1T1N6

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Louis Bherer, PhD

Phone

514-374-1480

Ext

4355

louis.bherer@umontreal.ca

First Name & Middle Initial & Last Name & Degree

Louis Bherer, PhD

First Name & Middle Initial & Last Name & Degree

Anil Nigam, MD

First Name & Middle Initial & Last Name & Degree

Jean Rouleau, MD

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

Comparing the Effects of Cognitive Training and Physical Exercise on Cognition, Cerebral Autoregulation and Cerebral Vasoreactivity in Men and Women With Heart Failure

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