Comparing the Effects of Combining Cognitive and Physical Exercise Training on Cognition, and Cerebral Blood Flow Regulation in Men and Women With Chronic Heart Failure

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50+
SponsorMontreal Heart Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 50 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.

Disqualifiers

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)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Cognitive training

    Other intervention

    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.

  • Exercise training

    Other intervention

    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.

  • Usual care

    Other intervention

    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.

Treatment groups

216 Participants
are divided into 3 treatment groups
Group A: CombinedExperimental treatment 3 interventions
Group B: ExerciseExperimental treatment 2 interventions
Group C: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in general cognitive functioning

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

Time frame
Baseline and post-intervention at 6 months
2

Change in processing speed

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

Time frame
Baseline and post-intervention at 6 months
3

Change in executive functions

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

Time frame
Baseline and post-intervention at 6 months
4

Change in episodic memory

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

Time frame
Baseline and post-intervention at 6 months

Secondary outcomes

1

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.

Time frame
Baseline and post-intervention at 6 months
2

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.

Time frame
Baseline and post-intervention at 6 months
3

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.

Time frame
Baseline and post-intervention at 6 months
4

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

Time frame
Baseline and post-intervention at 6 months

Other outcomes

1

Change in cardiorespiratory fitness

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

Time frame
Baseline and post-intervention at 6 months
2

Change in 6-min walking test performance

maximum distance performed in 6 minutes (distance, m)

Time frame
Baseline and post-intervention at 6 months
3

Change in upper limb muscle strength

Grip strength test score (kg).

Time frame
Baseline and post-intervention at 6 months
4

Change in quality of life

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

Time frame
Baseline and post-intervention at 6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Montreal Heart Institute

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

The Montreal Health Innovations Coordinating Center (MHICC)

Collaborator