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

Обзор

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.

Подробное описание

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, pulsatility and neurovascular coupling and to assess the role of sex on intervention effects.

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.

Вмешательства

• Другое Cognitive training
  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 taug
• Другое Exercise training
  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
• Другое Usual care
  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

Первичные конечные точки

• Change in general cognitive functioning [Срок оценки: Baseline and post-intervention at 6 months]
• Change in processing speed [Срок оценки: Baseline and post-intervention at 6 months]
• Change in executive functions [Срок оценки: Baseline and post-intervention at 6 months]
• Change in episodic memory [Срок оценки: Baseline and post-intervention at 6 months]

Вторичные конечные точки (5)

• Change in cerebral autoregulation - frontal cortical region [Срок оценки: Baseline and post-intervention at 6 months]
• Change in cerebral autoregulation - middle cerebral arteries [Срок оценки: Baseline and post-intervention at 6 months]
• Change in cerebral pulsatility - cortical frontal region [Срок оценки: Baseline and post-intervention at 6 months]
• Change in cerebral pulsatility - middle cerebral arteries [Срок оценки: Baseline and post-intervention at 6 months]
• Change in cerebral activity [Срок оценки: Baseline and post-intervention at 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Профилактика

Центры проведения

Канада · 1 центр

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

Публикации

• Bherer L, Besnier F, Gagnon C, Vrinceanu T, Vincent T, Mohammadi H, Gauthier C, Duquesne C, Blanchette CA, Berube B, Said SN, Iglesies-Grau J, L'Allier P, Boulet J, Nigam A, Dionne V, Benhalima H, Dube MP, Duchesne S, Belleville S, Brassard P, Gagnon D, Lesage F, Gayda M, Soucy JP, Bouabdallaoui N, Liu-Ambrose T, Barha C, Poirier J, Eric Thorin, Vu M, Tournoux F, Vitali P, O'Meara E, Racine N, Rou PMID 42327429

Идентификаторы

NCT: NCT04970888 · MP-33-2018-2406

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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