A Combined Multidomain Intervention to Prevent Cognitive Decline Associated With Cardiovascular Risk Factors.

Официальное название

Impacts of Aerobic, Resistance and Cognitive Training Interventions on Neurocognitive Functions in Older Adults With Cardiovascular Risk Factors.

Обзор

The ACTIONcardioRisk trial is designed to investigate the effect of aerobic and progressive resistance training exercises combined with cognitive training, on neurocognitive functioning of sedentary older adults with and without cardiovascular risk factors.

Подробное описание

The proportion of older adults is on the rise in Canada, with the fastest growth recorded among those seventy years of age or older. The prevalence of cardiovascular risk factors (CVRF) such as diabetes, hypertension, and high cholesterol increases drastically with age. Individuals with CVRF often show impaired cognition, such as attention and memory deficits. In healthy older adults, exercise training and cognitive stimulation can help enhance cognitive performances. More precisely, combined intervention, including physical and cognitive training, has shown beneficial effects on cognition in older adults without cognitive impairment and with mild cognitive impairment. However, the effect of such programs on cognition in individuals with CVRF is not well documented. This project compares the effect of a physical exercise program, including aerobic and resistance training, alone or combined with cognitive training on cognitive performances and brain imaging outcomes in individuals with CVRF and healthy controls.

Вмешательства

• Другое Cognitive Training
  Participants will be encouraged to perform sessions of cognitive training 3 times per week (30 minutes/session). 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 abou
• Другое Aerobic and resistance exercises
  Participants will follow a periodized exercise training program with thrice-weekly 60 minutes trainings. The sessions will start with a 5-10mins warm-up, followed by aerobic and resistance trainings, and ends with a 5-10mins cool-down and stretching period. Intensity of aerobic sessions will be monitored with heart rate chest strap and should match with the moderate to vigorous intensity zone as defined by the ACSM (65% of Heart Rate maximum or more and a Perceived Exertion higher than 12 on the
• Другое Stretching and Toning
  Participants in the active control condition will take part in three 60 minutes stretching and toning sessions per week. Each session will start with a five-minutes warm-up, followed by fifteen min of body stretching exercises mainly in a seated position and finish with a five-minutes cool down. Participants will engage in four muscle-toning exercises (light intensity) using dumbbells or resistance bands, two exercises designed to improve balance, one yoga sequence, and one exercise of their cho

Первичные конечные точки

• Change in general cognitive functioning [Срок оценки: Baseline and post-intervention at 12 months.]
• Change in processing speed [Срок оценки: Baseline and post-intervention at 12 months.]
• Change in executive functions [Срок оценки: Baseline and post-intervention at 12 months.]
• Change in episodic memory [Срок оценки: Baseline and post-intervention at 12 months.]

Вторичные конечные точки (9)

• Change in cerebral autoregulation - frontal cortical region [Срок оценки: Baseline and post-intervention at 12 months.]
• Change in cerebral autoregulation - middle cerebral arteries [Срок оценки: Baseline and post-intervention at 12 months.]
• Change in cerebral vasoreactivity - whole brain [Срок оценки: Baseline and post-intervention at 12 months.]
• Change in cerebral vasoreactivity - prefrontal cortex [Срок оценки: Baseline and post-intervention at 12 months.]
• Change in cerebral vasoreactivity - middle cerebral arteries [Срок оценки: Baseline and post-intervention at 12 months.]
• Change in cerebral pulsatility - cortical frontal region [Срок оценки: Baseline and post-intervention at 12 months.]
• Change in cerebral pulsatility - middle cerebral arteries [Срок оценки: Baseline and post-intervention at 12 months.]
• Change in cerebral activity [Срок оценки: Baseline and post-intervention at 12 months.]
• Change in brain structure [Срок оценки: Baseline and post-intervention at 12 months.]

Критерии участия

Критерии включения

• Adult aged 60 and older,
• Normal or corrected vision and normal hearing for their age range,
• No cognitive impairment (Mini-Mental State Examination - MMSE ≥ 25),
• Inactive (< 150 min of physical activity per week).

Критерии исключения

• MMSE ≤ 24 or diagnosis of dementia,
• Uncontrolled psychological / psychiatric condition within the past 6 months,
• Neurological disease,
• Severe exercise intolerance,
• Respiratory disease (e.g., asthma, COPD),
• Excessive alcohol consumption (> 15 drinks/week),
• Documented cerebral, peripheral or coronary atherosclerotic disease,
• Chronic systolic or diastolic heart failure,
• Symptomatic aortic stenosis,
• Atrial fibrillation,
• Automatic implantable defibrillator or permanent pacemaker,
• Malignant exertional arrhythmias,
• Non-cardiopulmonary limitation to exercise (e.g., arthritis).

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

Здоровые добровольцы: Да

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

• Arntzen KA, Schirmer H, Wilsgaard T, Mathiesen EB. Impact of cardiovascular risk factors on cognitive function: the Tromso study. Eur J Neurol. 2011 May;18(5):737-43. doi: 10.1111/j.1468-1331.2010.03263.x. Epub 2010 Dec 8. PMID 21143340
• Baker LD, Frank LL, Foster-Schubert K, Green PS, Wilkinson CW, McTiernan A, Cholerton BA, Plymate SR, Fishel MA, Watson GS, Duncan GE, Mehta PD, Craft S. Aerobic exercise improves cognition for older adults with glucose intolerance, a risk factor for Alzheimer's disease. J Alzheimers Dis. 2010;22(2):569-79. doi: 10.3233/JAD-2010-100768. PMID 20847403
• Bherer L, Kramer AF, Peterson MS, Colcombe S, Erickson K, Becic E. Training effects on dual-task performance: are there age-related differences in plasticity of attentional control? Psychol Aging. 2005 Dec;20(4):695-709. doi: 10.1037/0882-7974.20.4.695. PMID 16420143
• Colcombe S, Kramer AF. Fitness effects on the cognitive function of older adults: a meta-analytic study. Psychol Sci. 2003 Mar;14(2):125-30. doi: 10.1111/1467-9280.t01-1-01430. PMID 12661673
• DeRight J, Jorgensen RS, Cabral MJ. Composite cardiovascular risk scores and neuropsychological functioning: a meta-analytic review. Ann Behav Med. 2015 Jun;49(3):344-57. doi: 10.1007/s12160-014-9681-0. PMID 25616781
• Dregan A, Stewart R, Gulliford MC. Cardiovascular risk factors and cognitive decline in adults aged 50 and over: a population-based cohort study. Age Ageing. 2013 May;42(3):338-45. doi: 10.1093/ageing/afs166. Epub 2012 Nov 25. PMID 23179255
• Erickson KI, Colcombe SJ, Wadhwa R, Bherer L, Peterson MS, Scalf PE, Kim JS, Alvarado M, Kramer AF. Training-induced functional activation changes in dual-task processing: an FMRI study. Cereb Cortex. 2007 Jan;17(1):192-204. doi: 10.1093/cercor/bhj137. Epub 2006 Feb 8. PMID 16467562
• Eskelinen MH, Ngandu T, Helkala EL, Tuomilehto J, Nissinen A, Soininen H, Kivipelto M. Fat intake at midlife and cognitive impairment later in life: a population-based CAIDE study. Int J Geriatr Psychiatry. 2008 Jul;23(7):741-7. doi: 10.1002/gps.1969. PMID 18188871

Идентификаторы

NCT: NCT04962061 · 2019-2545

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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