Effects of Physical and Cognitive Training in Neuroplasticity, Health and Cognition. Movement Project

Study Overview
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Brief Summary
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The MoveMent project applies non-pharmacological strategies - physical exercise and cognitive training - that have been shown to be effective in promoting active and healthy aging. The objective is to study the molecular and neural mechanisms of these strategies to stimulate brain plasticity and improve brain health and cognitive functioning.

Detailed Description
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It is a randomized controlled study with three intervention groups - physical, cognitive and combined - and a control group. The intervention is carried out over 3 months, with a frequency of 5 weekly sessions of 45 minutes each. Cognitive training is applied through a computerized program, physical training consists of a walking aerobic program, and combined training arises from the addition of the two previous ones. 140 participants will undergo an exhaustive pre- and post-intervention evaluation that includes neuropsychological, neuroimaging, genetic and biochemical analysis before and after the intervention as well as physical and health status assessment. The present project aims to examine the independent and combined effects of exercise and cognitive stimulation in functional and structural brain plasticity, cognitive performance, emotional state and quality of life, and will determine the demographic and clinical factors that can modulate neuroplasticity. It will allow us to study the neurophysiological mechanisms by which the different types of intervention have an effect on the structure and functioning of the brain and cognition within an omics framework.

Official Title
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Neuroplasticity in Adulthood: Physical Exercise and Cognitive Training; Integrative Omics Study on the Neurobiological Effects of Physical Activity and Cognitive Stimulation

Conditions
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Aging, Cognitive Function 1, Social

Intervention / Treatment
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* Behavioral: Physical exercise
* Behavioral: Cognitive training
* Behavioral: Combined training


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 50 and 70 Underactive or sedentary (<2 hours a week of physical activity). Adequate visual, auditory and fine motor skills. Able to speak and understand Catalan or Spanish language. Accept to take part in the study and sign the informed consent according to the Declaration of Helsinki. Exclusion Criteria: Mini mental State examination < 24 and Montreal Cognitive Assessment- Short (MoCA -S) < 6. Diagnosis of mild cognitive impairment, dementia or other serious neurological, psychiatric, or systemic illness. Presence of another illness that render them unable to engage in physical activity (signs or symptoms of chronic heart disease, chronic obstructive pulmonary disease, orthopedic problems). History of drug abuse or alcoholism. Psychotropic consumption Contraindication to magnetic resonance imaging

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Physical exercise (n= 40)<br>Walking program up to 45 minutes, 5 times a week for 3 months. | Behavioral: Physical exercise<br>* The structured physical activity plan consists of a walking program with an initial progressive phase (first week: 30 minutes/session and second week: 45 minutes/session, with a Borg scale of perceived exertion between 9 and 10) and an improvement and maintenance phase (10 weeks, 45 minutes/session with a Borg scale of perceived exertion between 11 and 14).<br>|
| Experimental: Cognitive training (n=40)<br>Computerized cognitive training up to 45 minutes, 5 times a week for 3 months. | Behavioral: Cognitive training<br>* We use a computerized cognitive training tele-medicine tool, designed by the Guttmann Institute: Guttmann Neuro Personal Trainer (PREVIRNET). Sessions will consist in activities of attention, memory and executive functions, also put in place progressively and parallel to the physical activity.<br>|
| Experimental: Combined training (n=40)<br>Exercise and cognitive training up to 90 minutes, 5 times a week for 3 months. | Behavioral: Combined training<br>* Subjects included in this group receive both types of intervention.<br>|
| No Intervention: Control group (n=20)<br>Waiting list group.They receive no intervention during this waiting period. At the end of this period our training programs are available to them. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in functional and structural brain plasticity assessed with Magnetic Resonance Imaging | Resting state connectivity, structural connectivity, white matter integrity, tractography, volume of white and grey matter structures. | Baseline and 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cognitive function | Tests of executive function, attention, memory, language, visuospatial abilities and speed | Baseline and 3 months | 
| Changes in emotional and functional status: Cognitive decline | Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly (Short IQCODE) | Baseline and 3 months | 
| Changes in emotional and functional status: Depression | Geriatric Depression Scale (GDS) | Baseline and 3 months | 
| Changes in emotional and functional status: Mood | Adapted Visual Analog Mood Scale (VAMS) | Baseline and 3 months | 
| Changes in emotional and functional status: Clinical outcome | Spanish version of the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) | Baseline and 3 months | 
| Changes in health, fitness and physical activity: Cardiovascular risk factors | Cardiovascular risk factors | Baseline and 3 months | 
| Changes in health, fitness and physical activity: Sleep | Pittsburgh Sleep quality Index | Baseline and 3 months | 
| Changes in health, fitness and physical activity: Physical activity questionnaire | Spanish version of the reduced Minnesota leisure time physical and activity questionnaire (VREM) | Baseline and 3 months | 
| Changes in health, fitness and physical activity: Fitness | One-mile Rockport walk test | Baseline and 3 months | 
| Changes in health, fitness and physical activity: Physical activity monitoring | Polar Loop activity monitoring device. | Baseline and 3 months | 
| Changes in metabolites and gene expression patterns | Metabolomic and transcriptomic analyses | Baseline and 3 months |