Clinical trial NCT03123900: Effects of Physical and Cognitive Training in Neuroplasticity, Health and Cognition. Movement Project
Official title: Neuroplasticity in Adulthood: Physical Exercise and Cognitive Training; Integrative Omics Study on the Neurobiological Effects of Physical Activity and Cognitive Stimulation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Cognitive Function 1, Social
Lead sponsor: University of Barcelona
Sponsor class: OTHER
Collaborators: name: Ministerio de Economía y Competitividad, Spain
name: Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
name: Universitat Politècnica de Catalunya
name: Institut Guttmann
name: Germans Trias i Pujol Hospital
name: University of Pittsburgh
First posted: 2017-04-21
Enrollment: 110
Sex: ALL
Minimum age (years): 50
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Changes in functional and structural brain plasticity assessed with Magnetic Resonance Imaging
timeFrame: Baseline and 3 months
Secondary outcomes:
measure: Changes in cognitive function
timeFrame: Baseline and 3 months
measure: Changes in emotional and functional status: Cognitive decline
timeFrame: Baseline and 3 months
measure: Changes in emotional and functional status: Depression
timeFrame: Baseline and 3 months
measure: Changes in emotional and functional status: Mood
timeFrame: Baseline and 3 months
measure: Changes in emotional and functional status: Clinical outcome
timeFrame: Baseline and 3 months
measure: Changes in health, fitness and physical activity: Cardiovascular risk factors
timeFrame: Baseline and 3 months
measure: Changes in health, fitness and physical activity: Sleep
timeFrame: Baseline and 3 months
measure: Changes in health, fitness and physical activity: Physical activity questionnaire
timeFrame: Baseline and 3 months
measure: Changes in health, fitness and physical activity: Fitness
timeFrame: Baseline and 3 months
measure: Changes in health, fitness and physical activity: Physical activity monitoring
timeFrame: Baseline and 3 months
measure: Changes in metabolites and gene expression patterns
timeFrame: Baseline and 3 months
Other outcomes:
measure: Changes in global cognitive function
timeFrame: Baseline and 3 months
Locations:
city: Mataro
country: Spain
facility: Centre Atenció Primària el Maresme
state: Barcelona
Study officials:
affiliation: University of Barcelona
name: Maria Mataro Serrat, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roig-Coll F, Castells-Sanchez A, Lamonja-Vicente N, Toran-Monserrat P, Pera G, Garcia-Molina A, Tormos JM, Montero-Alia P, Alzamora MT, Dacosta-Aguayo R, Soriano-Raya JJ, Caceres C, Erickson KI, Mataro M. Effects of Aerobic Exercise, Cognitive and Combined Training on Cognition in Physically Inactive Healthy Late-Middle-Aged Adults: The Projecte Moviment Randomized Controlled Trial. Front Aging Neurosci. 2020 Oct 29;12:590168. doi: 10.3389/fnagi.2020.590168. eCollection 2020.
citation: Castells-Sanchez A, Roig-Coll F, Lamonja-Vicente N, Altes-Magret M, Toran-Monserrat P, Via M, Garcia-Molina A, Tormos JM, Heras A, Alzamora MT, Fores R, Pera G, Dacosta-Aguayo R, Soriano-Raya JJ, Caceres C, Montero-Alia P, Montero-Alia JJ, Jimenez-Gonzalez MM, Hernandez-Perez M, Perera A, Grove GA, Munuera J, Domenech S, Erickson KI, Mataro M. Effects and Mechanisms of Cognitive, Aerobic Exercise, and Combined Training on Cognition, Health, and Brain Outcomes in Physically Inactive Older Adults: The Projecte Moviment Protocol. Front Aging Neurosci. 2019 Aug 14;11:216. doi: 10.3389/fnagi.2019.00216. eCollection 2019.