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

NCT ID: NCT03123900

Last Updated: 2018-10-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-11-26

Study Completion Date

2018-04-08

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.

Conditions

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Aging Cognitive Function 1, Social

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Physical exercise (n= 40)

Walking program up to 45 minutes, 5 times a week for 3 months.

Group Type EXPERIMENTAL

Physical exercise

Intervention Type BEHAVIORAL

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).

Cognitive training (n=40)

Computerized cognitive training up to 45 minutes, 5 times a week for 3 months.

Group Type EXPERIMENTAL

Cognitive training

Intervention Type BEHAVIORAL

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.

Combined training (n=40)

Exercise and cognitive training up to 90 minutes, 5 times a week for 3 months.

Group Type EXPERIMENTAL

Combined training

Intervention Type BEHAVIORAL

Subjects included in this group receive both types of intervention.

Control group (n=20)

Waiting list group.They receive no intervention during this waiting period. At the end of this period our training programs are available to them.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Physical exercise

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).

Intervention Type BEHAVIORAL

Cognitive training

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.

Intervention Type BEHAVIORAL

Combined training

Subjects included in this group receive both types of intervention.

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

50 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Ministerio de Economía y Competitividad, Spain

OTHER_GOV

Sponsor Role collaborator

Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

OTHER

Sponsor Role collaborator

Universitat Politècnica de Catalunya

OTHER

Sponsor Role collaborator

Institut Guttmann

OTHER

Sponsor Role collaborator

Germans Trias i Pujol Hospital

OTHER

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role collaborator

University of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Maria Mataro Serrat

PhD. Associate professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maria Mataro Serrat, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

University of Barcelona

Locations

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Centre Atenció Primària el Maresme

Mataró, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED
PMID: 33192485 (View on PubMed)

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.

Reference Type DERIVED
PMID: 31481889 (View on PubMed)

Related Links

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Other Identifiers

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PSI2016-77475R

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

PSI2013-47724P

Identifier Type: -

Identifier Source: org_study_id

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