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

October 22, 2018 updated by: Maria Mataro Serrat, University of Barcelona

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Barcelona
      • Mataro, Barcelona, Spain, 08303
        • Centre Atenció Primària el Maresme

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Physical exercise (n= 40)
Walking program up to 45 minutes, 5 times a week for 3 months.
Behavioral: 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).
Experimental: Cognitive training (n=40)
Computerized cognitive training up to 45 minutes, 5 times a week for 3 months.
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.
Experimental: Combined training (n=40)
Exercise and cognitive training up to 90 minutes, 5 times a week for 3 months.
Behavioral: Combined training
Subjects included in this group receive both types of intervention.
No 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in functional and structural brain plasticity assessed with Magnetic Resonance Imaging
Time Frame: Baseline and 3 months
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
Time Frame: Baseline and 3 months
Tests of executive function, attention, memory, language, visuospatial abilities and speed
Baseline and 3 months
Changes in emotional and functional status: Cognitive decline
Time Frame: Baseline and 3 months
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
Time Frame: Baseline and 3 months
Geriatric Depression Scale (GDS)
Baseline and 3 months
Changes in emotional and functional status: Mood
Time Frame: Baseline and 3 months
Adapted Visual Analog Mood Scale (VAMS)
Baseline and 3 months
Changes in emotional and functional status: Clinical outcome
Time Frame: Baseline and 3 months
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
Time Frame: Baseline and 3 months
Cardiovascular risk factors
Baseline and 3 months
Changes in health, fitness and physical activity: Sleep
Time Frame: Baseline and 3 months
Pittsburgh Sleep quality Index
Baseline and 3 months
Changes in health, fitness and physical activity: Physical activity questionnaire
Time Frame: Baseline and 3 months
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
Time Frame: Baseline and 3 months
One-mile Rockport walk test
Baseline and 3 months
Changes in health, fitness and physical activity: Physical activity monitoring
Time Frame: Baseline and 3 months
Polar Loop activity monitoring device.
Baseline and 3 months
Changes in metabolites and gene expression patterns
Time Frame: Baseline and 3 months
Metabolomic and transcriptomic analyses
Baseline and 3 months

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in global cognitive function
Time Frame: Baseline and 3 months
Mini mental state examination
Baseline and 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Barcelona

Collaborators

University of Pittsburgh
Germans Trias i Pujol Hospital
Ministerio de Economía y Competitividad, Spain
Universitat Politècnica de Catalunya
Institut Guttmann
Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina

Investigators

  • Principal Investigator: Maria Mataro Serrat, Ph.D., University of Barcelona

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 26, 2015

Primary Completion (Actual)

April 8, 2018

Study Completion (Actual)

April 8, 2018

Study Registration Dates

First Submitted

March 6, 2017

First Submitted That Met QC Criteria

April 17, 2017

First Posted (Actual)

April 21, 2017

Study Record Updates

Last Update Posted (Actual)

October 23, 2018

Last Update Submitted That Met QC Criteria

October 22, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • PSI2013-47724P
  • PSI2016-77475R (Other Grant/Funding Number: Ministry of Economy and Competitiveness)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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