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AgingNCT03123900

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

A study testing Physical exercise, Cognitive training and Combined training in people with Aging and Cognitive Function 1, Social, run by University of Barcelona at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 70 yearsHealthy volunteers can take part
Conditions the study is for
Aging, Cognitive Function 1, Social
What is being tested?
Physical exercise, Cognitive training and Combined training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteSpain
Study dates
26 Nov 2015to 8 Apr 2018
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 70 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Centre Atenció Primària el Maresme

    Mataró, Barcelona, 08303

Other trials in Spain

About this study

Official title: 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.

Read the 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.

Being tested
Physical exercise, Cognitive training, Combined training

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical exerciseBehavioural

    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 trainingBehavioural

    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 trainingBehavioural

    Subjects included in this group receive both types of intervention.

Study groups in NCT03123900
Study groupRoleWhat they receive
Physical exercise (n= 40)ExperimentalWalking program up to 45 minutes, 5 times a week for 3 months.
Receives: Behavioral: Physical exercise
Cognitive training (n=40)ExperimentalComputerized cognitive training up to 45 minutes, 5 times a week for 3 months.
Receives: Behavioral: Cognitive training
Combined training (n=40)ExperimentalExercise and cognitive training up to 90 minutes, 5 times a week for 3 months.
Receives: Behavioral: Combined training
Control group (n=20)No interventionWaiting 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and 3 months

Secondary outcomes (11)

  1. Changes in cognitive function

    Tests of executive function, attention, memory, language, visuospatial abilities and speed

    Measured: Baseline and 3 months

  2. Changes in emotional and functional status: Cognitive decline

    Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly (Short IQCODE)

    Measured: Baseline and 3 months

  3. Changes in emotional and functional status: Depression

    Geriatric Depression Scale (GDS)

    Measured: Baseline and 3 months

  4. Changes in emotional and functional status: Mood

    Adapted Visual Analog Mood Scale (VAMS)

    Measured: Baseline and 3 months

  5. Changes in emotional and functional status: Clinical outcome

    Spanish version of the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM)

    Measured: Baseline and 3 months

  6. Changes in health, fitness and physical activity: Cardiovascular risk factors

    Cardiovascular risk factors

    Measured: Baseline and 3 months

  7. Changes in health, fitness and physical activity: Sleep

    Pittsburgh Sleep quality Index

    Measured: Baseline and 3 months

  8. Changes in health, fitness and physical activity: Physical activity questionnaire

    Spanish version of the reduced Minnesota leisure time physical and activity questionnaire (VREM)

    Measured: Baseline and 3 months

  9. Changes in health, fitness and physical activity: Fitness

    One-mile Rockport walk test

    Measured: Baseline and 3 months

  10. Changes in health, fitness and physical activity: Physical activity monitoring

    Polar Loop activity monitoring device.

    Measured: Baseline and 3 months

  11. Changes in metabolites and gene expression patterns

    Metabolomic and transcriptomic analyses

    Measured: Baseline and 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Apr 2017
  2. Study start26 Nov 2015
  3. Primary completion8 Apr 2018
  4. Study completion8 Apr 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Investigator, Outcomes assessor
Enrolment
110 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03123900
Sponsor's protocol ID
PSI2013-47724P
Other IDs
PSI2016-77475R
Status last verified
Oct 2018
First submitted
6 Mar 2017
Last updated
23 Oct 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 33192485

  • 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.

    PubMed 31481889

Questions about this trial

What is this clinical trial studying?

A study testing Physical exercise, Cognitive training and Combined training in people with Aging and Cognitive Function 1, Social, run by University of Barcelona at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in functional and structural brain plasticity assessed with Magnetic Resonance Imaging (time frame: Baseline and 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03123900, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2018.

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