NCT03123900

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Nov 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 26, 2015

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

March 6, 2017

Completed
2 months until next milestone

First Posted

Study publicly available on registry

April 21, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 8, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 8, 2018

Completed
Last Updated

October 23, 2018

Status Verified

October 1, 2018

Enrollment Period

2.4 years

First QC Date

March 6, 2017

Last Update Submit

October 22, 2018

Conditions

AgingCognitive Function 1, Social

Outcome Measures

Primary Outcomes (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.

    Baseline and 3 months

Secondary Outcomes (11)

  • Changes in cognitive function

    Baseline and 3 months

  • Changes in emotional and functional status: Cognitive decline

    Baseline and 3 months

  • Changes in emotional and functional status: Depression

    Baseline and 3 months

  • Changes in emotional and functional status: Mood

    Baseline and 3 months

  • Changes in emotional and functional status: Clinical outcome

    Baseline and 3 months

  • +6 more secondary outcomes

Other Outcomes (1)

  • Changes in global cognitive function

    Baseline and 3 months

Study Arms (4)

Physical exercise (n= 40)

EXPERIMENTAL

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

Behavioral: Physical exercise

Cognitive training (n=40)

EXPERIMENTAL

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

Behavioral: Cognitive training

Combined training (n=40)

EXPERIMENTAL

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

Behavioral: Combined training

Control group (n=20)

NO INTERVENTION

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

Interventions

Physical exerciseBEHAVIORAL

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).

Physical exercise (n= 40)
Cognitive trainingBEHAVIORAL

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.

Cognitive training (n=40)
Combined trainingBEHAVIORAL

Subjects included in this group receive both types of intervention.

Combined training (n=40)

Eligibility Criteria

Age50 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre Atenció Primària el Maresme

Mataró, Barcelona, 08303, Spain

Location

Related Publications (2)

  • 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.

    PMID: 33192485DERIVED

  • 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.

    PMID: 31481889DERIVED

Related Links

MeSH Terms

Interventions

ExerciseCognitive Training

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Maria Mataro Serrat, Ph.D.

    University of Barcelona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Associate professor

Study Record Dates

First Submitted

March 6, 2017

First Posted

April 21, 2017

Study Start

November 26, 2015

Primary Completion

April 8, 2018

Study Completion

April 8, 2018

Last Updated

October 23, 2018

Record last verified: 2018-10

Locations

ES(1)