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Completed

NCT Number: NCT03123900

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

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.

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Key information

Conditions

Aging Cognitive Function 1, Social

Age range

50 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre Atenció Primària el Maresme

Mataró, Barcelona, 08303, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical exercise

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

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

Behavioral

Subjects included in this group receive both types of intervention.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Changes in cognitive function

    Time frame: Baseline and 3 months

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

  2. 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)

  3. Changes in emotional and functional status: Depression

    Time frame: Baseline and 3 months

    Geriatric Depression Scale (GDS)

  4. Changes in emotional and functional status: Mood

    Time frame: Baseline and 3 months

    Adapted Visual Analog Mood Scale (VAMS)

  5. 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)

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

    Time frame: Baseline and 3 months

    Cardiovascular risk factors

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

    Time frame: Baseline and 3 months

    Pittsburgh Sleep quality Index

  8. 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)

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

    Time frame: Baseline and 3 months

    One-mile Rockport walk test

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

    Time frame: Baseline and 3 months

    Polar Loop activity monitoring device.

  11. Changes in metabolites and gene expression patterns

    Time frame: Baseline and 3 months

    Metabolomic and transcriptomic analyses

Other outcomes

  1. Changes in global cognitive function

    Time frame: Baseline and 3 months

    Mini mental state examination

Sponsors and collaborators

Lead sponsor

University of Barcelona

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2018
Study completion
2018
First posted
Apr 21, 2017
Registry last updated
Oct 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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