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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03123900
Other study ID # PSI2013-47724P
Secondary ID PSI2016-77475R
Status Completed
Phase N/A
First received
Last updated
Start date November 26, 2015
Est. completion date April 8, 2018

Study information

Verified date October 2018
Source University of Barcelona
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. The objective is to study the molecular and neural mechanisms of these strategies to stimulate brain plasticity and improve brain health and cognitive functioning.


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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date April 8, 2018
Est. primary completion date April 8, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 70 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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).
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.
Combined training
Subjects included in this group receive both types of intervention.

Locations

Country Name City State
Spain Centre Atenció Primària el Maresme Mataro Barcelona

Sponsors (7)

Lead Sponsor Collaborator
University of Barcelona Germans Trias i Pujol Hospital, Institut Guttmann, Jordi Gol i Gurina Foundation, Ministerio de Economía y Competitividad, Spain, Universitat Politècnica de Catalunya, University of Pittsburgh

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Other Changes in global cognitive function Mini mental state examination Baseline and 3 months
Primary 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 Changes in cognitive function Tests of executive function, attention, memory, language, visuospatial abilities and speed Baseline and 3 months
Secondary Changes in emotional and functional status: Cognitive decline Short Form of the Informant Questionnaire on Cognitive Decline in the Elderly (Short IQCODE) Baseline and 3 months
Secondary Changes in emotional and functional status: Depression Geriatric Depression Scale (GDS) Baseline and 3 months
Secondary Changes in emotional and functional status: Mood Adapted Visual Analog Mood Scale (VAMS) Baseline and 3 months
Secondary Changes in emotional and functional status: Clinical outcome Spanish version of the Clinical Outcomes in Routine Evaluation - Outcome Measure (CORE-OM) Baseline and 3 months
Secondary Changes in health, fitness and physical activity: Cardiovascular risk factors Cardiovascular risk factors Baseline and 3 months
Secondary Changes in health, fitness and physical activity: Sleep Pittsburgh Sleep quality Index Baseline and 3 months
Secondary Changes in health, fitness and physical activity: Physical activity questionnaire Spanish version of the reduced Minnesota leisure time physical and activity questionnaire (VREM) Baseline and 3 months
Secondary Changes in health, fitness and physical activity: Fitness One-mile Rockport walk test Baseline and 3 months
Secondary Changes in health, fitness and physical activity: Physical activity monitoring Polar Loop activity monitoring device. Baseline and 3 months
Secondary Changes in metabolites and gene expression patterns Metabolomic and transcriptomic analyses Baseline and 3 months
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