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

Aging Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03123900
• Other study ID #: PSI2013-47724P
• Secondary ID: PSI2016-77475R
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Aging
• Cognitive Function 1, Social

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

External Links

•   blog of the project
•   IDIAP Jordi Gol
•   Neuroscience Institute University of Barcelona