Train the Brain - Cognitive and Physical Training for Slowing Dementia

NCT01725178 | Unknown

• 1 other identifier: TTB-01
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

Train The Brain is aimed at assessing the efficacy of cognitive and physical training in slowing progression to dementia in patients diagnosed with mild cognitive impairment (MCI).

Conditions

Mild Cognitive Impairment; Dementia; Memory Disorders

Keywords

Mild Cognitive Impairment; Dementia; Memory disorders; Physical fitness

Outcome Measures

Primary Outcomes (1)

• Rate of cognitive decline, measured as score in neuropsychological tests

  1) Baseline; 2) After seven months of intervention/control;3) Seven months after completion of intervention/control.

Secondary Outcomes (5)

• Modifications in brain activation during cognitive tasks, measured through functional magnetic resonance imaging

  Time Frame: 1) Baseline; 2) After seven months of intervention/control; 3) Seven months after completion of intervention/control.

• Rate of loss of grey and white matter in the cortex and the hippocampus, measured through Magnetic Resonance Imaging.

  1) Baseline; 2) After seven months of intervention/control; 3) Seven months after completion of intervention/control.

• Recovery of normal frequency spectra in the electroencephalographic signal

  1) Baseline; 2) After seven months of intervention/control; 3) Seven months after completion of intervention/control.

• Improvement in vascular function and structure, as variations in Flow Mediated Dilation, carotid intima-media thickness, arterial stiffness

  1) Baseline; 2) After seven months of intervention/control; 3) Seven months after completion of intervention/control.

• Variations in brain vascular reactivity as flow and diameter response to CO2 inhalation

  1) Baseline; 2) After seven months of intervention/control; 3) Seven months after completion of intervention/control.

Study Arms (2)

Standard care

NO INTERVENTION

No intervention besides usual care

Cognitive and physical training

ACTIVE COMPARATOR

Patients will undergo the comprehensive program of cognitive and physical training.

Behavioral: Cognitive and Physical training

Interventions

Cognitive and Physical training BEHAVIORAL

Physical training - Three 60-minute session per week. Participants will be divided in groups of 10, supervised by physiotherapists. Physical activity combines aerobic exercises, muscle strengthening, balance improvement, joint flexibility. Once a week the session is replaced by outdoor walking; once a month by dancing. Cognitive training - The program alternates focuses on specific functions and recreational sessions. Each session will be followed by a lesson about cognitive processes (memory, learning, attention, thought), providing tips to overcome difficulties in daily life. Sessions will focus on attention, imagination, spatial memory, categorization; memory for terms, meanings, songs, faces, names; memorization of texts; goal management.

Cognitive and physical training

Eligibility Criteria

• Age: 65 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Age between 65 and 89
• Successful completion of primary school
• MCI, as Mini Mental State Examination score between 20 and 27 and confirmation through neuropsychological examination by a specialist, according to current guidelines.

You may not qualify if:

• Moderate/severe dementia
• Clinical signs of depressive disorder or other primary psychiatric disorders
• Neoplastic diseases
• Neurologic or musculoskeletal deficits barring neuropsychological examination or physical or cognitive training
• Severe heart disease
• End stage renal disease (eGFR\<35 ml/min(1.73 m2)
• Severe chronic obstructive pulmonary disease (COPD) and/or respiratory failure
• Complicated or decompensated diabetes
• Overt peripheral artery disease
• Any inability to successfully complete a brain magnetic resonance scan
• Epilepsy, drug addiction
• Current acute diseases or recent head trauma

Sponsors & Collaborators

• Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy: lead

Study Sites (1)

Institute of Clinical Physiology - National Research Council

Pisa, 56124, Italy

Location

Related Publications (3)

• Sale A, Noale M, Cintoli S, Tognoni G, Braschi C, Berardi N, Maggi S, Maffei L; Train the Brain Consortium. Long-term beneficial impact of the randomised trial 'Train the Brain', a motor/cognitive intervention in mild cognitive impairment people: effects at the 14-month follow-up. Age Ageing. 2023 May 1;52(5):afad067. doi: 10.1093/ageing/afad067.

  PMID: 37167616 DERIVED

• Bruno RM, Stea F, Sicari R, Ghiadoni L, Taddei S, Ungar A, Bonuccelli U, Tognoni G, Cintoli S, Del Turco S, Sbrana S, Gargani L, D'Angelo G, Pratali L, Berardi N, Maffei L, Picano E; Train the Brain Consortium. Vascular Function Is Improved After an Environmental Enrichment Program: The Train the Brain-Mind the Vessel Study. Hypertension. 2018 Jun;71(6):1218-1225. doi: 10.1161/HYPERTENSIONAHA.117.10066. Epub 2018 Apr 9.

  PMID: 29632101 DERIVED

• Tonacci A, Bruno RM, Ghiadoni L, Pratali L, Berardi N, Tognoni G, Cintoli S, Volpi L, Bonuccelli U, Sicari R, Taddei S, Maffei L, Picano E. Olfactory evaluation in Mild Cognitive Impairment: correlation with neurocognitive performance and endothelial function. Eur J Neurosci. 2017 May;45(10):1279-1288. doi: 10.1111/ejn.13565. Epub 2017 Apr 20.

  PMID: 28370677 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Memory Disorders

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurobehavioral Manifestations; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD,PhD

Study Record Dates

• First Submitted: November 8, 2012
• First Posted: November 12, 2012
• Study Start: March 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: March 1, 2016
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

IT (1)