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Effects of Combined Aerobic and Cognitive Training in a Simultaneous or Sequential Paradigm on Cognition and Brain Functional Activity in Patients with AMCI

A legfontosabb adatok

Ki végzi
IRCCS San Raffaele
Hol
Olaszország1 helyszín, 1 országbanVálassz országot a helyszínekhez
Azonosító
Állapot
Fut, nem toboroz
Résztvevők
55 fő, tervezett
Kezdés
2019. ápr. 5.
Befejezés
2025. febr. 28.
A vizsgálat típusa
Beavatkozással járó, 2 csoport
A vizsgált kezelések
  • Simultaneous aerobic and cognitive training (SIM)
  • Sequential aerobic and cognitive training (SEQ)
A regiszteradat frissítve
2025. január 10.

Ki vehet részt

Életkor
60 év felett
Nem
Nők és férfiak
Egészséges önkéntesek
Részt vehetnek

A regiszter feltételei, szó szerint

Mind a 9 feltétel megnézéseKevesebb

Ki vehet részt

  • a diagnosis of amnesic mild cognitive impairment according to the current diagnostic criteria
  • age>60 years
  • stable acetylcholinesterase inhibitors and/or memantine at the time of enrolment for at least one month
  • subscription of the consent for personal data treatment and patients' informed consent for participation in the present study

Ki nem vehet részt

  • patients with a history of other systemic, neurologic, psychiatric diseases, head injury, cardiovascular events, and cerebrovascular alterations visible at an MRI scan
  • patients with a family history of neurodegenerative disorders
  • patients with a history of alcohol and/or psychotropic drugs abuse
  • contraindication to perform MRI scan (cardiac pace-maker or other types of cardiac catheters, splinters or metallic shards, metallic prosthesis not compatible with magnetic field generated by MRI, claustrophobia, pregnancy, breastfeeding)
  • patients who are used to do regular physical and/or cognitive activity

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A vizsgálatról

Mit akar kideríteni a vizsgálat

Mild Cognitive Impairment (MCI) is a condition in which patients show an objective evidence of impairment in one or more cognitive domains but a spared independence in daily functional abilities. The cognitive domain which results to be the most impaired defines the clinical subtype. Specifically, the amnestic subtype of MCI (aMCI), which is the most frequent, is characterised by deficits in episodic memory and visuospatial abilities. Current literature reports that prompt and focused rehabilitation provided early in the disease course might slow down the development of the neurodegenerative condition. The coupling between cognitive and aerobic trainings is the most incisive non-pharmacological treatment, and its effects have been demonstrated to have an impact on global cognitive functions, quality of life, aerobic capacity, and mood in the elderly with aMCI. However, the best modality for coupling aerobic and cognitive trainings (i.e., whether sequential-SEQ: aerobic training followed by cognitive training; or simultaneous-SIM: cognitive training during aerobic training) is still unknown. The aim of the present study is to determine which modality, among SEQ or SIM, is the most incisive training in patients with aMCI. Using a Randomized Controlled design, the effect of this combined aerobic-cognitive non-pharmachological training in both modalities will be evaluated on cognitive changes assessed with standard and computerized neuropsychological batteries and in functional activity during a task-based functional Magnetic Resonance Imaging (fMRI) scan.

A vizsgálat 2 csoportja

  • SIM (simultaneous aerobic and cognitive training)A vizsgált kezelés

    In the SIMULTANEOUS Group (SIM), the aerobic and cognitive training will be performed simultaneously (i.e. the cognitive training will be performed during the aerobic training).

    Kezelés: Simultaneous aerobic and cognitive training (SIM)

  • SEQ (sequential aerobic and cognitive training)A vizsgált kezelés

    In the SEQUENTIAL Group (SEQ), the aerobic and cognitive training will be performed sequentially (i.e. the cognitive training will follow the aerobic training).

    Kezelés: Sequential aerobic and cognitive training (SEQ)

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
Effects of Combined Aerobic and Cognitive Training in a Simultaneous or Sequential Paradigm on Cognition and Brain Functional Activity in Patients with Amnesic Mild Cognitive Impairment
A regiszteradat frissítve
2025. január 10.