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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

NCT06755164 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2025-01-10

No results posted yet for this study

Summary

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.

Conditions

  • Mild Cognitive Impairment (MCI)
  • AMCI - Amnestic Mild Cognitive Impairment
  • Neurodegenerative Dementia
  • Neurodegenerative Disease

Interventions

OTHER

Simultaneous aerobic and cognitive training (SIM)

The SIMULTANEOUS Group (SIM) will undergo15 minutes of stretching and preparatory mobilization + 40 minutes of cyclette (5 minutes warm-up, 30 minutes aerobic and cognitive training, 5 minutes cool-down) + 15 minutes of mobilization and deep breathing (total: 70 minutes). Patients will perform the cognitive training sited on the cyclette using an adapted computer screen and a joystick.

OTHER

Sequential aerobic and cognitive training (SEQ)

The SEQUENTIAL Group (SEQ) will undergo 40 minutes of cyclette (5 minutes warm-up, 30 minutes aerobic training, 5 minutes cool-down), + 30 minutes of cognitive training (total: 70 minutes). Patients will perform the cognitive training after the aerobic training, sited on a desk using a computer and a joystick.

Sponsors & Collaborators

  • IRCCS San Raffaele

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-04-05
Primary Completion
2024-01-16
Completion
2025-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06755164 on ClinicalTrials.gov