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

NCT06755164 | Active Not Recruiting DMC

• 1 other identifier: aMCI SIM-SEQ
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Neurorehabilitation; cognitive training; aerobic training; combined training; cognitive rehabilitation; episodic memory; mild cognitive impairment

Outcome Measures

Primary Outcomes (1)

• Episodic memory improvement

  The primary aim of the study is to investigate episodic memory improvement (investigated with changes in the Alzheimer's Disease Assessment Scale (ADAS-cog scale), both in short- (sooner after training) and in long-term (6 months after training). ADAS-Cog scale is a useful tool which is widely employed to assess global cognitive functioning in patients with several neurodegenerative conditions including MCI. Range score is from 0 to 70. Lower scores indicate better performance.

  Baseline, month 3, month 9

Secondary Outcomes (11)

• Functional MRI changes

  Baseline, month 3

• Changes in submaximal aerobic/functional walking capacity

  Baseline, month 3, month 9

• Mood changes

  Baseline, month 3, month 9

• Quality of life changes

  Baseline, month 3, month 9

• Inflammatory cytokines changes

  Baseline, month 3, month 9

Study Arms (2)

SIM (simultaneous aerobic and cognitive training)

EXPERIMENTAL

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).

Other: Simultaneous aerobic and cognitive training (SIM)

SEQ (sequential aerobic and cognitive training)

EXPERIMENTAL

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

Other: Sequential aerobic and cognitive training (SEQ)

Interventions

Simultaneous aerobic and cognitive training (SIM) OTHER

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.

SIM (simultaneous aerobic and cognitive training)

Sequential aerobic and cognitive training (SEQ) OTHER

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.

SEQ (sequential aerobic and cognitive training)

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• patients who are used to do regular physical and/or cognitive activity;
• 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).

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Sites (1)

IRCCS San Raffaele

Milan, MI, 20132, Italy

Location

Related Publications (16)

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MeSH Terms

Conditions

Cognitive Dysfunction; Neurodegenerative Diseases

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neurological Rehabilitation; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Blinding will be maintained for allocation concealment, which will be carried out through closed and opaque mails by a blind operator. Patients will be labelled with a numerical code to ensure anonymisationPatients, assessors (neurologists, neuropsychologists and physiotherapists who will evaluate patient inclusion in the study) and statisticians will be blind to allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof.

Model Details: This study is a national, monocentric, double-blind, randomized, controlled, comparative, multi-parametric and parallel-group trial. Patients with a diagnosis of aMCI will be screened to establish eligibility for participation. Once enrolled, participants will be randomized through random.org software in the two experimental groups: 1) SIM (simultaneous) and 2) SEQ (sequential) aerobic-cognitive training. Allocation concealment will be carried out through closed and opaque mails by a blind operator. All patients will undergo the combined training for 3 months, with sessions scheduled twice a week, lasting 70 minutes each.

Study Record Dates

• First Submitted: December 13, 2024
• First Posted: January 1, 2025
• Study Start: April 5, 2019
• Primary Completion: January 16, 2024
• Study Completion: February 28, 2025
• Last Updated: January 10, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)