Exercises for Rehabilitation of COgnition and Lifestyle Enhancement in Patients With Mild Cognitive Impairment

Summary

Mild Cognitive Impairment (MCI) is a clinical condition with a heterogeneous etiology and clinical course characterized by objective cognitive deficits not severe enough to cause clear functional limitations or to warrant a diagnosis of dementia. Since MCI represents a risk factor for progression to various forms of dementia, timely preventive intervention is essential, although outpatient cognitive rehabilitation for this population is still limited by issues related to service accessibility.

This study aims to investigate the effectiveness of a multimodal group cognitive rehabilitation intevention designed to be accessible for patients with MCI and sustainable in clinical practice.

The primary objective of the study is to evaluate the effects of the intervention on cognitive, behavioural, and functional profile of patients with MCI, compared with an active control group. Outcome measures will be collected for all participants at T0 (baseline), T1 (after 12 weeks of intervention), and T2 (3 months after the end of the intervention and approximately 6 months from baseline), in order to assess both short-term and long-term effects of the intervention. The secondary objective is to explore the relationship between changes in outcome measures in the experimental group following the intervention and patients' demographic and clinical characteristics, with the aim of identifying potential predictors of a greater response to the intervention. Treatment accessibility, which guided the study design, will be evaluated though dropout and attendance rates, use of the provided tools and responses to the final satisfaction questionnaire.

The experimental group will receive a multimodal cognitive rehabilitation intervention, including (a) a multi-domain cognitive training and (b) a lifestyle intervention, consisting of psychoeducational sessions on neuroprotective factors and supported by the use of a web-based application accessible via computer and tablet. The intervention program will be delivered in small groups, with two 60-minute sessions per week over 12 weeks. The intervention was designed to enhance accessibility and sustainability by limiting intervention intensity and duration, using technology, and delivering group-based rehabilitation in groups that are not highly homogeneous. This approach is expected to result in a better cost-benefit balance and greater transferability to clinical practice. The control group will receive an informational booklet on neuroprotective factors, including practical daily-life recommendations to reduce risk profiles.

Forty patients with MCI and their informants will be recruited and randomly assigned to the experimental or control group. Participants in the experimental group will be further divided into small subgroups based on the presence of memory impairment.

Conditions

• Mild Cognitive Impairment (MCI)

Interventions

BEHAVIORAL

Multimodal Group Cognitive Rehabilitation Intervention

The multimodal Group Cognitive Rehabilitation Intervention included a multi-domain cognitive training and a lifestyle intervention. The exercise package adopted in the multi-domain cognitive training will be adapted from that used in a previous cognitive enhancement study by Tagliabue and colleagues (2018) conducted in neurologically healthy adults over 60. The lifestyle intervention will consist of psychoeducational sessions on neuroprotective factor and supported by the use of a web-based application accessible via computer and tablet. The intervention program will be delivered in small groups formed according to the presence of memory impairment, with two 60-minute sessions per week for a total of 12 weeks.

BEHAVIORAL

Active Control

The control group will receive an informational booklet on the 14 protective factors for dementia described by the Lancet Commission in 2024, including practical daily-life recommendations to reduce risk. An ad hoc questionnaire will be administered to the patients assigned to the control condition and to one of their family members every two weeks for a period of 12 weeks, in order to monitor patients' efforts and progress in following the recommendations provided.

Sponsors & Collaborators

• University of Milano Bicocca

  collaborator OTHER

• Casa di Cura IGEA

  lead OTHER

Principal Investigators

• Sabrina Guzzetti · Casa di Cura Igea, Milano

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

50 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-02-16

Primary Completion

2027-05-31

Completion

2027-05-31

Countries

• Italy

Study Locations