Multidimensional Rehabilitation Programs for Cognitive Impairment in Comorbid Outpatients: a Randomized Controlled Trial

NCT ID: NCT05954741

Last Updated: 2024-10-03

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-29
• Study Completion Date: 2026-01-31

Brief Summary

Dementias secondary to cerebrovascular diseases are of significant epidemiological and clinical relevance. As a result, the management of individuals with comorbid dementia should involve early diagnosis, effective treatment, and patient-centered care planning, both in specialist and in non-specialist settings. It is well known that physical exercise can improve various aspects of health, including resistance, balance, strength, and cognitive functions such as attention and executive performance. However, the efficacy of cognitive rehabilitation is still not definitive and requires further clarification. Preliminary evidence suggests that a combination of cognitive and motor training along with novel technological approaches has the potential to maintain or improve compromised cognitive function more effectively compared to a single intervention. A multidomain intervention could enhance cognitive functioning in elderly individuals with multiple morbidities. In the present study, patients with early neurocognitive impairment based on a vascular disorder or due to multiple etiologies, as defined by the Diagnostic and Statistical Manual of Mental Disorders, 5th Edition, will be screened in an outpatient multidisciplinary setting and subsequently undergo different models of rehabilitation training.

Primary aim of this study:

• Assess the effectiveness of different rehabilitation protocols for improving cognitive functions in patients with comorbid cognitive impairment. Specifically, the investigators will test the effectiveness of three rehabilitation protocols (digital-based cognitive rehabilitation combined with motor rehabilitation, paper-based cognitive rehabilitation combined with motor rehabilitation, and motor rehabilitation alone) by means of a set of multidimensional outcome measures.

Secondary aims:

• evaluating the enhancement of cognitive performance using various cognitive questionnaires categorized by cognitive domains. Additionally, the investigators will examine multidimensional variables such as motor skills, mood and anxiety levels, quality of life, patient adherence to treatment, the role of communication in patient management, caregiver burden, and the usability of digital devices (when utilized).

Conditions

Cognitive Impairment; Dementia; Comorbidities and Coexisting Conditions; Vascular Dementia; Dementia, Mixed

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group 1

Patients with Neurocognitive Disorder with Clinical Dementia Rating Scale score between 0.5 and 1, due to vascular disease or due to multiple etiology), symptoms onset \< 12 months, age between 65 and 80 years of age, and signed informed consent to participate in the study.

Group Type: ACTIVE_COMPARATOR

Motor rehabilitation alone

Intervention Type: OTHER

Participants will undergo motor training consisting of a walking session (20 minutes), balance exercises, postural control exercises, proprioceptive exercises, joint mobilization exercises, and muscle strengthening exercises for a total of 25 minutes. A muscle relaxation session will follow (45 minutes).

Group 2

Patients with Neurocognitive Disorder with Clinical Dementia Rating Scale score between 0.5 and 1, due to vascular disease or due to multiple etiology), symptoms onset \< 12 months, age between 65 and 80 years of age, and signed informed consent to participate in the study.

Group Type: ACTIVE_COMPARATOR

Motor rehabilitation and Cognitive rehabilitation (paper-based)

Intervention Type: OTHER

Group 2 will perform motor training, with an analogous modality of Group 1 (45 minutes) and a standard cognitive intervention, with the execution of cognitive exercises in the domains of attention, memory, executive function, visuo-spatial abilities, space-time orientation, by paper-pencil support (45 minutes per day).

Group 3

Patients with Neurocognitive Disorder with Clinical Dementia Rating Scale score between 0.5 and 1, due to vascular disease or due to multiple etiology), symptoms onset \< 12 months, age between 65 and 80 years of age, and signed informed consent to participate in the study.

Group Type: ACTIVE_COMPARATOR

Motor rehabilitation and cognitive rehabilitation (digital-based)

Intervention Type: OTHER

Group 3 will perform motor training, with an analogous modality of Group 1 (45 minutes) and a digital cognitive intervention, with the execution of cognitive exercises on attention, memory, executive functions, visual-spatial ability, space-time orientation, employing device support (tablet) with interactive exercises presented by specific software (VRRS Home tablet Khymeia Srl) (45 minutes).

Interventions

Motor rehabilitation alone

Participants will undergo motor training consisting of a walking session (20 minutes), balance exercises, postural control exercises, proprioceptive exercises, joint mobilization exercises, and muscle strengthening exercises for a total of 25 minutes. A muscle relaxation session will follow (45 minutes).

Intervention Type: OTHER

Motor rehabilitation and Cognitive rehabilitation (paper-based)

Group 2 will perform motor training, with an analogous modality of Group 1 (45 minutes) and a standard cognitive intervention, with the execution of cognitive exercises in the domains of attention, memory, executive function, visuo-spatial abilities, space-time orientation, by paper-pencil support (45 minutes per day).

Intervention Type: OTHER

Motor rehabilitation and cognitive rehabilitation (digital-based)

Group 3 will perform motor training, with an analogous modality of Group 1 (45 minutes) and a digital cognitive intervention, with the execution of cognitive exercises on attention, memory, executive functions, visual-spatial ability, space-time orientation, employing device support (tablet) with interactive exercises presented by specific software (VRRS Home tablet Khymeia Srl) (45 minutes).

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Age Between 65 and 80 years.
• Neurocognitive Disorder due to vascular disease with Clinical Dementia Rating Scale score between 0.5 and 1, symptoms onset < 12 months.
• Neurocognitive Disorder due to multiple etiology with Clinical Dementia Rating Scale score between 0.5 and 1, symptoms onset < 12 months.

Exclusion Criteria

• Other known neurological conditions involving cognitive functioning (e.g. Parkinson's disease, Multiple Sclerosis, head trauma, alcohol abuse).
• Severe organic instability.
• Neoplasia in progress.
• Severe psychiatric condition.
• Illiteracy.
• Severe perception deficits.
• Severe motor disability.
• Specific intellectual deficit.
• Participation in other forms of training or neurostimulation in the previous 6 months.
• Pharmacological interventions of neurological pertinence in the month before the study.

• Minimum Eligible Age: 65 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istituti Clinici Scientifici Maugeri SpA

OTHER

Sponsor Role: lead

Responsible Party

Cira Fundarò

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

ICS Maugeri - Montescano

Montescano, Pavia, Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Cira Fundarò, MD

Role: CONTACT

cira.fundaro@icsmaugeri.it

+39 0385247268

Facility Contacts

Cira Fundarò, MD

Role: primary

cira.fundaro@icsmaugeri.it

0385247268

References

Fundaro C, Granata N, Traversoni S, Torlaschi V, Maestri R, Maffoni M, Baiardi P, Grossi F, Buonocore M, Gabanelli P, Manera MR, Pierobon A. Multidimensional screening and intervention program for neurocognitive disorder in vascular and multimorbid outpatients: Study protocol for a randomized clinical trial. PLoS One. 2024 Jul 10;19(7):e0306256. doi: 10.1371/journal.pone.0306256. eCollection 2024.

Reference Type: DERIVED

PMID: 38985746 (View on PubMed)

Other Identifiers

2618 - 9.3.2022

Identifier Type: -

Identifier Source: org_study_id