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

NCT05954741 | Recruiting

• 1 other identifier: 2618 - 9.3.2022
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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

Keywords

Dementia; Comorbidity; Cognitive rehabilitation; Motor rehabilitation; Digital-based cognitive rehabilitation

Outcome Measures

Primary Outcomes (1)

• Changes in cognitive performances

  Mini Mental State Examination (Foderaro, 2022; Carpinelli Mazzi, 2020). Evaluation of various cognitive domains by answering 30 items (spatial/temporal orientation, repetition and recall of three words, working memory - backward calculation and/or spelling -, sentence repetition, sentence writing, naming, three-step command execution, constructional praxis).

  Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

Secondary Outcomes (13)

• Changes in attention performance

  Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

• Changes in motor performance

  Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

• Changes in Basic Activities of Daily Living

  Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

• Changes in Instrumental Activities of Daily Living

  Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

• Changes in Anxious Symptoms

  Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

Study Arms (3)

Group 1

ACTIVE COMPARATOR

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.

Other: Motor rehabilitation alone

Group 2

ACTIVE COMPARATOR

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.

Other: Motor rehabilitation and Cognitive rehabilitation (paper-based)

Group 3

ACTIVE COMPARATOR

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.

Other: Motor rehabilitation and cognitive rehabilitation (digital-based)

Interventions

Motor rehabilitation alone 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 1

Motor rehabilitation and Cognitive rehabilitation (paper-based) 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 2

Motor rehabilitation and cognitive rehabilitation (digital-based) 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).

Group 3

Eligibility Criteria

• Age: 65 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituti Clinici Scientifici Maugeri SpA: lead

Study Sites (1)

ICS Maugeri - Montescano

Montescano, Pavia, 27040, Italy

RECRUITING

Related Publications (1)

• 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.

  PMID: 38985746 DERIVED

MeSH Terms

Conditions

Cognitive Dysfunction; Dementia; Dementia, Vascular; Mixed Dementias

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Cerebrovascular Disorders; Intracranial Arteriosclerosis; Intracranial Arterial Diseases; Leukoencephalopathies; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Central Study Contacts

Cira Fundarò, MD

CONTACT

+39 0385247268; cira.fundaro@icsmaugeri.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: July 6, 2023
• First Posted: July 20, 2023
• Study Start: February 29, 2024
• Primary Completion: October 1, 2025
• Study Completion: January 1, 2026
• Last Updated: October 3, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)