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

Istituti Clinici Scientifici Maugeri SpA

Status: Enrolling

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

Treatments: Other: Motor rehabilitation and cognitive rehabilitation (digital-based); Other: Motor rehabilitation and Cognitive rehabilitation (paper-based); Other: Motor rehabilitation alone

Study type: Interventional

Funder types: Other

Identifiers

NCT05954741

2618 - 9.3.2022

Details and patient eligibility

About

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).

Enrollment: 75 estimated patients

Sex: All

Ages: 65 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Group 1

Active Comparator group

Description:

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.

Treatment:

Other: Motor rehabilitation alone

Group 2

Active Comparator group

Description:

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.

Treatment:

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

Group 3

Active Comparator group

Description:

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.

Treatment:

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