Actively Recruiting

Phase Not Applicable
Age: 65Years - 80Years
All Genders
NCT05954741

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

Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2024-10-03

75

Participants Needed

1

Research Sites

96 weeks

Total Duration

On this page

AI-Summary

What this Trial Is 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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 65Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age between 65 and 80 years
  • Neurocognitive disorder due to vascular disease with Clinical Dementia Rating Scale score between 0.5 and 1
  • Symptom onset less than 12 months for vascular neurocognitive disorder
  • Neurocognitive disorder due to multiple etiologies with Clinical Dementia Rating Scale score between 0.5 and 1
  • Symptom onset less than 12 months for multiple etiology neurocognitive disorder
Not Eligible

You will not qualify if you...

  • Other neurological conditions affecting cognition (e.g., Parkinson's disease, Multiple Sclerosis, head trauma, alcohol abuse)
  • Severe organic instability
  • Active cancer (neoplasia in progress)
  • Severe psychiatric conditions
  • Illiteracy
  • Severe perception deficits
  • Severe motor disability
  • Specific intellectual deficits
  • Participation in other training or neurostimulation within the last 6 months
  • Neurological pharmacological treatments within 1 month before the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

ICS Maugeri - Montescano

Montescano, Pavia, Italy, 27040

Actively Recruiting

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Research Team

C

Cira Fundarò, MD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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