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

Study acronym: RCTCogRehab
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 3, 2024 (before its estimated October 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Notable Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    • Start date changed from estimate of May 2024 to Feb 29, 2024
    v3
  2. Notable Start date: Oct 2023 to May 2024v2
  3. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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).
Trial Details
NCT Number NCT05954741
Lead Sponsor Istituti Clinici Scientifici Maugeri SpA
Conditions
(from sponsor)
Cognitive Impairment, Dementia, Comorbidities and Coexisting Conditions, Vascular Dementia, Dementia, Mixed
Related terms Cognitive Dysfunction, Dementia, Dementia, Vascular, Mixed Dementias
Enrollment 75 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov