NCT05954741 Multidimensional Rehabilitation Programs for Cognitive Impairment in Comorbid Outpatients: a Randomized Controlled Trial
| NCT ID | NCT05954741 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Istituti Clinici Scientifici Maugeri SpA |
| Condition | Cognitive Impairment |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2024-02-29 |
| Primary Completion | 2025-10 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 75 participants in total. It began in 2024-02-29 with a primary completion date of 2025-10.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05954741 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, up to 80 Years, studying Cognitive Impairment. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05954741 currently recruiting?
Yes, NCT05954741 is actively recruiting participants. Contact the research team at cira.fundaro@icsmaugeri.it for enrollment information.
Where is the NCT05954741 trial being conducted?
This trial is being conducted at Montescano, Italy.
Who is sponsoring the NCT05954741 clinical trial?
NCT05954741 is sponsored by Istituti Clinici Scientifici Maugeri SpA. The trial plans to enroll 75 participants.