Clinical trial NCT05954741: Multidimensional Rehabilitation Programs for Cognitive Impairment in Comorbid Outpatients: a Randomized Controlled Trial
Official title: Comparing the Effectiveness of Multidimensional Rehabilitation Programs for Cognitive Impairment in Comorbid Outpatients: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cognitive Impairment
Dementia
Comorbidities and Coexisting Conditions
Vascular Dementia
Dementia, Mixed
Keywords: Dementia
Comorbidity
Cognitive rehabilitation
Motor rehabilitation
Digital-based cognitive rehabilitation
Lead sponsor: Istituti Clinici Scientifici Maugeri SpA
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 75
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Primary outcomes:
measure: Changes in cognitive performances
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
Secondary outcomes:
measure: Changes in attention performance
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in motor performance
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in Basic Activities of Daily Living
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in Instrumental Activities of Daily Living
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in Anxious Symptoms
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in Depressive Symptoms
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in Neuropsychiatric Symptoms
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in Caregiver Burden
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in Health-Related Quality of Life (Questionnaire)
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in Health-Related Quality of Life (Visual Analogue Scale)
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in Treatment Adherence
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in HealthCare Communication
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
measure: Changes in System Usability (for Group 3 exclusively)
timeFrame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
Other outcomes:
Locations:
city: Montescano
country: Italy
facility: ICS Maugeri - Montescano
state: Pavia
Study officials:
References: