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

Официальное название

Comparing the Effectiveness of Multidimensional Rehabilitation Programs for Cognitive Impairment in Comorbid Outpatients: a Randomized Controlled Trial

Обзор

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).

Вмешательства

• Другое Motor rehabilitation alone
  Participants will undergo motor training consisting of a walking session (20 minutes), balance exercises, postural control exercises, proprioceptive exercises, joint mobilization exercises, and muscle strengthening exercises for a total of 25 minutes. A muscle relaxation session will follow (45 minutes).
• Другое Motor rehabilitation and Cognitive rehabilitation (paper-based)
  Group 2 will perform motor training, with an analogous modality of Group 1 (45 minutes) and a standard cognitive intervention, with the execution of cognitive exercises in the domains of attention, memory, executive function, visuo-spatial abilities, space-time orientation, by paper-pencil support (45 minutes per day).
• Другое Motor rehabilitation and cognitive rehabilitation (digital-based)
  Group 3 will perform motor training, with an analogous modality of Group 1 (45 minutes) and a digital cognitive intervention, with the execution of cognitive exercises on attention, memory, executive functions, visual-spatial ability, space-time orientation, employing device support (tablet) with interactive exercises presented by specific software (VRRS Home tablet Khymeia Srl) (45 minutes).

Первичные конечные точки

• Changes in cognitive performances [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]

Вторичные конечные точки (12)

• Changes in attention performance [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]
• Changes in motor performance [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]
• Changes in Basic Activities of Daily Living [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]
• Changes in Instrumental Activities of Daily Living [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]
• Changes in Anxious Symptoms [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]
• Changes in Depressive Symptoms [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]
• Changes in Neuropsychiatric Symptoms [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]
• Changes in Caregiver Burden [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]
• Changes in Health-Related Quality of Life (Questionnaire) [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]
• Changes in Health-Related Quality of Life (Visual Analogue Scale) [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]
• Changes in Treatment Adherence [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]
• Changes in HealthCare Communication [Срок оценки: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Профилактика

Центры проведения

Италия · 1 центр

• ICS Maugeri - Montescano — Montescano

Публикации

• Fundaro C, Granata N, Traversoni S, Torlaschi V, Maestri R, Maffoni M, Baiardi P, Grossi F, Buonocore M, Gabanelli P, Manera MR, Pierobon A. Multidimensional screening and intervention program for neurocognitive disorder in vascular and multimorbid outpatients: Study protocol for a randomized clinical trial. PLoS One. 2024 Jul 10;19(7):e0306256. doi: 10.1371/journal.pone.0306256. eCollection 2024. PMID 38985746

Идентификаторы

NCT: NCT05954741 · 2618 - 9.3.2022

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗