Comparing the Effectiveness of Multidimensional Rehabilitation Programs for Cognitive Impairment in Comorbid Outpatients: a Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 75
- 试验地点
- 1
- 主要终点
- Changes in cognitive performances
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 65 Years 至 80 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Group 1
Patients with Neurocognitive Disorder with Clinical Dementia Rating Scale score between 0.5 and 1, due to vascular disease or due to multiple etiology), symptoms onset < 12 months, age between 65 and 80 years of age, and signed informed consent to participate in the study.
干预措施: Motor rehabilitation alone (Other)
Group 2
Patients with Neurocognitive Disorder with Clinical Dementia Rating Scale score between 0.5 and 1, due to vascular disease or due to multiple etiology), symptoms onset < 12 months, age between 65 and 80 years of age, and signed informed consent to participate in the study.
干预措施: Motor rehabilitation and Cognitive rehabilitation (paper-based) (Other)
Group 3
Patients with Neurocognitive Disorder with Clinical Dementia Rating Scale score between 0.5 and 1, due to vascular disease or due to multiple etiology), symptoms onset < 12 months, age between 65 and 80 years of age, and signed informed consent to participate in the study.
干预措施: Motor rehabilitation and cognitive rehabilitation (digital-based) (Other)
结局指标
主要结局
Changes in cognitive performances
时间窗: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
Mini Mental State Examination (Foderaro, 2022; Carpinelli Mazzi, 2020). Evaluation of various cognitive domains by answering 30 items (spatial/temporal orientation, repetition and recall of three words, working memory - backward calculation and/or spelling -, sentence repetition, sentence writing, naming, three-step command execution, constructional praxis).
次要结局
- Changes in attention performance(Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).)
- Changes in motor performance(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(Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).)
- Changes in Anxious Symptoms(Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).)
- Changes in Caregiver Burden(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)(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)(Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).)
- Changes in System Usability (for Group 3 exclusively)(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(Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).)
- Changes in Treatment Adherence(Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).)
- Changes in HealthCare Communication(Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).)
- Changes in Neuropsychiatric Symptoms(Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).)
- Changes in Depressive Symptoms(Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).)
研究者
Cira Fundarò
Principal investigator
Istituti Clinici Scientifici Maugeri SpA