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

Primary Purpose

Cognitive Impairment, Dementia, Comorbidities and Coexisting Conditions

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Motor rehabilitation alone
Motor rehabilitation and Cognitive rehabilitation (paper-based)
Motor rehabilitation and cognitive rehabilitation (digital-based)
Sponsored by
Istituti Clinici Scientifici Maugeri SpA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Impairment focused on measuring Dementia, Comorbidity, Cognitive rehabilitation, Motor rehabilitation, Digital-based cognitive rehabilitation

Eligibility Criteria

65 Years - 80 Years (Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Active Comparator

    Active Comparator

    Active Comparator

    Arm Label

    Group 1

    Group 2

    Group 3

    Arm Description

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Changes in cognitive performances
    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).

    Secondary Outcome Measures

    Changes in attention performance
    Assessed by Trail Making Test-A, which evaluates visuospatial skills, psychomotor speed, and selective attention. In Trail Making Test A, the subject must join all 25 numbers on the sheet in ascending order in the shortest possible time.
    Changes in motor performance
    Assessed by Timed Up and Go test (TUG) (Podsiadlo & Richardson, 1991). It is a functional test to assess fall risk and static and dynamic balance. The patient is timed and asked to stand up from a chair, walk three meters, turn around, walk to the chair, and sit down. The cut-off on the total time taken in the test varies according to the clinical population observed. 6 minute walking test will be also administered ("ATS Statement: Guidelines for the Six-Minute Walk Test.," 2002). It is a simple test usually employed for assessing response to therapy in patients with pulmonary and cardiovascular disease. The test consists in walking autonomously (or held by an operator, if necessary) in a straight corridor for 6 minutes. Once the test is over, the distance traveled is calculated.
    Changes in Basic Activities of Daily Living
    The Basic Activity of Daily Living (BADL) (Katz et al., 1963) is a scale for assessing basic activities related to everyday living. The scale proposes 6 basic activities (bathing; dressing; toileting; continence; moving; feeding). At the end of the assignment, the total score is calculated by summing all the points from each item.
    Changes in Instrumental Activities of Daily Living
    The Instrumental Activity of Daily Living (IADL) (Lawton & Brody, 1969). It is used to assess the levels of autonomy in life activities (basic and instrumental) of the patient by the caregiver. Thus, 8 complex functions are reported (using the telephone; shopping; using transportation; cooking (women only); doing housework (women only); doing laundry (women only); handling money; taking medications).
    Changes in Anxious Symptoms
    The Generalized Anxiety Disorder-7 (GAD) (Spitzer et al., 2006) is a questionnaire built to measure the severity of anxiety symptoms in the previous two weeks.
    Changes in Depressive Symptoms
    The Patient Health Questionnaire-9 (PHQ-9) (Spitzer et al., 1999) is a scale currently used in general practice to determine the diagnosis, severity, and subsequent monitoring of depressive conditions in patients.
    Changes in Neuropsychiatric Symptoms
    The Neuropsychiatric Inventory NPI-Q (Kaufer et al., 2000) is a self-report questionnaire administered to the caregiver in order to assess the occurrence and severity of a range of neuropsychiatric symptoms in the patient during the past few weeks.
    Changes in Caregiver Burden
    The Family Strain Questionnaire (FSQ) - Short Form (FSQ-SF) (Ferrario et al., 2004) is a screening tool that aims to gather information on the situation experienced by a primary caregiver in the care setting, such as emotional overload, and organizes its scores according to areas of increasing criticality.
    Changes in Health-Related Quality of Life (Questionnaire)
    The EuroQol 5D-5L (Rabin & de Charro, 2009). It is a questionnaire consisting of 5 sections (motor abilities; personal care; usual activities; pain; anxiety and depression) and provides the option to select a level of severity (1, no problem; 2, moderate problem; 3, severe problem).
    Changes in Health-Related Quality of Life (Visual Analogue Scale)
    The EuroQol 5D-5L - VAS (Rabin & de Charro, 2009). The EuroQoL Visual Analogue Scale (EQ VAS) consists of a visual analogue scale from 0 (Worst imaginable health state) to 100 (Best imaginable health state), where the subject is asked to indicate the level of self-perceived wellness.
    Changes in Treatment Adherence
    The Morisky Green Levine (MGL) Adherence Scale (Morisky et al., 1986) is a rapidly administered questionnaire widely used to assess nonadherence to medication prescriptions. Its 4-item version consists of 4 questions with strictly behavioral content that can be answered in binary form (yes/no). The content of the questions varies from forgetfulness and inattention in taking the medication to autonomous discontinuation of the prescription without the doctor's permission.
    Changes in HealthCare Communication
    The Communication Assessment Tool (CAT) (Scala et al., 2016) is a 15-item questionnaire created to assess patients' perceptions of the physician's communication effectiveness. Patients are asked to respond based on a single encounter with the physician.
    Changes in System Usability (for Group 3 exclusively)
    Changes in System Usability will be addressed with the SUS scale. The System Usability Scale (SUS) (Kortum et al., 2020) consists in a self-reported assessment of the degree of perceived usability as a result of using a wide variety of devices and systems. The higher the scores, the higher the degree of perceived usability. The score ranges from A=excellent usability to F=poor usability based on the normal distribution of the percentile range of mean scores: A = >80.3; B = 80.3-68; C = 68; D = 67-51; F = <51. It consists of 10 items on a 5-point Likert scale (1=not at all agree; 5=fully agree). The range for scoring each item is 0-4. The total scores are between 0 and 100 and are obtained by subtracting the raw scores at items 1, 3, 5, 7, and 9 by one, while the raw scores at items 2, 4, 6, 8, and 10 will be subtracted from 5. The adjusted scores are added together and the total sum is multiplied by 2.5, thus obtaining the total score.

    Full Information

    First Posted
    July 6, 2023
    Last Updated
    July 13, 2023
    Sponsor
    Istituti Clinici Scientifici Maugeri SpA
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05954741
    Brief Title
    Multidimensional Rehabilitation Programs for Cognitive Impairment in Comorbid Outpatients: a Randomized Controlled Trial
    Acronym
    RCTCogRehab
    Official Title
    Comparing the Effectiveness of Multidimensional Rehabilitation Programs for Cognitive Impairment in Comorbid Outpatients: a Randomized Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    October 2023 (Anticipated)
    Primary Completion Date
    October 2025 (Anticipated)
    Study Completion Date
    January 2026 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Istituti Clinici Scientifici Maugeri SpA

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cognitive Impairment, Dementia, Comorbidities and Coexisting Conditions, Vascular Dementia, Dementia, Mixed
    Keywords
    Dementia, Comorbidity, Cognitive rehabilitation, Motor rehabilitation, Digital-based cognitive rehabilitation

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group 1
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group 2
    Arm Type
    Active Comparator
    Arm Description
    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.
    Arm Title
    Group 3
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Motor rehabilitation alone
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Motor rehabilitation and Cognitive rehabilitation (paper-based)
    Intervention Description
    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).
    Intervention Type
    Other
    Intervention Name(s)
    Motor rehabilitation and cognitive rehabilitation (digital-based)
    Intervention Description
    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).
    Primary Outcome Measure Information:
    Title
    Changes in cognitive performances
    Description
    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).
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Secondary Outcome Measure Information:
    Title
    Changes in attention performance
    Description
    Assessed by Trail Making Test-A, which evaluates visuospatial skills, psychomotor speed, and selective attention. In Trail Making Test A, the subject must join all 25 numbers on the sheet in ascending order in the shortest possible time.
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in motor performance
    Description
    Assessed by Timed Up and Go test (TUG) (Podsiadlo & Richardson, 1991). It is a functional test to assess fall risk and static and dynamic balance. The patient is timed and asked to stand up from a chair, walk three meters, turn around, walk to the chair, and sit down. The cut-off on the total time taken in the test varies according to the clinical population observed. 6 minute walking test will be also administered ("ATS Statement: Guidelines for the Six-Minute Walk Test.," 2002). It is a simple test usually employed for assessing response to therapy in patients with pulmonary and cardiovascular disease. The test consists in walking autonomously (or held by an operator, if necessary) in a straight corridor for 6 minutes. Once the test is over, the distance traveled is calculated.
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in Basic Activities of Daily Living
    Description
    The Basic Activity of Daily Living (BADL) (Katz et al., 1963) is a scale for assessing basic activities related to everyday living. The scale proposes 6 basic activities (bathing; dressing; toileting; continence; moving; feeding). At the end of the assignment, the total score is calculated by summing all the points from each item.
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in Instrumental Activities of Daily Living
    Description
    The Instrumental Activity of Daily Living (IADL) (Lawton & Brody, 1969). It is used to assess the levels of autonomy in life activities (basic and instrumental) of the patient by the caregiver. Thus, 8 complex functions are reported (using the telephone; shopping; using transportation; cooking (women only); doing housework (women only); doing laundry (women only); handling money; taking medications).
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in Anxious Symptoms
    Description
    The Generalized Anxiety Disorder-7 (GAD) (Spitzer et al., 2006) is a questionnaire built to measure the severity of anxiety symptoms in the previous two weeks.
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in Depressive Symptoms
    Description
    The Patient Health Questionnaire-9 (PHQ-9) (Spitzer et al., 1999) is a scale currently used in general practice to determine the diagnosis, severity, and subsequent monitoring of depressive conditions in patients.
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in Neuropsychiatric Symptoms
    Description
    The Neuropsychiatric Inventory NPI-Q (Kaufer et al., 2000) is a self-report questionnaire administered to the caregiver in order to assess the occurrence and severity of a range of neuropsychiatric symptoms in the patient during the past few weeks.
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in Caregiver Burden
    Description
    The Family Strain Questionnaire (FSQ) - Short Form (FSQ-SF) (Ferrario et al., 2004) is a screening tool that aims to gather information on the situation experienced by a primary caregiver in the care setting, such as emotional overload, and organizes its scores according to areas of increasing criticality.
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in Health-Related Quality of Life (Questionnaire)
    Description
    The EuroQol 5D-5L (Rabin & de Charro, 2009). It is a questionnaire consisting of 5 sections (motor abilities; personal care; usual activities; pain; anxiety and depression) and provides the option to select a level of severity (1, no problem; 2, moderate problem; 3, severe problem).
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in Health-Related Quality of Life (Visual Analogue Scale)
    Description
    The EuroQol 5D-5L - VAS (Rabin & de Charro, 2009). The EuroQoL Visual Analogue Scale (EQ VAS) consists of a visual analogue scale from 0 (Worst imaginable health state) to 100 (Best imaginable health state), where the subject is asked to indicate the level of self-perceived wellness.
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in Treatment Adherence
    Description
    The Morisky Green Levine (MGL) Adherence Scale (Morisky et al., 1986) is a rapidly administered questionnaire widely used to assess nonadherence to medication prescriptions. Its 4-item version consists of 4 questions with strictly behavioral content that can be answered in binary form (yes/no). The content of the questions varies from forgetfulness and inattention in taking the medication to autonomous discontinuation of the prescription without the doctor's permission.
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in HealthCare Communication
    Description
    The Communication Assessment Tool (CAT) (Scala et al., 2016) is a 15-item questionnaire created to assess patients' perceptions of the physician's communication effectiveness. Patients are asked to respond based on a single encounter with the physician.
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).
    Title
    Changes in System Usability (for Group 3 exclusively)
    Description
    Changes in System Usability will be addressed with the SUS scale. The System Usability Scale (SUS) (Kortum et al., 2020) consists in a self-reported assessment of the degree of perceived usability as a result of using a wide variety of devices and systems. The higher the scores, the higher the degree of perceived usability. The score ranges from A=excellent usability to F=poor usability based on the normal distribution of the percentile range of mean scores: A = >80.3; B = 80.3-68; C = 68; D = 67-51; F = <51. It consists of 10 items on a 5-point Likert scale (1=not at all agree; 5=fully agree). The range for scoring each item is 0-4. The total scores are between 0 and 100 and are obtained by subtracting the raw scores at items 1, 3, 5, 7, and 9 by one, while the raw scores at items 2, 4, 6, 8, and 10 will be subtracted from 5. The adjusted scores are added together and the total sum is multiplied by 2.5, thus obtaining the total score.
    Time Frame
    Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    65 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Cira Fundarò, MD
    Phone
    +39 0385247268
    Email
    cira.fundaro@icsmaugeri.it

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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

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