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Cognitive ImpairmentRCTCogRehabNCT05954741

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

A study testing Motor rehabilitation alone, Motor rehabilitation and Cognitive rehabilitation (paper-based) and Motor rehabilitation and cognitive rehabilitation (digital-based) in people with Cognitive Impairment and Dementia, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 years
What is being tested?
Motor rehabilitation alone, Motor rehabilitation and Cognitive rehabilitation (paper-based) and Motor rehabilitation and cognitive rehabilitation (digital-based)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteItaly
Study dates
29 Feb 2024to Jan 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 10Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Italy1 site, 1 recruiting
  • ICS Maugeri - Montescano

    Montescano, Pavia, 27040

    Cira Fundarò, MD, 0385247268, cira.fundaro@icsmaugeri.it

    Recruiting

Other trials in Italy

About this study

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

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:

Read more
  • 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).
Being tested
Motor rehabilitation alone, Motor rehabilitation and Cognitive rehabilitation (paper-based), Motor rehabilitation and cognitive rehabilitation (digital-based)
Keywords
Dementia, Comorbidity, Cognitive rehabilitation, Motor rehabilitation, Digital-based cognitive rehabilitation
Medical subject headings
Cognitive Dysfunction, Dementia, Dementia, Vascular, Mixed Dementias

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Motor rehabilitation aloneOther

    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).

  • Motor rehabilitation and Cognitive rehabilitation (paper-based)Other

    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).

  • Motor rehabilitation and cognitive rehabilitation (digital-based)Other

    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).

Study groups in NCT05954741
Study groupRoleWhat they receive
Group 1Active comparatorPatients 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.
Receives: Other: Motor rehabilitation alone
Group 2Active comparatorPatients 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.
Receives: Other: Motor rehabilitation and Cognitive rehabilitation (paper-based)
Group 3Active comparatorPatients 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.
Receives: Other: Motor rehabilitation and cognitive rehabilitation (digital-based)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

Secondary outcomes (13)
  1. 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.

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  2. 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.

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  3. 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.

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  4. 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).

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  5. 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.

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  6. 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.

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  7. 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.

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  8. 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.

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  9. 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).

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  10. 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.

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  11. 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.

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  12. 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.

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

  13. 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.

    Measured: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2023
  2. Study start29 Feb 2024
  3. Primary completionOct 2025 (estimated)
  4. Study completionJan 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
75 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05954741
Sponsor's protocol ID
2618 - 9.3.2022
Acronym
RCTCogRehab
Status last verified
Oct 2024
First submitted
6 Jul 2023
Last updated
3 Oct 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 38985746

Questions about this trial

What is this clinical trial studying?

A study testing Motor rehabilitation alone, Motor rehabilitation and Cognitive rehabilitation (paper-based) and Motor rehabilitation and cognitive rehabilitation (digital-based) in people with Cognitive Impairment and Dementia, run by Istituti Clinici Scientifici Maugeri SpA at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 3 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Cira Fundarò, MD (+39 0385247268, cira.fundaro@icsmaugeri.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in cognitive performances (time frame: Evaluation performed at baseline (pre-intervention), post-intervention (after 8 weeks) and at follow up (after 3 months).). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05954741, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2024; AzTrials last refreshed its copy on 2 Nov 2026.

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