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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65-80
SponsorIstituti Clinici Scientifici Maugeri SpA

About this 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:

\- 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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Motor rehabilitation alone

    Other intervention

    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 intervention

    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 intervention

    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).

Treatment groups

75 Participants
are divided into 3 treatment groups
Group A: Group 1Active comparator 1 intervention
Group B: Group 2Active comparator 1 intervention
Group C: Group 3Active comparator 1 intervention

Trial outcomes

Primary outcomes

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).

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

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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).

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

Other outcomes

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