Actively Recruiting

Phase Not Applicable
Age: 65Years - 80Years
All Genders
ID05954741

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

Led by Istituti Clinici Scientifici Maugeri SpA · Updated on 2024-10-03

75

Participants Needed

1

Research Sites

13 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying cognitive impairment and dementia caused by vascular diseases or multiple causes in older adults. The study aims to evaluate the effectiveness of three different rehabilitation programs combining cognitive and motor training to improve cognitive functions. This research is important because physical exercise has shown benefits for health and cognition, but the role of cognitive rehabilitation is not yet clear, especially when combined with new technologies. The trial compares three groups: one receiving only motor rehabilitation, one receiving motor rehabilitation plus paper-based cognitive exercises, and one receiving motor rehabilitation plus digital cognitive exercises using a tablet. Each intervention includes sessions focused on walking, balance, strength, and cognitive tasks covering attention, memory, and executive functions. Treatments last for 8 weeks. Participants will be evaluated before and after the 8-week intervention and again after 3 months. Researchers will assess cognitive performance, attention, motor skills, mood, daily living activities, quality of life, treatment adherence, communication, caregiver burden, and usability of digital tools when applicable. The total study participation spans approximately 3 months, including follow-up assessments to monitor changes and safety.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 65Years - 80Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age Between 65 and 80 years.
  • Diagnosed with Neurocognitive Disorder due to vascular disease with Clinical Dementia Rating Scale score between 0.5 and 1.
  • Diagnosed with Neurocognitive Disorder due to multiple etiologies with Clinical Dementia Rating Scale score between 0.5 and 1.
  • Symptoms onset less than 12 months.
  • Signed informed consent to participate.
Not Eligible

You will not qualify if you...

  • Other neurological conditions affecting cognitive function (e.g., Parkinson's disease, Multiple Sclerosis, head trauma, alcohol abuse).
  • Severe organic instability.
  • Active cancer.
  • Severe psychiatric conditions.
  • Illiteracy.
  • Severe perception deficits.
  • Severe motor disabilities.
  • Specific intellectual deficits.
  • Participation in training or neurostimulation in the previous 6 months.
  • Neurological medications started within one month before the study.

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 8 weeks

Participants undergo multidimensional rehabilitation programs including motor rehabilitation alone or combined with cognitive rehabilitation, delivered through paper-based or digital exercises.

Weekly visits for up to 8 weeks

Follow-up

Duration - 3 months

Participants are monitored to evaluate the lasting effects of the rehabilitation programs on cognitive and motor performance, daily living activities, and psychological symptoms.

1 follow-up visit (in-person)

Trial Site Locations

Total: 1 location

1

ICS Maugeri - Montescano

Montescano, Pavia, Italy, 27040

Actively Recruiting

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Research Team

C

Cira Fundarò, MD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

PREVENTION

Number of Arms

3

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Published Research Related To This Trial

Multidimensional screening and intervention program for neurocognitive disorder in vascular and multimorbid outpatients: Study protocol for a randomized clinical trial.

Cira Fundarò, Nicolò Granata, Silvia Traversoni...

https://pubmed.ncbi.nlm.nih.gov/38985746