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PD-MCIIntensive Physical Therapy Mitigates Cognitive Decline in People With Parkinson's Disease

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Qué se está evaluando

Physical therapy

Otro
Quiénes están siendo reclutados

Sinucleinopatías+6

+ Enfermedades del Sistema Nervioso Central

+ Trastornos Cognitivos

De 50 a 85 años
+7 Criterios de eligibilidad
Ver todos los criterios de elegibilidad
Cómo está diseñado el estudio

Estudio de Tratamiento

Intervencional
Inicio del estudio: septiembre de 2015
Ver detalles del protocolo

Resumen

Patrocinador PrincipalIRCCS National Neurological Institute "C. Mondino" Foundation
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Fecha de inicio: 15 de septiembre de 2015

Fecha en la que se inscribió al primer participante.

Non-pharmacological intervention may represent adjunctive therapy to medications in order to delay the onset of the cognitive deficits or dementia. Previous studies observed a positive effect of cognitive training on cognition both in healthy elderly people and patients in the early stage of neurodegenerative diseases such as PD-MCI. Several exercise interventions have proved to be effective on cognition in PD: tango, aerobic exercises and resistance exercise training. Physical activity may reduce dementia risk has not been established and issues regarding type, frequency and duration of exercises, as well as the best timing in which operate (disease stage and level of cognitive deterioration) remain unresolved. Given the well-established irreversibility of cognitive impairment in neurodegenerative disorders, the scientific attention has shifted more and more on the identification of early interventions that, applied before the onset of deficits, may delay their full development. In this frame, the aim of the present study was to assess the effect of 4-week intensive physical training (6 session/week, 60 minutes/day) on both motor and cognitive impairments in patients with mid-stage PD-MCI. Patients with idiopathic PD and MCI were recruited from the Neurorehabilitation Unit and Parkinson and Movement Disorders Unit of IRCCS Mondino Foundation. All patients were treated with dopamine agonists or L-DOPA and had been on a stable therapy schedule for at least 3 months. No variations were allowed during the training and follow-up period. All groups were sex and age-matched. The PD-MCI diagnosis was formulated on the basis of a comprehensive neuropsychological evaluation (baseline cognitive assessment - T0) according to the guidelines (level II criteria). The following standardized tests assessing different domains were used: * global cognitive function: Mini-Mental State Examination (MMSE) and Montreal Montreal Overall Cognitive Assessment (MoCA); * memory: verbal (Verbal Span, Digit Span) and spatial (Corsi's block-tapping test - CBTT) span; verbal long-term memory (Logical Memory Test immediate and delayed recall) (Rey's 15-word test immediate and delayed recall); spatial long-term memory (Rey Complex Figure delayed recall - RCF-dr); * logical-executive functions: non-verbal reasoning (Raven's Matrices 1947 - RM47) ; categorical abstract reasoning (Weigl's Sorting test); frontal functionality (Frontal Assessment Battery - FAB); semantic fluency (animals, fruits, car brands), phonological fluency (FAS); * attention: visual selective attention (Attentive Matrices) (Carlesimo et al., 1995); simple speed processing and complex attention (Trail Making Test parts A - TMT A and part B - TMT B); * visuospatial abilities: constructive apraxia Rey Complex Figure copy - RCF-copy. At follow-up evaluation, we used a selection of previous tests in order to selectively investigate various features of executive functions. All the test scores were corrected for age, sex, and education and compared with the values available for the Italian population. Motor performances were also assessed by means of MDS-Unified Parkinson's Disease Rating Scale, part III, Tinetti balance and gait score (Tinetti, 1986) and Hauser Index both at the baseline the follow-up evaluation. This study is a prospective controlled, parallel-group randomized study. At baseline (T0) all the PD patients recruited underwent both cognitive and motor assessments. Patients enrolled were randomized to receive physical therapy (PT) or no physical therapy (CT). The physical therapy program consisted of 6 individual sessions/week, each lasting 60 minutes for 4 weeks in addition to their usual pharmacological therapy; while subjects in CT group received only pharmacological therapy. Cognitive and motor performances were evaluated after 4 weeks (T1) by means of the above-mentioned tests to detect the effect of physical therapy on both motor and cognitive performances (T0 vs T1). Our physical therapy program included a variety of different exercise modalities (aerobic exercises, treadmill training and exercise intervention program) performed under the supervision of a physiotherapist, in order to facilitate goal-directed learning through cognitive engagement (learning through verbal feedback, cues, maintaining motivation and attention, improving awareness).

Título OficialIntensive Physical Therapy Mitigates Cognitive Decline in People With Parkinson's Disease
Patrocinador PrincipalIRCCS National Neurological Institute "C. Mondino" Foundation
Última actualización: 27 de enero de 2026
Extraido de una base de datos validada por el gobierno.Reclamar como socio

Protocolo

Esta sección proporciona detalles del plan del estudio, incluyendo cómo está diseñado y qué se está evaluando.
Detalles del Diseño

Se reclutarán 40 pacientes

Número total de participantes que el ensayo clínico espera reclutar.

Estudio de Tratamiento

Estos estudios prueban nuevas formas de tratar una enfermedad, condición o problema de salud. El objetivo es determinar si un nuevo medicamento, terapia o enfoque funciona mejor o tiene menos efectos secundarios que las opciones existentes.



Elegibilidad

Los investigadores buscan pacientes que cumplan ciertos criterios, conocidos como criterios de elegibilidad: estado general de salud o tratamientos previos.
Condiciones
Criterios

Cualquier sexo

Sexo biológico de los participantes elegibles para inscribirse.

De 50 a 85 años

Rango de edades de los participantes que pueden unirse al estudio.

Voluntarios sanos no permitidos

Indica si personas sanas, sin la condición que se estudia, pueden participar.

Condiciones

Patología

SinucleinopatíasEnfermedades del Sistema Nervioso CentralTrastornos CognitivosEnfermedades de los Ganglios BasalesEnfermedades del CerebroTrastornos MentalesTrastornos del MovimientoEnfermedades del sistema nerviosoEnfermedad de Parkinson

Criterios

4 criterios de inclusión requeridos para participar
diagnosis of idiopathic PD according to UKPDBB criteria 26 and Hoehn & Yahr scale ≤3;

presence of PD-MCI single- or multiple-domain;

age between 50 and 85 years;

educational level ≥ 5 years.

3 criterios de exclusión impiden participar
pre-existing cognitive impairment (e.g. aphasia, neglect);

severe disturbances in consciousness;

concomitant severe psychiatric disease or others neurological conditions (e.g. depression and behavioural disorders).

Plan de Estudio

Conoce todos los tratamientos administrados en este estudio, su descripción detallada y en qué consisten.
Grupos de Tratamiento
Objetivos del Estudio

Un solo grupo de intervención está designado en este estudio

0% de probabilidad de ser asignado al grupo placebo

Grupos de Tratamiento

Grupo I

Experimental
The physical therapy program consisted of 6 individual sessions/week, each lasting 60 minutes for 4 weeks in addition to their usual pharmacological therapy

Objetivos del Estudio

Objetivos Primarios

Objetivos Secundarios

Centros del Estudio

Estos son los hospitales, clínicas o centros de investigación donde se lleva a cabo el estudio. Puedes encontrar la ubicación más cercana a ti y su estado de reclutamiento.

Este estudio tiene una ubicación

Suspendido

IRCCS Mondino Foundation

Pavia, ItalyAbrir IRCCS Mondino Foundation en Google Maps
Completado1 Centros de Estudio
PD-MCI | Intensive Physical Therapy Mitigates Cognitive Decline in People With Parkinson's Disease | PatLynk