Physical Therapy and Cognitive Decline (PD-MCI)

July 4, 2019 updated by: IRCCS National Neurological Institute "C. Mondino" Foundation

Intensive Physical Therapy Mitigates Cognitive Decline in People With Parkinson's Disease

Background: Mild Cognitive Impairment in Parkinson's disease (PD-MCI) is considered a predictor for the development of dementia, a major source of eventual treatment-refractory disability. Physical activity, which has proved effective in improving motor symptom, has also been proposed as a possible non-pharmacological intervention for preventing/delaying the onset of cognitive impairment in Parkinson's disease (PD).

Objectives: This study evaluates the effect of a 4-week rehabilitation therapy on cognitive functions in mid-stage PD-MCI patients.

Methods: 40 PD-MCI patients were randomized to receive physical therapy (PT) or no physical therapy (CT) according to a controlled single-blind design. Subjects in the PT group (n. 17) attended a rehabilitation program with 6 sessions/week, each lasting 60 minutes, for 4 weeks in addition to their usual pharmacological therapy; subjects in CT group (n. 22) received only pharmacological therapy. Cognitive and motor functions were assessed at baseline (T0) and at the end of the intervention period (T1) in both groups.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Pavia, Italy, 27100
        • IRCCS Mondino Foundation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: physical therapy (PT)
The physical therapy program consisted of 6 individual sessions/week, each lasting 60 minutes for 4 weeks in addition to their usual pharmacological therapy
Other: Physical therapy
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
NO_INTERVENTION: No physical therapy (CT)
Subjects in CT group received only standard medication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
global cognitive functioning
Time Frame: after 4-week rehabilitative program
Measured by Montreal Overall Cognitive Assessment (MoCA). We considered as a clinical significant improvement an increase of 3 points in MoCA. Range scale 0-30. Higher values indicate a better outcome.
after 4-week rehabilitative program

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Motor performances
Time Frame: after 4-week rehabilitative program

Motor performances were assessed by MDS-Unified Parkinson's Disease Rating Scale, part III. This portion of this scale assesses the motor signs of Parkinson Disease.

The scale has 18 subitems and each items have an integer rating (score 0-4, where 0 is the best performance and 4 is the worst outcome)
after 4-week rehabilitative program

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

IRCCS National Neurological Institute "C. Mondino" Foundation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 15, 2015

Primary Completion (ACTUAL)

December 15, 2017

Study Completion (ACTUAL)

March 15, 2018

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

July 4, 2019

First Posted (ACTUAL)

July 9, 2019

Study Record Updates

Last Update Posted (ACTUAL)

July 9, 2019

Last Update Submitted That Met QC Criteria

July 4, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PD-MCI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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