search
Back to results

Physical Therapy and Cognitive Decline (PD-MCI)

Primary Purpose

Parkinson Disease, Cognitive Impairment

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Physical therapy
Sponsored by
IRCCS National Neurological Institute "C. Mondino" Foundation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Parkinson Disease focused on measuring Cognitive decline, Physical therapy, Parkinson's Disease

Eligibility Criteria

50 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • IRCCS Mondino Foundation

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

physical therapy (PT)

No physical therapy (CT)

Arm Description

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

Subjects in CT group received only standard medication.

Outcomes

Primary Outcome Measures

global cognitive functioning
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.

Secondary Outcome Measures

Motor performances
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)

Full Information

First Posted
June 27, 2019
Last Updated
July 4, 2019
Sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT04012086
Brief Title
Physical Therapy and Cognitive Decline
Acronym
PD-MCI
Official Title
Intensive Physical Therapy Mitigates Cognitive Decline in People With Parkinson's Disease
Study Type
Interventional

2. Study Status

Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
September 15, 2015 (Actual)
Primary Completion Date
December 15, 2017 (Actual)
Study Completion Date
March 15, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IRCCS National Neurological Institute "C. Mondino" Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease, Cognitive Impairment
Keywords
Cognitive decline, Physical therapy, Parkinson's Disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective controlled, parallel-group randomized study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
physical therapy (PT)
Arm Type
Experimental
Arm Description
The physical therapy program consisted of 6 individual sessions/week, each lasting 60 minutes for 4 weeks in addition to their usual pharmacological therapy
Arm Title
No physical therapy (CT)
Arm Type
No Intervention
Arm Description
Subjects in CT group received only standard medication.
Intervention Type
Other
Intervention Name(s)
Physical therapy
Intervention Description
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
Primary Outcome Measure Information:
Title
global cognitive functioning
Description
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.
Time Frame
after 4-week rehabilitative program
Secondary Outcome Measure Information:
Title
Motor performances
Description
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)
Time Frame
after 4-week rehabilitative program

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristina Tassorelli, Prof
Organizational Affiliation
IRCCS Mondino Foundation, Pavia
Official's Role
Study Director
Facility Information:
Facility Name
IRCCS Mondino Foundation
City
Pavia
ZIP/Postal Code
27100
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
22275317
Citation
Litvan I, Goldman JG, Troster AI, Schmand BA, Weintraub D, Petersen RC, Mollenhauer B, Adler CH, Marder K, Williams-Gray CH, Aarsland D, Kulisevsky J, Rodriguez-Oroz MC, Burn DJ, Barker RA, Emre M. Diagnostic criteria for mild cognitive impairment in Parkinson's disease: Movement Disorder Society Task Force guidelines. Mov Disord. 2012 Mar;27(3):349-56. doi: 10.1002/mds.24893. Epub 2012 Jan 24.
Results Reference
background
PubMed Identifier
28735855
Citation
Livingston G, Sommerlad A, Orgeta V, Costafreda SG, Huntley J, Ames D, Ballard C, Banerjee S, Burns A, Cohen-Mansfield J, Cooper C, Fox N, Gitlin LN, Howard R, Kales HC, Larson EB, Ritchie K, Rockwood K, Sampson EL, Samus Q, Schneider LS, Selbaek G, Teri L, Mukadam N. Dementia prevention, intervention, and care. Lancet. 2017 Dec 16;390(10113):2673-2734. doi: 10.1016/S0140-6736(17)31363-6. Epub 2017 Jul 20. No abstract available.
Results Reference
background
PubMed Identifier
30619031
Citation
Zucchella C, Sinforiani E, Tamburin S, Federico A, Mantovani E, Bernini S, Casale R, Bartolo M. The Multidisciplinary Approach to Alzheimer's Disease and Dementia. A Narrative Review of Non-Pharmacological Treatment. Front Neurol. 2018 Dec 13;9:1058. doi: 10.3389/fneur.2018.01058. eCollection 2018.
Results Reference
background
PubMed Identifier
26715466
Citation
Reynolds GO, Otto MW, Ellis TD, Cronin-Golomb A. The Therapeutic Potential of Exercise to Improve Mood, Cognition, and Sleep in Parkinson's Disease. Mov Disord. 2016 Jan;31(1):23-38. doi: 10.1002/mds.26484. Epub 2015 Dec 30.
Results Reference
background
PubMed Identifier
29198450
Citation
Amara AW, Memon AA. Effects of Exercise on Non-motor Symptoms in Parkinson's Disease. Clin Ther. 2018 Jan;40(1):8-15. doi: 10.1016/j.clinthera.2017.11.004. Epub 2017 Dec 1.
Results Reference
background
PubMed Identifier
24559472
Citation
Murray DK, Sacheli MA, Eng JJ, Stoessl AJ. The effects of exercise on cognition in Parkinson's disease: a systematic review. Transl Neurodegener. 2014 Feb 24;3(1):5. doi: 10.1186/2047-9158-3-5.
Results Reference
background
PubMed Identifier
23769598
Citation
Petzinger GM, Fisher BE, McEwen S, Beeler JA, Walsh JP, Jakowec MW. Exercise-enhanced neuroplasticity targeting motor and cognitive circuitry in Parkinson's disease. Lancet Neurol. 2013 Jul;12(7):716-26. doi: 10.1016/S1474-4422(13)70123-6.
Results Reference
background
PubMed Identifier
27027891
Citation
Picelli A, Varalta V, Melotti C, Zatezalo V, Fonte C, Amato S, Saltuari L, Santamato A, Fiore P, Smania N. Effects of treadmill training on cognitive and motor features of patients with mild to moderate Parkinson's disease: a pilot, single-blind, randomized controlled trial. Funct Neurol. 2016 Jan-Mar;31(1):25-31. doi: 10.11138/fneur/2016.31.1.025.
Results Reference
background
PubMed Identifier
19006643
Citation
Tanaka K, Quadros AC Jr, Santos RF, Stella F, Gobbi LT, Gobbi S. Benefits of physical exercise on executive functions in older people with Parkinson's disease. Brain Cogn. 2009 Mar;69(2):435-41. doi: 10.1016/j.bandc.2008.09.008. Epub 2008 Nov 8.
Results Reference
background
PubMed Identifier
8954307
Citation
Carlesimo GA, Caltagirone C, Gainotti G. The Mental Deterioration Battery: normative data, diagnostic reliability and qualitative analyses of cognitive impairment. The Group for the Standardization of the Mental Deterioration Battery. Eur Neurol. 1996;36(6):378-84. doi: 10.1159/000117297.
Results Reference
background
PubMed Identifier
20199518
Citation
Cruise KE, Bucks RS, Loftus AM, Newton RU, Pegoraro R, Thomas MG. Exercise and Parkinson's: benefits for cognition and quality of life. Acta Neurol Scand. 2011 Jan;123(1):13-9. doi: 10.1111/j.1600-0404.2010.01338.x.
Results Reference
background
PubMed Identifier
26148003
Citation
David FJ, Robichaud JA, Leurgans SE, Poon C, Kohrt WM, Goldman JG, Comella CL, Vaillancourt DE, Corcos DM. Exercise improves cognition in Parkinson's disease: The PRET-PD randomized, clinical trial. Mov Disord. 2015 Oct;30(12):1657-63. doi: 10.1002/mds.26291. Epub 2015 Jul 6.
Results Reference
background
PubMed Identifier
33978924
Citation
Avenali M, Picascia M, Tassorelli C, Sinforiani E, Bernini S. Evaluation of the efficacy of physical therapy on cognitive decline at 6-month follow-up in Parkinson disease patients with mild cognitive impairment: a randomized controlled trial. Aging Clin Exp Res. 2021 Dec;33(12):3275-3284. doi: 10.1007/s40520-021-01865-4. Epub 2021 May 12.
Results Reference
derived

Learn more about this trial

Physical Therapy and Cognitive Decline

We'll reach out to this number within 24 hrs