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出境医 / 临床实验 / Physical Therapy and Cognitive Decline (PD-MCI)

Physical Therapy and Cognitive Decline (PD-MCI)

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.


Condition or disease Intervention/treatment Phase
Parkinson Disease Cognitive Impairment Other: Physical therapy Not Applicable

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Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective controlled, parallel-group randomized study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Intensive Physical Therapy Mitigates Cognitive Decline in People With Parkinson's Disease
Actual Study Start Date : September 15, 2015
Actual Primary Completion Date : December 15, 2017
Actual Study Completion Date : March 15, 2018
Arms and Interventions
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.
Outcome Measures
Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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)



Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   50 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Contacts and Locations

Locations
Layout table for location information
Italy
IRCCS Mondino Foundation
Pavia, Italy, 27100
Sponsors and Collaborators
IRCCS National Neurological Institute "C. Mondino" Foundation
Investigators
Layout table for investigator information
Study Director: Cristina Tassorelli, Prof IRCCS Mondino Foundation, Pavia
Tracking Information
First Submitted Date  ICMJE June 27, 2019
First Posted Date  ICMJE July 9, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE September 15, 2015
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019) 		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.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019) 		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)
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Physical Therapy and Cognitive Decline
Official Title  ICMJE Intensive Physical Therapy Mitigates Cognitive Decline in People With Parkinson's Disease
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Prospective controlled, parallel-group randomized study
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Parkinson Disease
  • Cognitive Impairment
Intervention  ICMJE 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
Study Arms  ICMJE
  • 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
    Intervention: Other: Physical therapy
  • No Intervention: No physical therapy (CT)
    Subjects in CT group received only standard medication.
Publications *
  • Litvan I, Goldman JG, Tröster 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. Review.
  • 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, Selbæk 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. Review.
  • 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. Review.
  • 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. Review.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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 May 12. doi: 10.1007/s40520-021-01865-4. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2019) 		40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE March 15, 2018
Actual Primary Completion Date December 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 50 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04012086
Other Study ID Numbers  ICMJE PD-MCI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party IRCCS National Neurological Institute "C. Mondino" Foundation
Study Sponsor  ICMJE IRCCS National Neurological Institute "C. Mondino" Foundation
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Cristina Tassorelli, Prof IRCCS Mondino Foundation, Pavia
PRS Account IRCCS National Neurological Institute "C. Mondino" Foundation
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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