Physical Therapy and Cognitive Decline

Parkinson Disease Clinical Trial

— PD-MCI  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04012086
• Other study ID #: PD-MCI
• Status: Completed
• Phase: N/A
• Start date: September 15, 2015
• Est. completion date: March 15, 2018

Study information

• Verified date: July 2019
• Source: IRCCS National Neurological Institute "C. Mondino" Foundation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 15, 2018
• Est. primary completion date: December 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years to 85 Years

Eligibility

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).

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Cognitive Impairment
• Parkinson Disease

Intervention

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

Locations

Country	Name	City	State
Italy	IRCCS Mondino Foundation	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
IRCCS National Neurological Institute "C. Mondino" Foundation

Country where clinical trial is conducted

Italy, 

References & Publications (12)

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. — View 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. — View 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. — View 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. — View Citation

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. — View 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, 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. — View 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. — View 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. — View 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. — View 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. Review. — View 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. — View 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. Review. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	after 4-week rehabilitative program
Secondary	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)	after 4-week rehabilitative program