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Exercise Targeting Cognitive Impairment in Parkinson's Disease

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ClinicalTrials.gov Identifier: NCT02267785
Recruitment Status : Unknown
Verified May 2019 by Giselle Petzinger, University of Southern California.
Recruitment status was:  Active, not recruiting
First Posted : October 17, 2014
Last Update Posted : May 31, 2019
Sponsor:
Collaborators:
National Parkinson Foundation
University of California, Los Angeles
Information provided by (Responsible Party):
Giselle Petzinger, University of Southern California

Study Description
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Brief Summary:
The aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on mild cognitive impairment (MCI) of the executive function (EF) subtype in Parkinson's disease (PD); we hypothesize that skill-based exercise will result in the greatest improvement in EF and lead to modification of underlying neural substrates.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Other: Skill-Based Exercise Other: Aerobic Exercise Other: Social Contact Not Applicable

Detailed Description:
Mild cognitive impairment (MCI), particularly of the executive function (EF) subtype, is common in Parkinson's disease (PD) and transitions to dementia, increased fall risk, and poor quality of life. EF is a set of processes that include mental flexibility and attention that are needed to learn and optimize performance of complex cognitive and motor skills. Such skills include the ability to generalize task performance under different conditions (context processing) and to perform two tasks simultaneously termed dual-task (DT) performance. Deficits in EF lead to problems in daily functioning and loss of independence and create psychosocial and economic burdens on patients and caregivers and stakeholders including health care providers. There is currently no effective treatment in PD to address EF deficits. Our animal and clinical studies in PD demonstrate that skilled exercise facilitates neuroplasticity of the basal ganglia (BG), a brain region sub-serving EF and supports the hypothesis that exercise will reverse EF deficits in PD. Furthermore, recent studies in healthy aging support that skill-based exercise that specifically promotes motor skill fitness (MSF), compared with aerobic exercise that promotes cardiovascular fitness (CF), has a greater impact on EF and related BG circuits. The aim of this application is to compare and elucidate the effects of skill-based versus aerobic exercise versus control on MCI of the EF subtype in PD; we hypothesize that skill-based exercise will result in the greatest improvement in EF and lead to modification of underlying neural substrates.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Exercise Targeting Cognitive Impairment in Parkinson's Disease
Study Start Date : October 2014
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Skill-Based Exercise
Participants assigned to this arm will complete the Skill-Based Exercise Intervention
 Other: Skill-Based Exercise
The skill-based exercise program is designed to improve skilled function, fine and gross- motor body coordination. The intervention will be focused on acquisition and improvement of complex movements for the whole body and include the following general categories of activities: (1) balance, (2) eye-hand coordination, (3) leg-arm coordination; 4) reaction time to moving objects/persons; (5) dynamic gait and 6) functional activity performance. The treating therapist will direct both general principles of progression and progression specific to each category.
Experimental: Aerobic Exercise
Participants assigned to this arm will complete the Aerobic Exercise Intervention
 Other: Aerobic Exercise
The aerobic cardiovascular exercise will consist of 36 1-hour sessions performed 3 times weekly over 12 weeks. Aerobic exercise will consist of cycling on a recumbent stationary bicycle. Each session will begin and end with gentle stretching. Continuous cycling will be performed for 45-50 minutes, with the first and last 5 minutes designated as warm-up and cool-down periods. The intensity of the middle 30 minutes of cycling will be increased progressively from an initial target of 50% maximum heart rate (HR) during week 1 to 75% of maximum HR by week 12. The initial intensity will be set at 50% of maximum HR. Participants will be encouraged to cycle as fast as they can, with a goal of maintaining 90 revolutions per minute (RPM) throughout the middle 30-minute period. Pedaling resistance will be kept low throughout all sessions. Measures of heart rate via heart rate monitors, blood pressure, RPM, and rate of perceived exertion will be recorded at 5-minute intervals.
Experimental: Social Contact Group
Participants assigned to this arm will complete the Social Contact Intervention
 Other: Social Contact
The control Social Contact group will consist of an equal amount of social contact as the exercise group. Subjects will have weekly visits at the University of Southern California with the study coordinator. The goal is for 3 hours of social contact every week for a total of 36 hours over 12 weeks. Activities scheduled for the social contact visits will include: (1) support group interactions and (2) social outings such as a trip to a museum, local café for lunch or dinner; (3) book club; (4) sports event. Support group interaction can include discussions among patients and caregivers, presentations from experts in various aspects of PD. They will be instructed to continue with their usual level of activity but refrain from beginning new exercise activities during the study period.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Context Dependent Motor Learning (CDML) [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    All subjects from each group will undergo a finger sequence motor learning task to determine exercise effects on EF as evaluated through improvement in the transfer of a learned motor task from one contextual setting to another.

  2. Change in Dual Task Performance and Functional Magnetic Resonance Imaging (fMRI) [ Time Frame: at Baseline, after 12 week intervention ]
    A subset of subjects (60 representing 20 per group) will be invited to undergo fMRI studies at University of California, Los Angeles. Patients will perform a learned single finger-sequencing task (a condition of the CDML) with an additional secondary dual task (DT) component during an fMRI scan.

  3. Change in D-KEFS Verbal Fluency Test [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The D-KEFS Verbal Fluency test will be used to evaluate executive function

  4. Change in Tower of London Test [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The Tower of London test will be used to evaluate executive function

  5. Change in Wisconsin Card Sorting Test [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The Wisconsin Card Sorting test will be used to evaluate executive function


Secondary Outcome Measures :
  1. Change in Parkinson Disease Questionnaire-39 (PDQ-39) [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    Parkinson Disease Questionnaire-39 (PDQ-39) will be used to indicate overall quality of life and frequency with which patients experience difficulties; high scores for the PDQ-39 reflect poorer quality of life.

  2. Change in Evaluation of PD Motor Symptoms with Movement Disorder Society Unified Parkinson's Disease Rating Scale (MDS-UPDRS) [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The MDS-UPDRS is the established gold standard that is currently used for the vast majority of clinical settings and for scientific trials. This scale was developed in 1987 and is the most widely used tool in PD.

  3. Change in Activity Specific Balance Confidence (ABC) Scale [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    Activity Specific Balance Confidence (ABC) Scale is a 16-item self-report in which patients rate their balance confidence in performing several activities; high scores indicate greater balance confidence.

  4. Change in Confidence in ability to maintain an exercise program (CONF) [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The CONF scale includes nine items, which assesses how sure subjects are that they would do exercise under different conditions or constraints, including when they are tired.

  5. Change in Exercise Control Beliefs (BEL) [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The BEL, 6-item scale was developed to assess beliefs about control over exercise behavior.

  6. Change in Self-efficacy for Exercise Scale (EFFIC) [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The EFFIC scale is a self-efficacy barriers to exercise measure, a 13-item instrument that focuses on self-efficacy expectations related to the ability to continue exercising in the face of barriers to exercise.

  7. Change in Frontal Systems Behavior Scale (FrSBe) [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The FrSBe assesses changes in behavior dysfunction and disturbances associated with frontal-subcortical damage, which is the circuitry involved with executive functioning

  8. Change in Motor Skill Fitness [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    An individual's Motor skill fitness will be a composite score of their Physical Performance Test (PPT) and their Timed Up and Go (TUG).

  9. Change in Cardiovascular Fitness [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    Subjects will participate in testing designed to determine their level of cardiovascular fitness by estimating maximal oxygen uptake (V02max) known as the Balke treadmill submaximal fitness test and has been optimized for use in samples of elderly adults.

  10. Change in Lifetime Total Physical Activity Questionnaire (LTPAQ) [ Time Frame: at Baseline ]
    The LPAQ measures the time spent in physical activity over the lifetime of the subject

  11. Change in Global Physical Activity Questionnaire (GPAQ) [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The GPAQ measures the time spent in physical activity during a normal week

  12. Change in Body Mass Index [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
  13. Change in Body Fat Percentage [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
  14. Change in Mattis Dementia Rating Scale [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The Mattis Dementia Rating Scale will be used to differentiate between study subjects with mild cognitive impairment and dementia

  15. Change in Geriatric Depression Scale [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The Geriatric Depression Scale will be used to evaluate study subjects for depression

  16. Change in Geriatric Anxiety Inventory [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
  17. Change in Apathy Scale [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
  18. Change in Revised Activities of Daily Living Scale [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The Revised Activities of Daily Living Scale will be used to evaluate independent living skills

  19. Change in the Frontal Systems Behavior Scale (FrSBe) [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The FrSBe will be used to evaluate frontal systems behavior

  20. Change in Adaptive Digit Ordering Test [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The Adaptive Digit Ordering Test will be used to evaluate attention and working memory

  21. Change in Hooper Visual Organization Test [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The Hooper Visual Organization Test will be used to evaluate visuospatial function

  22. Change in Benton's Judgment of Line Orientation [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The Benton's Judgment of Line Orientation test will be used to evaluate visuospatial function

  23. Change in D-KEFS Color Word Interference Test [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The D-KEFS Color Word Interference Test will be used to evaluate attention, working memory and executive function

  24. Change in California Verbal Learning Test- 2nd Edition (CVLT-II) [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The CVLT-II will be used to evaluate memory function

  25. Change in WMS-II Visual Reproduction Test [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The WMS-II Visual Reproduction Test will be used to evaluate memory function

  26. Change in WAIS-IV Similarities Test [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The WAIS-IV Similarities test will be used to evaluate language function

  27. Change in Boston Naming Test [ Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit ]
    The Boston Naming Test will be used to evaluate language function


Eligibility Criteria
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Ages Eligible for Study:   30 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • willing and able to provide informed consent
  • confirmed diagnosis of idiopathic PD based on the United Kingdom Brain Bank criteria
  • Mild cognitive impairment (Level II criteria Movement Disorder Task Force)
  • medically eligible for MRI imaging
  • able to provide a written medical clearance from their primary physician to participate in exercise
  • stable PD medications for 3 months

Exclusion Criteria:

  • a Hoehn & Yahr staging greater than 2.5 at screening
  • severe cardiac disease (New York Heart Association classification IIIV)
  • history of an abnormal stress test
  • clinically significant medical or psychiatric illness
  • electrically, magnetically, or mechanically activated implant (such as cardiac pacemakers or intracerebral vascular clip)
  • metal in any part of the body including metal injury to the eye
  • past history of brain lesions (such as stroke)
  • seizures or unexplained spells of loss of consciousness
  • family history of epilepsy
  • physical therapy within 6 months of the study
  • symptomatic orthostatic hypotension at the screening visit
  • orthopedic and other movement-influencing diseases such as arthritis or total hip joint replacement
  • requirement for central nervous system active therapies (e.g. hypnotics, antidepressants, anxiolytics)
  • moderate or severe depression or apathy using the Geriatric depression scale and Apathy scale
  • taking anticholinesterase inhibitors
  • taking anticholinergic medication
  • PD dementia
  • Colorblindness
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02267785


Locations
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United States, California
University of Southern California
Los Angeles, California, United States, 90033-4606
Sponsors and Collaborators
University of Southern California
National Parkinson Foundation
University of California, Los Angeles
Investigators
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Principal Investigator: Giselle M Petzinger, MD University of Southern California
More Information
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Responsible Party: Giselle Petzinger, Assistant Professor of Neurology, University of Southern California
ClinicalTrials.gov Identifier: NCT02267785    
Other Study ID Numbers: HS-14-00422
First Posted: October 17, 2014    Key Record Dates
Last Update Posted: May 31, 2019
Last Verified: May 2019
Keywords provided by Giselle Petzinger, University of Southern California:
exercise
mild cognitive impairment
Parkinson's Disease
Additional relevant MeSH terms:
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Parkinson Disease
Cognitive Dysfunction
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Movement Disorders
Synucleinopathies
Neurodegenerative Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders