Exercise Targeting Cognitive Impairment in Parkinson's Disease

May 30, 2019 updated by: Giselle Petzinger, University of Southern California
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
25

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • United States
    • California
      • Los Angeles, California, United States, 90033-4606
        • University of Southern California

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

30 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
at Baseline, after 12 week intervention, and at 12 week follow up visit
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.
at Baseline, after 12 week intervention
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
at Baseline, after 12 week intervention, and at 12 week follow up visit
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.
at Baseline, after 12 week intervention, and at 12 week follow up visit
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.
at Baseline, after 12 week intervention, and at 12 week follow up visit
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.
at Baseline, after 12 week intervention, and at 12 week follow up visit
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.
at Baseline, after 12 week intervention, and at 12 week follow up visit
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.
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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).
at Baseline, after 12 week intervention, and at 12 week follow up visit
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.
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Body Mass Index
Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Body Fat Percentage
Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Geriatric Anxiety Inventory
Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
at Baseline, after 12 week intervention, and at 12 week follow up visit
Change in Apathy Scale
Time Frame: at Baseline, after 12 week intervention, and at 12 week follow up visit
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit
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
at Baseline, after 12 week intervention, and at 12 week follow up visit

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Southern California

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of California, Los Angeles
National Parkinson Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Giselle M Petzinger, MD, University of Southern California

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2019

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 14, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 14, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 31, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 30, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • HS-14-00422

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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