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The Effect of Exercise on Individuals With Parkinson's Disease

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00591344
Recruitment Status : Completed
First Posted : January 11, 2008
Results First Posted : February 9, 2015
Last Update Posted : March 5, 2015
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Daniel Corcos, Northwestern University

Brief Summary:
The goal of this trial is to compare the effect of two different exercise programs on neuro-physiological, motor, functional, and quality-of-life issues in individuals with Parkinson's disease to determine which program is most beneficial.

Condition or disease Intervention/treatment Phase
Parkinson's Disease Behavioral: Progressive resistance training Behavioral: Modified Fitness Counts Not Applicable

Detailed Description:

Parkinson's disease (PD) negatively affects the quality of life for a million individuals in the United States. While medication and surgery are the most effective treatments for PD, physicians and people with PD often delay using these treatments because of their considerable adverse side effects. Until a cure for PD is discovered, there is a compelling need to develop interventions that provide relief of symptoms without causing negative side effects.

Recent research suggests that exercise may provide symptom relief in some characteristics of PD. While various exercise interventions appear to effectively improve motor, functional, and quality-of-life issues, the research is mixed regarding the nature, extent and duration of these improvements. Understanding how multiple characteristics of PD change and whether they can be modified by different exercise programs is essential to determining if an exercise program is clinically effective for PD.

This study is designed to compare the initial (six months), and then long-term (2 years) effect that 2 different exercise programs (progressive resistance program or flexibility program) have on neuro-physiological, motor, functional, and quality-of-life issues in individuals with Parkinson's disease. The goal is to determine which program is most beneficial. Results from this study will be used to determine which exercise program produces the most beneficial effects on neuro-physiological, motor, functional and quality-of-life measures.

NOTE: Recruitment for Parkinson's disease participants is now closed.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 51 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Exercise on Individuals With Parkinson's Disease
Study Start Date : October 2007
Actual Primary Completion Date : July 2011
Actual Study Completion Date : October 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Progressive resistance training
Subjects will perform between 60 and 90 minutes of progressive resistance training two times a week for two years at a local gym. These sessions will be supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.
Behavioral: Progressive resistance training
Exercise twice a week for 2 years doing either progressive resistance training. The The PRE program consisted of 11 strengthening exercises: chest press, latissimus pull downs, reverse flys, double leg press, hip extension, shoulder press, biceps curl, rotary calf (ankle plantar flexion), triceps extension, seated quadriceps extension and back extension.

Active Comparator: Modified Fitness Counts
Subjects will perform between 60 and 90 minutes of modified Fitness Counts two times a week for two years at a local gym. These sessions will be supervised by a personal trainer two times a week for the first six months of training and then once a week for the remaining 18 months of training.
Behavioral: Modified Fitness Counts
The modified Fitness Counts program was taken from Chapters 2 and 3 of the Parkinson's disease: Fitness Counts booklet and focused on non-progressive stretching, strengthening and balance exercises.




Primary Outcome Measures :
  1. Off Medication UPDRS Part III, Motor Subscale Score [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.


Secondary Outcome Measures :
  1. On Medication UPDRS-III [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    UPDRS part III, is an observer rated clinical measure of motor signs of PD. It is used as a measure of severity of motor signs. We measured this at baseline, 6 , 18 and 24 months. This is a ordinal scale of 0-4 which has 27 items which measures slowness of movement (Bradykinesia), Tremor, Rigidity (muscle stiffness) and postural instabilty. The total value for the UPDRS part III scale which ranges from 0 to 108, with a larger number indicating a higher level of impairment.

  2. L-dopa equivalent-mg/Day [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications.

  3. Elbow Flexion Strength [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is the MVC for elbow flexion

  4. Ankle Plantar Flexion Strength [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is a measure of the MVC for ankle plantar flexion strength

  5. Elbow Extension Strength [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is a measure of the MVC for elbow extension

  6. Ankle Dorsiflexion Strength [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is a measure of the MVC for ankle dorsiflexion

  7. Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is a measure of the percentage of the EMG signal that is contained in different frequency bins during a MVC (elbow flexion/extension; ankle DF/PF), a 50% of MVC elbow fleixon contraction, and a 5 NM elbow flexion contraction.

  8. The Integral of the First Agonist Burst [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    The Integral of the first agonist EMG signal from onset of the agonist EMG signal until peak velocity

  9. Magnitude of the First 30 ms of the Agonist Burst [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    The integral of the first 30 msec of the agonist EMG.

  10. Magnitude of the Antagonist Burst [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    the area under the rectified antagonist signal form agonist EMG onset until the end of movement. This reflects the amount of antagonist activation during movement.

  11. Magnitude of the Agonist Burst [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    Magnitude of the agonist burst reflects the amount of agonist activation during movement.

  12. Duration of First Agonist Burst [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    Time in (ms) for the duration of the first agonist burst during a 72 degree elbow flexion movement and also the percentage of agonist EMG bursts until peak velocity

  13. Number of Agonist Bursts [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is the number of agonist bursts prior to peak velocity.

  14. Co-contraction During Limb Acceleration [ Time Frame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    the amount of agonist and antagonist activity present during limb acceleration.

  15. Qant [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement

  16. Time to Peak Velocity [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    Time of the onset of the movement to peak velocity.

  17. Peak Movement Velocity [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is how fast an individual can perform a 72 degree elbow flexion movement

  18. Relaxation Time [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    Time for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC

  19. Rise Time [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is the time is takes for an individual to go for rest to a 50% of a MVC contraction as fast as possible.

  20. Spatiotemporal Gait Analysis [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    Spatiotemporal gait analysis using a pressure sensitive walk way allow for measurement of gait velocity, step length, single and double limb support time, cadence, ect.

  21. Distance Walked in 6 Minutes [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is how far an individual can walk in 6 minutes

  22. Modified Physical Performance Test [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is an overall measure of physical fuction

  23. Time on the Timed up and go Test [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is the time it takes an individual to get up from a chair, walk 3 meters, turn around and walk back.

  24. Berg Balance Scale Score [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is a overall measure of balance

  25. Functional Reach [ Time Frame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    The distance one can reach forward without taking a step.

  26. Cognitive Function - Stroop Test [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is a test of cognitive function. This test requires individuals to first say as many colors as they can under three different test conditions.

  27. Cognitive Function - Brief Test of Attention [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is a cognitive test of an individuals ability to remember number. It is a test of working memory.

  28. Cognitive Function - Digit Span Forward/Backward [ Time Frame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This tests a persons ability to remember that were read to them both forward and then backwards.

  29. Parkinson 's Disease Quality of Life [ Time Frame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    PDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease.

  30. Epworth Sleepiness Scale [ Time Frame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness.

  31. Beck's Depression Inventory [ Time Frame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    This is a self-report rating inventory that measures characteristic attitudes and symptoms of depression.

  32. 50 ft Walk Time [ Time Frame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    Time it takes to walk 50 feet

  33. 50 Foot Walk Speed [ Time Frame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    The speed that aerson walks over 50 feet

  34. 5 Time Sit to Stand [ Time Frame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period ]
    The time it takes to stand up and sit down five times



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years to 67 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • a diagnosis of PD
  • Up to the age of 67
  • on at least 1 DA drug, may be on several PD medications
  • able to walk for six minutes (may take rest breaks)
  • able to come off their PD medication for testing (12 hour overnight withdrawal of antiparkinsonian medications)
  • able to stay on stable PD medications for at least 6 months
  • live within a 30 mile radius of Chicago
  • Hoehn and Yahr Score: II - III while in the "Off" PD medication state

Exclusion Criteria:

  • history of any other neurological disorder as determined by medical history and neurological exam
  • history of a known injury, disease, or other disorder that might interfere with motor function in the proposed experiments
  • a score less than 23 on the Mini-Mental State Examination
  • currently involved in an active, ongoing formal exercise program deep brain stimulation surgery
  • known cardiac problem or significant hypertension
  • depression that may interfere with regular exercise
  • hallucinations or being treated for hallucinations

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): NCT00591344


Locations
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United States, Illinois
Physical Therapy Department at the University of Illinois at Chicago
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
National Institute of Neurological Disorders and Stroke (NINDS)
Investigators
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Principal Investigator: Daniel Corcos, Ph.D. Northwestern University
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Daniel Corcos, Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT00591344    
Other Study ID Numbers: R01NS028127 ( U.S. NIH Grant/Contract )
5R01NS028127-16 ( U.S. NIH Grant/Contract )
First Posted: January 11, 2008    Key Record Dates
Results First Posted: February 9, 2015
Last Update Posted: March 5, 2015
Last Verified: February 2015
Keywords provided by Daniel Corcos, Northwestern University:
Parkinson's disease
exercise
Additional relevant MeSH terms:
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Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Synucleinopathies
Neurodegenerative Diseases