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Completed

NCT Number: NCT00591344

The Effect of Exercise on Individuals With Parkinson's Disease

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.

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Key information

Age range

50 year–67 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Physical Therapy Department at the University of Illinois at Chicago

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Progressive resistance training

Behavioral

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.

Modified Fitness Counts

Behavioral

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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Important dates

Study start
2007
Primary completion
2011
Study completion
2011
First posted
Jan 11, 2008
Registry last updated
Mar 5, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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