The Effect of Exercise on Individuals With Parkinson's Disease

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Exercise on Individuals With Parkinson's Disease

Conditions
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Parkinson's Disease

Intervention / Treatment
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* Behavioral: Progressive resistance training
* Behavioral: Modified Fitness Counts


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 67 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Progressive resistance training<br>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<br>* 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.<br>|
| Active Comparator: Modified Fitness Counts<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Off Medication UPDRS Part III, Motor Subscale Score | 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. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| On Medication UPDRS-III | 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. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| L-dopa equivalent-mg/Day | This was the equivalent amount of dopamine (mg/day) each subject was prescribed based upon all of their PD medications. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Elbow Flexion Strength | This is the MVC for elbow flexion | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Ankle Plantar Flexion Strength | This is a measure of the MVC for ankle plantar flexion strength | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Elbow Extension Strength | This is a measure of the MVC for elbow extension | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Ankle Dorsiflexion Strength | This is a measure of the MVC for ankle dorsiflexion | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions | 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. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| The Integral of the First Agonist Burst | The Integral of the first agonist EMG signal from onset of the agonist EMG signal until peak velocity | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Magnitude of the First 30 ms of the Agonist Burst | The integral of the first 30 msec of the agonist EMG. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Magnitude of the Antagonist Burst | 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. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Magnitude of the Agonist Burst | Magnitude of the agonist burst reflects the amount of agonist activation during movement. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Duration of First Agonist Burst | 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 | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Number of Agonist Bursts | This is the number of agonist bursts prior to peak velocity. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Co-contraction During Limb Acceleration | the amount of agonist and antagonist activity present during limb acceleration. | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Qant | The integral of the antagonist EMG signal from the onset of the agonist EMG to the end of the movement | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Time to Peak Velocity | Time of the onset of the movement to peak velocity. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Peak Movement Velocity | This is how fast an individual can perform a 72 degree elbow flexion movement | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Relaxation Time | Time for a subject to passively relax their muscle after performing and isometric contraction to 50% of their MVC | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Rise Time | This is the time is takes for an individual to go for rest to a 50% of a MVC contraction as fast as possible. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Spatiotemporal Gait Analysis | 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. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Distance Walked in 6 Minutes | This is how far an individual can walk in 6 minutes | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Modified Physical Performance Test | This is an overall measure of physical fuction | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Time on the Timed up and go Test | This is the time it takes an individual to get up from a chair, walk 3 meters, turn around and walk back. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Berg Balance Scale Score | This is a overall measure of balance | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Functional Reach | The distance one can reach forward without taking a step. | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Cognitive Function - Stroop Test | 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. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Cognitive Function - Brief Test of Attention | This is a cognitive test of an individuals ability to remember number. It is a test of working memory. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Cognitive Function - Digit Span Forward/Backward | This tests a persons ability to remember that were read to them both forward and then backwards. | obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Parkinson 's Disease Quality of Life | PDQ-39 is a composite measure of quality of life in individuals with Parkinson's Disease. | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Epworth Sleepiness Scale | The Epworth Sleepiness Scale is used to determine the level of daytime sleepiness. | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| Beck's Depression Inventory | This is a self-report rating inventory that measures characteristic attitudes and symptoms of depression. | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| 50 ft Walk Time | Time it takes to walk 50 feet | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| 50 Foot Walk Speed | The speed that aerson walks over 50 feet | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 
| 5 Time Sit to Stand | The time it takes to stand up and sit down five times | Obtained during initial evaluation & then every 6 six months to end of 2-yr training period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Parkinson's disease, exercise