The Effect of Exercise on Individuals With Parkinson's Disease

Not Applicable

Completed

Conditions: Parkinson's Disease

Interventions: Behavioral: Progressive resistance training
Behavioral: Modified Fitness Counts

Registration Number: NCT00591344

Lead Sponsor: University of Illinois at Chicago

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 51

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Progressive resistance training	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.
Modified Fitness Counts	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.

Primary Outcome Measures

Name	Time	Method
Off Medication UPDRS Part III, Motor Subscale Score	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

Name	Time	Method
Ankle Plantar Flexion Strength	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
Ankle Dorsiflexion Strength	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
Magnitude of the Antagonist Burst	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.
Number of Agonist Bursts	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.
Co-contraction During Limb Acceleration	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.
Berg Balance Scale Score	obtained during initial evaluation & then every 6 six months to end of 2-yr training period	This is a overall measure of balance
Epworth Sleepiness Scale	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.
Beck's Depression Inventory	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.
L-dopa equivalent-mg/Day	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.
Elbow Flexion Strength	obtained during initial evaluation & then every 6 six months to end of 2-yr training period	This is the MVC for elbow flexion
Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions	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.
Magnitude of the Agonist Burst	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.
Time to Peak Velocity	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.
Spatiotemporal Gait Analysis	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.
Time on the Timed up and go Test	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.
Cognitive Function - Brief Test of Attention	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.
Parkinson 's Disease Quality of Life	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.
On Medication UPDRS-III	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.
The Integral of the First Agonist Burst	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
Rise Time	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.
Functional Reach	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.
Elbow Extension Strength	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
Magnitude of the First 30 ms of the Agonist Burst	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.
Duration of First Agonist Burst	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
Cognitive Function - Stroop Test	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.
Cognitive Function - Digit Span Forward/Backward	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.
Qant	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
Peak Movement Velocity	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
Relaxation Time	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
Distance Walked in 6 Minutes	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
Modified Physical Performance Test	obtained during initial evaluation & then every 6 six months to end of 2-yr training period	This is an overall measure of physical fuction
50 ft Walk Time	Obtained during initial evaluation & then every 6 six months to end of 2-yr training period	Time it takes to walk 50 feet
50 Foot Walk Speed	Obtained during initial evaluation & then every 6 six months to end of 2-yr training period	The speed that aerson walks over 50 feet
5 Time Sit to Stand	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