The Effect of Exercise on Individuals With Parkinson's Disease

Parkinson's Disease Clinical Trial

Official title:

The Effect of Exercise on Individuals With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00591344
• Other study ID #: R01NS028127
• Secondary ID: 5R01NS028127-16
• Status: Completed
• Phase: N/A
• First received: December 26, 2007
• Last updated: February 16, 2015
• Start date: October 2007
• Est. completion date: October 2011

Study information

• Verified date: February 2015
• Source: University of Illinois at Chicago
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: October 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 67 Years

Eligibility

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

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Physical Therapy Department at the University of Illinois at Chicago	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
University of Illinois at Chicago	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No