Clinical trial NCT00591344: The Effect of Exercise on Individuals With Parkinson's Disease
Official title: The Effect of Exercise on Individuals With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: Parkinson's disease
exercise
Lead sponsor: University of Illinois at Chicago
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-01-11
Enrollment: 51
Sex: ALL
Minimum age (years): 50
Maximum age (years): 67
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Off Medication UPDRS Part III, Motor Subscale Score
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Secondary outcomes:
measure: On Medication UPDRS-III
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: L-dopa equivalent-mg/Day
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Elbow Flexion Strength
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Ankle Plantar Flexion Strength
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Elbow Extension Strength
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Ankle Dorsiflexion Strength
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: The Integral of the First Agonist Burst
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Magnitude of the First 30 ms of the Agonist Burst
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Magnitude of the Antagonist Burst
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Magnitude of the Agonist Burst
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Duration of First Agonist Burst
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Number of Agonist Bursts
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Co-contraction During Limb Acceleration
timeFrame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Qant
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Time to Peak Velocity
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Peak Movement Velocity
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Relaxation Time
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Rise Time
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Spatiotemporal Gait Analysis
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Distance Walked in 6 Minutes
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Modified Physical Performance Test
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Time on the Timed up and go Test
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Berg Balance Scale Score
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Functional Reach
timeFrame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Cognitive Function - Stroop Test
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Cognitive Function - Brief Test of Attention
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Cognitive Function - Digit Span Forward/Backward
timeFrame: obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Parkinson 's Disease Quality of Life
timeFrame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Epworth Sleepiness Scale
timeFrame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: Beck's Depression Inventory
timeFrame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: 50 ft Walk Time
timeFrame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: 50 Foot Walk Speed
timeFrame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
measure: 5 Time Sit to Stand
timeFrame: Obtained during initial evaluation & then every 6 six months to end of 2-yr training period
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Physical Therapy Department at the University of Illinois at Chicago
state: Illinois
Study officials:
affiliation: Northwestern University
name: Daniel Corcos, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: David FJ, Robichaud JA, Leurgans SE, Poon C, Kohrt WM, Goldman JG, Comella CL, Vaillancourt DE, Corcos DM. Exercise improves cognition in Parkinson's disease: The PRET-PD randomized, clinical trial. Mov Disord. 2015 Oct;30(12):1657-63. doi: 10.1002/mds.26291. Epub 2015 Jul 6.