N/A
Completed N=51
The Effect of Exercise on Individuals With Parkinson's Disease
Source: ClinicalTrials.gov NCT00591344 ↗Enrolled (actual)
51
Serious AEs
27.5%
Results posted
Feb 2015
Primary outcomePrimary: Off Medication UPDRS Part III, Motor Subscale Score — 34.7; 34.5; 29.3; 28.0 units on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Off Medication UPDRS Part III, Motor Subscale Score |
34.7; 34.5; 29.3; 28.0; 32.8; 28.4 | — |
| SECONDARY On Medication UPDRS-III |
20.9; 21.6; 17.7; 19.1; 19.1; 19.4 | — |
| SECONDARY L-dopa equivalent-mg/Day |
704.5; 597.8; 741.2; 619.0; 772.2; 638.1 | — |
| SECONDARY Elbow Flexion Strength |
— | — |
| SECONDARY Ankle Plantar Flexion Strength |
— | — |
| SECONDARY Elbow Extension Strength |
— | — |
| SECONDARY Ankle Dorsiflexion Strength |
— | — |
| SECONDARY Percentage of Agonist EMG Signal Contained in the 0-5, 5-15, 15-30, and 35-50 Hz Frequency Bins During Isometric Contractions |
— | — |
| SECONDARY The Integral of the First Agonist Burst |
— | — |
| SECONDARY Magnitude of the First 30 ms of the Agonist Burst |
— | — |
| SECONDARY Magnitude of the Antagonist Burst |
— | — |
| SECONDARY Magnitude of the Agonist Burst |
— | — |
| SECONDARY Duration of First Agonist Burst |
— | — |
| SECONDARY Number of Agonist Bursts |
— | — |
| SECONDARY Co-contraction During Limb Acceleration |
— | — |
| SECONDARY Qant |
— | — |
| SECONDARY Time to Peak Velocity |
— | — |
| SECONDARY Peak Movement Velocity |
— | — |
| SECONDARY Relaxation Time |
— | — |
| SECONDARY Rise Time |
— | — |
| SECONDARY Spatiotemporal Gait Analysis |
— | — |
| SECONDARY Distance Walked in 6 Minutes |
— | — |
| SECONDARY Modified Physical Performance Test |
— | — |
| SECONDARY Time on the Timed up and go Test |
— | — |
| SECONDARY Berg Balance Scale Score |
— | — |
| SECONDARY Functional Reach |
— | — |
| SECONDARY Cognitive Function - Stroop Test |
— | — |
| SECONDARY Cognitive Function - Brief Test of Attention |
— | — |
| SECONDARY Cognitive Function - Digit Span Forward/Backward |
— | — |
| SECONDARY Parkinson 's Disease Quality of Life |
— | — |
| SECONDARY Epworth Sleepiness Scale |
— | — |
| SECONDARY Beck's Depression Inventory |
— | — |
| SECONDARY 50 ft Walk Time |
— | — |
| SECONDARY 50 Foot Walk Speed |
— | — |
| SECONDARY 5 Time Sit to Stand |
— | — |
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
Data sourced from ClinicalTrials.gov (NCT00591344). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.