The Effect of Exercise on Individuals With Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 51
- 试验地点
- 2
- 主要终点
- Off Medication UPDRS Part III, Motor Subscale Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 50 Years 至 67 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Off Medication UPDRS Part III, Motor Subscale Score
时间窗: 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.
次要结局
- Ankle Plantar Flexion Strength(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Ankle Dorsiflexion Strength(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Magnitude of the Antagonist Burst(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Number of Agonist Bursts(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Co-contraction During Limb Acceleration(Obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Berg Balance Scale Score(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Epworth Sleepiness Scale(Obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Beck's Depression Inventory(Obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Time to Peak Velocity(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(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Magnitude of the Agonist Burst(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- L-dopa equivalent-mg/Day(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Elbow Flexion Strength(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Spatiotemporal Gait Analysis(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Time on the Timed up and go Test(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Cognitive Function - Brief Test of Attention(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Parkinson 's Disease Quality of Life(Obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- The Integral of the First Agonist Burst(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- On Medication UPDRS-III(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Rise Time(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Functional Reach(Obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Elbow Extension Strength(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(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Duration of First Agonist Burst(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Cognitive Function - Stroop Test(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Cognitive Function - Digit Span Forward/Backward(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Qant(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Peak Movement Velocity(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Relaxation Time(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Distance Walked in 6 Minutes(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- Modified Physical Performance Test(obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- 50 ft Walk Time(Obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- 50 Foot Walk Speed(Obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
- 5 Time Sit to Stand(Obtained during initial evaluation & then every 6 six months to end of 2-yr training period)
研究者
Daniel Corcos
Professor
Northwestern University