Exploratory Study of Different Doses of Endurance Exercise in People With Parkinson Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 128
- 试验地点
- 6
- 主要终点
- Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise
研究概览
简要总结
The purpose of this study is to learn more about the effects of exercise on patients who have been recently diagnosed with Parkinson's disease (PD). The investigators are going to test two levels of exercise (moderate to vigorous) against no exercise. The investigators think that exercise may reduce the symptoms the of PD, and the investigators hope to learn what level of exercise will offer the most benefit.
详细描述
The overall objective of this study is to determine the futility or non-futility of conducting a randomized controlled trial to determine the effects of exercise on the progression of PD symptoms. The primary aim is to determine whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% HRmax or 80-85% HRmax) and adhere to the exercise protocol.
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
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of primary Parkinson's disease
- •In a Hoehn and Yahr stage less than stage III
- •Disease duration is less than 5 years
- •Not likely to require dopaminergic therapy within 6 months
排除标准
- •Use of any PD medication within 60 days prior to the beginning the study, including levodopa, direct dopamine agonists, amantadine, Rasagiline (Azilect), Selegiline (Eldepryl), Artane (trihexyphenidyl).
- •Duration of previous use of medications for PD that exceeds 90 days
- •Expected to require dopaminergic therapy in the next 6 months
- •Poorly controlled or unstable cardiovascular disease
- •Uncontrolled hypertension
- •Hypo- or hyperthyroidism, abnormal liver function, abnormal renal function
- •Mild cognitive impairment (Montreal Cognitive Assessment score<26/30)
- •Depression that precludes ability to exercise (Beck depression score>13)
- •Disorders that interfere with ability to perform endurance exercises
- •Regular participation in vigorous endurance exercise
- •Evidence of serious arrhythmias or ischemic heart disease
- •Any clinically significant medical condition, psychiatric condition, drug or alcohol abuse, or laboratory abnormality that would, in the judgment of the investigators, interfere with the ability to participate in the study
研究组 & 干预措施
Vigorous Exercise
Endurance exercise at 80-85% HR max, 4x/wk for 6 months.
干预措施: Vigorous Exercise (Behavioral)
Moderate Exercise
Endurance exercise at 60-65% HR max, 4x/wk for 6 months.
干预措施: Moderate Exercise (Behavioral)
Control Group
Wait listed to moderate or vigorous exercise after 6 months of no exercise.
干预措施: No Intervention (Behavioral)
结局指标
主要结局
Percentage of Average Maximum Heart Rate During Exercise as a Measure of Adherence to Exercise
时间窗: 9 to 26 weeks
To test whether individuals with de novo Parkinson's disease (naïve to drug treatment) can achieve the randomly assigned levels of mean exercise intensity (60-65% average HRmax or 80-85% average HRmax) and adhere to the exercise protocol.
次要结局
- 6 Month Change in Unified Parkinson's Disease Rating Scale (UPDRS) Motor Score(Baseline and 6 months)