Sensory Attention Focused Exercise in Parkinson's Disease: A Randomized Double-Crossover Trial.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score)
研究概览
简要总结
The purpose of this study is 1.) to determine if sensory attention focused exercise is an effective management strategy for Parkinson's disease, and 2.) to identify if the benefits are a result of strength gains.
详细描述
Currently, there is no cure for Parkinson's disease (PD) and although medication offers symptom reduction, there are many negative side effects associated with medication use. Thus, there has been an increased emphasis on exercise interventions for symptom reduction. Recent research has shown that both sensory attention focused exercise (SAFEx) and strength training interventions improved disease severity more so than other exercise interventions (such as aerobic, aquatic and no exercise). Upon closer examination, SAFEx showed further symptom improvements than the strength training program. Thus exists the need to further examine SAFEx using a standardized protocol - a single-blind randomized double-crossover trial - that has been used sparingly in exercise interventions. In addition, the 30-second chair stand has been implemented into the testing protocol, as it has been shown to be a reliable measurement of functional strength for older adults. This test was implemented in order to identify the functional strength gains, if any, that are associated with SAFEx. It is hypothesized that the SAFEx intervention will improve disease symptoms in PD, and that the results will not be due to strength gains.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •diagnosis of PD by a clinician/neurologist
- •absence of mentation
- •established medication schedule and dosage
排除标准
- •mentation
- •change in medication during period of study
- •change in exercise level during period of study
- •inability to complete the exercise program
- •absence of 5 or more classes, or absence of 3 or more classes in sequence
结局指标
主要结局
Unified Parkinson's Disease Rating Scale (UPDRS) III (motor score)
时间窗: Baseline, 12 weeks and 24 weeks
Assessment of patient's disease severity, completed by a blinded certified clinician.
次要结局
- Timed up and go(Baseline, 12 weeks and 24 weeks)
- 30 second chair stand(Baseline, 12 weeks and 24 weeks)
- Unified Parkinson's Disease Rating Scale (UPDRS) - I and II (self report of mentation, depression, and activities of daily living).(Baseline, 12 weeks and 24 weeks)
- Grooved Pegboard(Baseline, 12 weeks and 24 weeks)
- Step Length(Baseline, 12 weeks and 24 weeks)
- Velocity(Baseline, 12 weeks and 24 weeks)
- Step to Step Length Variability(Baseline, 12 weeks and 24 weeks)