Effects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- The Influence of Hyperthermic Baths on Motor Symptoms as Assessed by the Modified Webster Symptoms Score
研究概览
简要总结
The aim of this study is to further evaluate the effects of seasonal variation and the aquatic thermal environment of hyperthermic baths (HTB) on the Motor Symptoms (MS) of Parkinson's Disease (PD), and whether the environmental temperature is associated with these effects.
详细描述
After being informed about the study and potential risks, all participants will give written informed consent. All participants who meet the inclusion criteria will undergo a complete history and physical examination, including an assessment using the Movement Disorder Society-United Parkinson's Disease Rating Scale (MDS-UPDRS), H&Y stage, MMSE and MOCA. Each participant will receive two subjective measures (the Movement Disorder Society-United Parkinson's Disease Rating Scale part III motor examination total scores and the modified Webster Symptoms Score) nine times in an open medication state (open state). Each participant will take hyperthermic baths (HTB) at the same time on the first, third and fifth days. The participants will receive subjective measures before and after the HTB. The time at which the subjective measures begin after the HTB will be recorded. In the second week, no participants accept any intervention. To avoid the effects of fluctuations in dopaminergic drugs concentrations, subjective measures will be given without HTB at the recorded times on the fifteenth, seventeenth and nineteenth days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •≥ 18 years of age
- •Diagnosis of Idiopathic Parkinson's Disease（IPD）based on the Movement Disorder Society clinical diagnostic criteria for Parkinson's Disease
- •Subjective feeling that Motor Symptoms（MS）of Parkinson's Disease （PD） were affected by seasonal variation (i.e., MS were more severe in winter than in summer) and improved after HTB
- •No change in the patient's PD medication regimen during the study
排除标准
- •Symptomatic bradycardia, severe postural hypotension, symptomatic coronary insufficiency, severe organic heart damage, severe cerebrovascular disease, and active psychosis
- •Dementia (Mini-Mental State Examination (MMSE) < 24 and Montreal Cognitive Assessment (MOCA) < 26)
- •Failure to cooperate with the study requirements and poor compliance
结局指标
主要结局
The Influence of Hyperthermic Baths on Motor Symptoms as Assessed by the Modified Webster Symptoms Score
时间窗: 3 week
The minimum and maximum values of Modified Webster Symptoms Score are 0 and 30 respectively, and higher scores mean a worse outcome.
The Influence of Hyperthermic Baths on Motor Symptoms as Assessed by the MDS-UPDRS Part III Motor Examination Total Scores Rating Scale
时间窗: 3 week
The minimum and maximum values of Movement Disorder Society - United Parkinson's Disease Rating Scale (MDS-UPDRS) part III motor examination total scores are 0 and 132 respectively, and higher scores mean a worse outcome.
次要结局
未报告次要终点