Clinical trial NCT04165278: Effects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disease
Official title: Effects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Keywords: Parkinson's disease
temperature
hyperthermic baths
physiotherapy
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2019-11-15
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: a self-control study
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ≥ 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The Influence of Hyperthermic Baths on Motor Symptoms as Assessed by the MDS-UPDRS Part III Motor Examination Total Scores Rating Scale
timeFrame: 3 week
measure: The Influence of Hyperthermic Baths on Motor Symptoms as Assessed by the Modified Webster Symptoms Score
timeFrame: 3 week
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Yingdong Zhang
state: Jiangsu
Study officials:
affiliation: Nanjing Medical University
name: Yingdong Zhang, PhD
role: STUDY_DIRECTOR
References: