Effects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disease

Parkinson Disease Clinical Trial

Official title:

Effects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04165278
• Other study ID #: KY20190926-05
• Status: Completed
• Phase: N/A
• Start date: November 1, 2018
• Est. completion date: October 18, 2019

Study information

• Verified date: December 2020
• Source: Nanjing First Hospital, Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9
• Est. completion date: October 18, 2019
• Est. primary completion date: October 18, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fever
• Parkinson Disease

Intervention

Other:
• hyperthermic baths
Taking hyperthermic baths

Locations

Country	Name	City	State
China	Yingdong Zhang	Nanjing	Jiangsu

Sponsors (1)

Lead Sponsor	Collaborator
Nanjing First Hospital, Nanjing Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Influence of Hyperthermic Baths on Motor Symptoms as Assessed by the MDS-UPDRS Part III Motor Examination Total Scores Rating Scale	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.	3 week
Primary	The Influence of Hyperthermic Baths on Motor Symptoms as Assessed by the Modified Webster Symptoms Score	The minimum and maximum values of Modified Webster Symptoms Score are 0 and 30 respectively, and higher scores mean a worse outcome.	3 week