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

Not Applicable

Completed

• Conditions: Parkinson Disease

• Registration Number: NCT04165278
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study Start: 2018-11-01
• Primary Completion: 2019-10-18
• Study Completion: 2019-10-18
• Study First Submitted: 2019-11-14
• Study First Submitted QC: 2019-11-14
• Study First Posted: 2019-11-15
• Status Verified: 2020-12
• Last Update Submitted: 2020-12-24
• Last Update Posted: 2020-12-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 9

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
The Influence of Hyperthermic Baths on Motor Symptoms as Assessed by the Modified Webster Symptoms Score	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	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.

Trial Locations

Locations (1)

Yingdong Zhang; 🇨🇳 Nanjing, Jiangsu, China