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

NCT ID: NCT04165278

Last Updated: 2020-12-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 9 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-11-01
• Study Completion Date: 2019-10-18

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.

Conditions

Parkinson Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Hyperthermic baths

On the first, third and fifth day of the first week, each subject will take the Hyperthermic Baths (HTB) at the same time. They will receive subjective measures before and after HTB. In the second week, no subjects accepted any intervention. On the fifteenth, seventeenth and nineteenth days of the third week, these subjects will receive two subjective measures without HTB in the same environment and scoring time as the experimental group.

Group Type: EXPERIMENTAL

hyperthermic baths

Intervention Type: OTHER

Taking hyperthermic baths

Interventions

hyperthermic baths

Taking hyperthermic baths

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Yingdong Zhang, PhD

Role: STUDY_DIRECTOR

Nanjing Medical University

Locations

Yingdong Zhang

Nanjing, Jiangsu, China

Countries

China

Other Identifiers

KY20190926-05

Identifier Type: -

Identifier Source: org_study_id