Effects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disease
Primary Purpose
Parkinson Disease
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
hyperthermic baths
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson Disease focused on measuring Parkinson's disease, temperature, hyperthermic baths, physiotherapy
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
Sites / Locations
- Yingdong Zhang
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Hyperthermic baths
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04165278
First Posted
November 14, 2019
Last Updated
December 24, 2020
Sponsor
Nanjing First Hospital, Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04165278
Brief Title
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
2. Study Status
Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
November 1, 2018 (Actual)
Primary Completion Date
October 18, 2019 (Actual)
Study Completion Date
October 18, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease
Keywords
Parkinson's disease, temperature, hyperthermic baths, physiotherapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a self-control study
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Hyperthermic baths
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
hyperthermic baths
Intervention Description
Taking hyperthermic baths
Primary Outcome Measure Information:
Title
The Influence of Hyperthermic Baths on Motor Symptoms as Assessed by the MDS-UPDRS Part III Motor Examination Total Scores Rating Scale
Description
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.
Time Frame
3 week
Title
The Influence of Hyperthermic Baths on Motor Symptoms as Assessed by the Modified Webster Symptoms Score
Description
The minimum and maximum values of Modified Webster Symptoms Score are 0 and 30 respectively, and higher scores mean a worse outcome.
Time Frame
3 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yingdong Zhang, PhD
Organizational Affiliation
Nanjing Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Yingdong Zhang
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
we'll share our study design and the study results with other researchers
IPD Sharing Time Frame
the data will become available 12 months after the study finished for 1 year
IPD Sharing Access Criteria
clinical doctors
Learn more about this trial
Effects of Hyperthermic Baths on Motor Symptoms of Parkinson's Disease
We'll reach out to this number within 24 hrs