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

NCT04165278 | Completed DMC

• 1 other identifier: KY20190926-05
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

Parkinson's disease; temperature; hyperthermic baths; physiotherapy

Outcome Measures

Primary Outcomes (2)

• 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

• 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

Study Arms (1)

Hyperthermic baths

EXPERIMENTAL

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.

Other: hyperthermic baths

Interventions

hyperthermic baths OTHER

Taking hyperthermic baths

Hyperthermic baths

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nanjing First Hospital, Nanjing Medical University: lead

Study Sites (1)

Yingdong Zhang

Nanjing, Jiangsu, 210000, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Yingdong Zhang, PhD

  Nanjing Medical University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: a self-control study

Study Record Dates

• First Submitted: November 14, 2019
• First Posted: November 15, 2019
• Study Start: November 1, 2018
• Primary Completion: October 18, 2019
• Study Completion: October 18, 2019
• Last Updated: December 29, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: the data will become available 12 months after the study finished for 1 year
• Access Criteria: clinical doctors

Locations

CN (1)