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Completed

NCT Number: NCT04165278

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Yingdong Zhang

Nanjing, Jiangsu, 210000, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

hyperthermic baths

Other

Taking hyperthermic baths

Primary outcomes

  1. The Influence of Hyperthermic Baths on Motor Symptoms as Assessed by the MDS-UPDRS Part III Motor Examination Total Scores Rating Scale

    Time frame: 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.

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

    Time frame: 3 week

    The minimum and maximum values of Modified Webster Symptoms Score are 0 and 30 respectively, and higher scores mean a worse outcome.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Nov 15, 2019
Registry last updated
Dec 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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