How Traditional Chinese Medicine Exercise Improves Parkinson Disease

How Traditional Chinese Medicine Exercise Improves Parkinson Disease: A Preliminary Study

The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

Study Overview

• Status: Not yet recruiting
• Conditions: Parkinson Disease
• Intervention / Treatment: Behavioral: Simple Gymnastics Training

Detailed Description

In the early stages of Parkinson's disease, many patients do not seek medical attention. The goal of this clinical trial is to explore the impact of Simple Gymnastics Training on Limb motor function and mental health in Parkinson's Patients in the Community (≥60 year old) with swallowing disorders. It primarily aims to address two key aspects: 1) the prevalence of Parkinson's Diseases among community-dwelling elderly individuals, and 2) the effects of Simple Gymnastics Training on Limb motor function and mental health in community-dwelling Parkinson's Patients. All patients are required to undergo a continuous three-week (21 days) Simple Gymnastics Training, with weekends off and training conducted only on weekdays. The training will be conducted two sessions per day, lasting 30 minutes each.

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Lavie Ce, Master; Phone Number: 15333828388; Email: 17695841016@163.com

Study Locations

• Thailand
  • Bangkok, Thailand
    • Thai-Z Uni Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age >60 years.
• Meeting the diagnostic criteria for Parkinson's disease developed by the Neurology Branch of the Chinese Medical Association in 2006.

Exclusion Criteria:

• Complicated with cognitive impairment or consciousness dysfunction.
• Simultaneously suffering from severe liver, kidney failure, tumors, or hematological diseases.
• Complicated with severe liver and kidney failure, tumors, or hematological disorders.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: The Simple Gymnastics Training group; The observation group is the only group.The elderly individuals will be arranged to undergo a continuous three-week (21 days) duration of Simple Gymnastics Training, with weekends off and training conducted only on weekdays, two sessions per day, each lasting 30 minutes. Each training session will be conducted approximately at 9.00 a.m. Apart from this,we require participants to only engage in daily activities and avoid strenuous and dangerous behaviors

Behavioral: Simple Gymnastics Training; This is a simple gymnastics training that includes body swings and waist twists, as well as exercises targeting the joints in the arms and legs in various directions. It aims to help Parkinson's patients improve their physical mobility. Each training session lasts for 30 minutes, with low intensity and easy to stick to.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Unified Parkinson's Disease Rating Scale	The score of the Unified Parkinson's Disease Rating Scale ranges 0 to 199 points. Higher scores reflect worse outcomes. This assessment tool includes items such as non-motor symptoms, motor function, activities of daily living, and complications, each with corresponding scoring criteria. Higher scores reflect worse outcomes. The scale is a commonly used assessment tool that can be used to evaluate the severity and progression of Parkinson's disease, as well as the effectiveness of rehabilitation treatment.	day 1 and day 21

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Berg Balance Scale	The Berg Balance Scale is a scale used to assess balance ability. It is widely used in rehabilitation and research for patients with Parkinson's disease and other movement disorders. The scale consists of 14 items, each involving different balance tasks and actions such as standing, turning, walking, and more. Each item is scored based on the performance level, ranging from 0 to 4, with a maximum total score of 56. Higher scores indicate better balance ability. The scale ranges 0 to 56. Higher scores indicate better outcomes.	day 1 and day 21
Patient Health Questionnaire-9	Patient Health Questionnaire-9 is a scale used to assess symptoms of depression, consisting of 9 items. Each item involves different aspects of depressive symptoms such as mood, sleep, appetite, etc. Each item is scored based on the frequency and severity of symptoms in the past two weeks, with a score range from 0 to 27. Higher scores indicate more severe symptoms. Patient Health Questionnaire-9 is widely used for screening and assessment of depression. The scores range from 0 to 27. Higher scores indicate more severe symptoms.	day 1 and day 21
Generalized Anxiety Disorder-7	Generalized Anxiety Disorder-7 is a scale used to assess symptoms of generalized anxiety disorder, consisting of 7 items. Each item involves different aspects of anxiety symptoms such as worry, tension, unease, etc. Each item is scored based on the frequency and severity of symptoms in the past two weeks, with a score range from 0 to 21. Higher scores indicate more severe symptoms. Generalized Anxiety Disorder-7 is widely used for screening and assessment of generalized anxiety disorder. The score ranges from 0 to 21. Higher scores indicate more severe symptoms.	day 1 and day 21

Collaborators and Investigators

• Sponsor: Muhammad
• Investigators: Study Chair: Nieto Luis, Master, Site Coordinator of United Medical Group

Study record dates

Study Major Dates

• Study Start (Estimated): November 1, 2024
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: March 5, 2024
• First Submitted That Met QC Criteria: March 5, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 15, 2024
• Last Update Submitted That Met QC Criteria: March 11, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: Commu-PKS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No