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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT06221904
Other study ID # 2024-KY-0116
Secondary ID
Status Withdrawn
Phase N/A
First received
Last updated
Start date January 20, 2024
Est. completion date February 28, 2024

Study information

Verified date March 2024
Source People's Hospital of Zhengzhou University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date February 28, 2024
Est. primary completion date February 20, 2024
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
China Tielu Community Kai Feng Henan

Sponsors (1)

Lead Sponsor Collaborator
Zeng Changhao

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Unified Parkinson's Disease Rating Scale The score of the Unified Parkinson's Disease Rating Scale ranges 0 to 199 points. 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 more severe symptoms and functional impairments. 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 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.
day 1 and day 21
Secondary 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. day 1 and day 21
Secondary 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. day 1 and day 21
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