NCT06221904

Brief 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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2024

Shorter than P25 for not_applicable parkinson-disease

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 16, 2024

Completed
4 days until next milestone

Study Start

First participant enrolled

January 20, 2024

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 24, 2024

Completed
27 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 20, 2024

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2024

Completed
Last Updated

March 12, 2024

Status Verified

March 1, 2024

Enrollment Period

1 month

First QC Date

January 16, 2024

Last Update Submit

March 8, 2024

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • The Berg Balance Scale

    day 1 and day 21

  • Patient Health Questionnaire-9

    day 1 and day 21

  • Generalized Anxiety Disorder-7

    day 1 and day 21

Study Arms (1)

The observation group

EXPERIMENTAL

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

Interventions

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.

The observation group

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tielu Community

Kaifeng, Henan, 475000, China

Location

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian DisordersBasal Ganglia DiseasesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Sumei Wang, Master

    Zhengzhou Tielu Hospital

    STUDY DIRECTOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Director

Study Record Dates

First Submitted

January 16, 2024

First Posted

January 24, 2024

Study Start

January 20, 2024

Primary Completion

February 20, 2024

Study Completion

February 28, 2024

Last Updated

March 12, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations