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Not yet recruitingNCT06303908Updated Mar 15, 2024

How Traditional Chinese Medicine Exercise Improves Parkinson Disease

An interventional study of Simple Gymnastics Training in Parkinson Disease, sponsored by Muhammad. Not yet recruiting. Open to participants aged 60 Years and older. Per ClinicalTrials.gov, last updated 2024-03-15.

Sponsored by Muhammad · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
60 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Parkinson Disease

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03

Who can participate

Ages eligible
60 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • 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

Interventions

  • BehavioralSimple 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.

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: day 1 and day 21

Secondary outcomes

  1. 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.

    Time frame: day 1 and day 21

  2. 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.

    Time frame: day 1 and day 21

  3. 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.

    Time frame: day 1 and day 21

06

Study locations

No study locations are listed for this record.

07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06303908
Lead sponsor
Muhammad
Responsible party
Muhammad (Research Director, Ahmadu Bello University Teaching Hospital) — Sponsor-investigator
First posted
Mar 12, 2024
Start date
Nov 2024 (estimated)
Primary completion
Dec 2024 (estimated)
Completion
Dec 2024 (estimated)
Last update
Mar 15, 2024

Study contacts

Lavie Ce, Master
Contact
17695841016@163.com
15333828388
Nieto Luis, Master
study chair · Site Coordinator of United Medical Group

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.

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