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Study of Tai Chi Exercise and Balance in Persons With Parkinson's Disease

This study is not yet open for participant recruitment.
Verified by National Institute of Neurological Disorders and Stroke (NINDS), February 2008

Sponsors and Collaborators: Oregon Research Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by: National Institute of Neurological Disorders and Stroke (NINDS)
ClinicalTrials.gov Identifier: NCT00611481
  Purpose

Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures of balance and secondary outcomes of physical performance.


Condition Intervention Phase
Parkinson's Disease
Behavioral: Tai Chi
Behavioral: Functional strength
Behavioral: Low-Impact Exercise Control
Phase II

Genetics Home Reference related topics:   familial paroxysmal nonkinesigenic dyskinesia    Parkinson disease   

MedlinePlus related topics:   Exercise and Physical Fitness    Parkinson's Disease   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Official Title:   Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease

Further study details as provided by National Institute of Neurological Disorders and Stroke (NINDS):

Primary Outcome Measures:
  • Balance, Gait [ Time Frame: 3 time points ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle strength, physical performance [ Time Frame: 3 time points ] [ Designated as safety issue: No ]

Estimated Enrollment:   100
Study Start Date:   May 2008
Estimated Study Completion Date:   December 2010
Estimated Primary Completion Date:   December 2010 (Final data collection date for primary outcome measure)

Arms Assigned Interventions
Tai Chi: Experimental
a set of pre-designed Tai Chi exercises
Behavioral: Tai Chi
a set of pre-designed Tai Chi Movements
B. Functional strength: Active Comparator Behavioral: Functional strength
a set of lower-extremety focused strength training exercises
C. Low-Impact Behavioral: Low-Impact Exercise Control
a set of chair-based low-impact exercises

Detailed Description:

The study is designed to determine the effects of Tai Chi training on balance and gait in persons with Parkinson's disease.

  Eligibility
Ages Eligible for Study:   40 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

Inclusion Criteria:

Patients who have:

  • A diagnosis of idiopathic PD, with a disease severity rating of stage I to III on the Hoehn and Yahr scale (Hoehn & Yahr, 1967)
  • At least 1 score of 2 or more for at least 1 limb for either the tremor, rigidity, or bradykinesia item of the Unified Parkinson's Disease Rating Scale (UPDRS)
  • Stable medication usage
  • Not participated in a structured exercise program (i.e., not involved in any routine, organized physical activity program lasting 30 minutes or more per day, such as a gym program or regularly scheduled instructor-led exercise class) in the previous 2 months
  • Ability to stand unaided or walk independently; had a personal physician's or neurologist's clearance for participation; and had a willingness to be assigned to intervention conditions.

Exclusion Criteria:

Patients who:

  • Participate in any other behavioral or pharmacological research study
  • Have cognitive decline (Mini-Mental State Examination score, ≤ 24) (Folstein et al., 1975)
  • Have self-reported diagnosis of Alzheimer disease or other severe neurological (stage III and IV PD)
  • Have evidence of progressive or debilitating conditions (metastatic cancer, severe heart or lung disease, crippling arthritis) or severe losses in vision and hearing that would limit their tolerance to testing and training procedures, that would interfere with study participation
  • Are unavailable during the study period.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00611481

Contacts
Contact: Fuzhong Li, Ph.D.     541-484-2123 ext 2137     fuzhongl@ori.org    
Contact: Peter Harmer, Ph.D.     503-370-6470     pharmer@willamette.edu    

Locations
United States, Oregon
Oregon Research Institute     Not yet recruiting
      Eugene, Oregon, United States, 97403
      Contact: Fuzhong Li, Ph.D.     541-484-2123 ext 2137     fuzhongl@ori.org    
      Principal Investigator: Fuzhong Li, Ph.D.            

Sponsors and Collaborators

Investigators
Principal Investigator:     Fuzhong Li, Ph.D.     Oregon Research Institute    
  More Information


Responsible Party:   Oregon Research Institute ( Fuzhong Li, Senior Research Scientist )
Study ID Numbers:   R01 NS047130, NS047130
First Received:   February 6, 2008
Last Updated:   February 6, 2008
ClinicalTrials.gov Identifier:   NCT00611481
Health Authority:   United States: Federal Government

Study placed in the following topic categories:
Ganglion Cysts
Movement Disorders
Parkinson Disease
Basal Ganglia Diseases
Central Nervous System Diseases
Parkinsonian Disorders
Neurodegenerative Diseases
Brain Diseases

Additional relevant MeSH terms:
Nervous System Diseases

ClinicalTrials.gov processed this record on October 15, 2008




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