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

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ClinicalTrials.gov Identifier: NCT00611481
Recruitment Status : Completed
First Posted : February 11, 2008
Last Update Posted : October 12, 2011
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Oregon Research Institute

Tracking Information
First Submitted Date  ICMJE February 6, 2008
First Posted Date  ICMJE February 11, 2008
Last Update Posted Date October 12, 2011
Study Start Date  ICMJE October 2008
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 10, 2011)
Balance [ Time Frame: 3 time points ]
Original Primary Outcome Measures  ICMJE
 (submitted: February 6, 2008)
Balance, Gait [ Time Frame: 3 time points ]
Change History Complete list of historical versions of study NCT00611481 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 10, 2011)
gait, physical performance, Unified Parkinson's Disease Rating Scale, falls, Muscle strength [ Time Frame: 3 time points ]
Original Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2008)
Muscle strength, physical performance [ Time Frame: 3 time points ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of Tai Chi Exercise and Balance in Persons With Parkinson's Disease
Official Title  ICMJE Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease
Brief Summary Patients practicing Tai Chi will exhibit significant improvements in primary outcome measures of balance, and secondary outcomes of gait, physical performance, Unified Parkinson's Disease Rating Scale, Falls, muscle strength.
Detailed Description The study is designed to determine the effects of Tai Chi training on balance and other functional outcomes in persons with Parkinson's disease.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Parkinson's Disease
Intervention  ICMJE
  • Behavioral: Tai Chi
    a set of pre-designed Tai Chi Movements
  • Behavioral: Strength training
    Lower-extremity strength training exercises
  • Behavioral: Low-Impact Exercise Control
    a set of chair-based low-impact exercises
Study Arms  ICMJE
  • Experimental: Tai Chi
    Intervention: Behavioral: Tai Chi
  • Active Comparator: B. Strength training
    Intervention: Behavioral: Strength training
  • C. Low-Impact
    Intervention: Behavioral: Low-Impact Exercise Control
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2011)
195
Original Estimated Enrollment  ICMJE
 (submitted: February 6, 2008)
100
Actual Study Completion Date  ICMJE August 2011
Actual Primary Completion Date May 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Patients who have:

  • A diagnosis of idiopathic PD, with a disease severity rating of stage I to IV 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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 40 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00611481
Other Study ID Numbers  ICMJE R01NS047130( U.S. NIH Grant/Contract )
R01NS047130 ( U.S. NIH Grant/Contract )
NS047130
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Oregon Research Institute
Study Sponsor  ICMJE Oregon Research Institute
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Fuzhong Li, Ph.D. Oregon Research Institute
PRS Account Oregon Research Institute
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP