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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Oregon Research Institute
ClinicalTrials.gov Identifier:
NCT00611481
First received: February 6, 2008
Last updated: October 10, 2011
Last verified: October 2011

February 6, 2008
October 10, 2011
October 2008
May 2011   (final data collection date for primary outcome measure)
Balance [ Time Frame: 3 time points ] [ Designated as safety issue: No ]
Balance, Gait [ Time Frame: 3 time points ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00611481 on ClinicalTrials.gov Archive Site
gait, physical performance, Unified Parkinson's Disease Rating Scale, falls, Muscle strength [ Time Frame: 3 time points ] [ Designated as safety issue: No ]
Muscle strength, physical performance [ Time Frame: 3 time points ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Tai Chi Exercise and Balance in Persons With Parkinson's Disease
Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease

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.

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Parkinson's Disease
  • 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
  • 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
Li F, Harmer P, Fitzgerald K, Eckstrom E, Stock R, Galver J, Maddalozzo G, Batya SS. Tai chi and postural stability in patients with Parkinson's disease. N Engl J Med. 2012 Feb 9;366(6):511-9. doi: 10.1056/NEJMoa1107911.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
195
August 2011
May 2011   (final data collection date for primary outcome measure)

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.
Both
40 Years to 85 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00611481
R01 NS047130, R01NS047130, NS047130
Yes
Oregon Research Institute
Oregon Research Institute
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Fuzhong Li, Ph.D. Oregon Research Institute
Oregon Research Institute
October 2011

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