Clinical trial NCT00611481: Study of Tai Chi Exercise and Balance in Persons With Parkinson's Disease
Official title: Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Parkinson's Disease
Lead sponsor: Oregon Research Institute
Sponsor class: OTHER
Collaborators: name: National Institute of Neurological Disorders and Stroke (NINDS)
First posted: 2008-02-11
Enrollment: 195
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Balance
timeFrame: 3 time points
Secondary outcomes:
measure: gait, physical performance, Unified Parkinson's Disease Rating Scale, falls, Muscle strength
timeFrame: 3 time points
Other outcomes:
Locations:
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Fuzhong Li, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Li F, Harmer P. Economic Evaluation of a Tai Ji Quan Intervention to Reduce Falls in People With Parkinson Disease, Oregon, 2008-2011. Prev Chronic Dis. 2015 Jul 30;12:E120. doi: 10.5888/pcd12.140413.
citation: 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.