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

This study has been completed.

First Received on February 6, 2008. Last Updated on October 10, 2011 History of Changes

Sponsor:	Oregon Research Institute
Collaborator:	National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):	Oregon Research Institute
ClinicalTrials.gov Identifier:	NCT00611481

Purpose

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.

Condition	Intervention	Phase
Parkinson's Disease	Behavioral: Tai Chi Behavioral: Strength training Behavioral: Low-Impact Exercise Control	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease

Resource links provided by NLM:

Genetics Home Reference related topics: familial paroxysmal nonkinesigenic dyskinesia Perry syndrome

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

U.S. FDA Resources

Further study details as provided by Oregon Research Institute:

Primary Outcome Measures:

Balance [ Time Frame: 3 time points ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

gait, physical performance, Unified Parkinson's Disease Rating Scale, falls, Muscle strength [ Time Frame: 3 time points ] [ Designated as safety issue: No ]

Enrollment:	195
Study Start Date:	October 2008
Study Completion Date:	August 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Tai Chi	Behavioral: Tai Chi a set of pre-designed Tai Chi Movements
Active Comparator: B. Strength training	Behavioral: Strength training Lower-extremity 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 other functional outcomes in persons with Parkinson's disease.

Eligibility

Ages Eligible for Study:	40 Years to 85 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 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.

Contacts and Locations

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

Locations

United States, Oregon
Oregon Research Institute
Eugene, Oregon, United States, 97403

Sponsors and Collaborators

Oregon Research Institute

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator:

Fuzhong Li, Ph.D.

Oregon Research Institute

More Information

No publications provided by Oregon Research Institute

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

Responsible Party:	Oregon Research Institute
ClinicalTrials.gov Identifier:	NCT00611481 History of Changes
Other Study ID Numbers:	R01 NS047130, R01NS047130, NS047130
Study First Received:	February 6, 2008
Last Updated:	October 10, 2011
Health Authority:	United States: Federal Government

Additional relevant MeSH terms:

Parkinson Disease
Parkinsonian Disorders
Basal Ganglia Diseases
Brain Diseases

Central Nervous System Diseases
Nervous System Diseases
Movement Disorders
Neurodegenerative Diseases

ClinicalTrials.gov processed this record on May 22, 2012