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

This study has been completed.

Sponsor:

Collaborator:

National Institute of Neurological Disorders and Stroke (NINDS)

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

History of Changes

Tracking Information

First Received Date ^ICMJE

February 6, 2008

Last Updated Date

October 10, 2011

Start Date ^ICMJE

October 2008

Primary Completion Date

May 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00611481 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

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

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

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

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (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 Arm (s)

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 *

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.

* 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

Enrollment ^ICMJE

195

Completion Date

August 2011

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.

Gender

Both

Ages

40 Years to 85 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00611481

Other Study ID Numbers ^ICMJE

R01 NS047130, R01NS047130, NS047130

Has Data Monitoring Committee

Yes

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

Information Provided By

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

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