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

Parkinson's Disease Clinical Trial

Official title:

Phase II Study of Tai Chi Exercise in Relation to Balance in Persons With Parkinson's Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00611481
• Other study ID #: R01NS047130
• Secondary ID: R01NS047130NS047
• Status: Completed
• Phase: Phase 2
• First received: February 6, 2008
• Last updated: October 10, 2011
• Start date: October 2008
• Est. completion date: August 2011

Study information

• Verified date: October 2011
• Source: Oregon Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 195
• Est. completion date: August 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Behavioral:
• Tai Chi
a set of pre-designed Tai Chi Movements
• Strength training
Lower-extremity strength training exercises
• Low-Impact Exercise Control
a set of chair-based low-impact exercises

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Research Institute	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Balance		3 time points	No
Secondary	gait, physical performance, Unified Parkinson's Disease Rating Scale, falls, Muscle strength		3 time points	No