Back to resultsStudy of Tai Chi Exercise and Balance in Persons With Parkinson's Disease
Primary Purpose
Parkinson's Disease
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Strength training
Low-Impact Exercise Control
Sponsored by
About this trial
This is an interventional treatment trial for 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.
Sites / Locations
- Oregon Research Institute
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Active Comparator
Other
Arm Label
Tai Chi
B. Strength training
C. Low-Impact
Arm Description
Outcomes
Primary Outcome Measures
Balance
Secondary Outcome Measures
gait, physical performance, Unified Parkinson's Disease Rating Scale, falls, Muscle strength
Full Information
NCT ID
NCT00611481
First Posted
February 6, 2008
Last Updated
October 10, 2011
Sponsor
Oregon Research Institute
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
1. Study Identification
Unique Protocol Identification Number
NCT00611481
Brief Title
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
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
October 2008 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
August 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Oregon Research Institute
Collaborators
National Institute of Neurological Disorders and Stroke (NINDS)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
195 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi
Arm Type
Experimental
Arm Title
B. Strength training
Arm Type
Active Comparator
Arm Title
C. Low-Impact
Arm Type
Other
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
a set of pre-designed Tai Chi Movements
Intervention Type
Behavioral
Intervention Name(s)
Strength training
Intervention Description
Lower-extremity strength training exercises
Intervention Type
Behavioral
Intervention Name(s)
Low-Impact Exercise Control
Intervention Description
a set of chair-based low-impact exercises
Primary Outcome Measure Information:
Title
Balance
Time Frame
3 time points
Secondary Outcome Measure Information:
Title
gait, physical performance, Unified Parkinson's Disease Rating Scale, falls, Muscle strength
Time Frame
3 time points
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fuzhong Li, Ph.D.
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26226067
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.
Results Reference
derived
PubMed Identifier
22316445
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.
Results Reference
derived
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Study of Tai Chi Exercise and Balance in Persons With Parkinson's Disease
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