Tai Chi for Enhancing Motor and Cognitive Function in Parkinson's Disease

Study Overview
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Brief Summary
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The purpose of this feasibility study is to preliminarily evaluate the effects of Tai Chi - a mind-body exercise - on motor and cognitive function as well as quality of life in individuals recently diagnosed with Parkinson's disease (PD).

Detailed Description
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Specific Aim 1: To assess the feasibility of recruiting and retaining individuals with PD into a 6-month randomized controlled trial of Tai Chi exercise. Specific Aim 2: To collect preliminary data on the efficacy of Tai Chi on improving gait and balance dynamics, physical and cognitive function, exercise activity, self-efficacy, mood, and quality of life in individuals with PD.

Official Title
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Tai Chi for Enhancing Motor and Cognitive Function in Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Other: Tai Chi


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Individuals recently diagnosed with idiopathic PD (≤ 10 years) Limited disease progression If taking PD-related medication, willingness to undergo baseline and follow-up testing while off medication Willingness to commit to the study protocols and complete Tai Chi program Willingness to be videotaped and audio-recorded during testing Exclusion Criteria: Diagnosis of any form of atypical parkinsonism History of: stroke, head trauma, brain tumor, brain injury, seizures or other central nervous system condition, orthopedic impairment or other disease that could likely contribute to a gait disturbance or parkinsonism Any severe, chronic condition or acute medical event for which participation in exercise programs is contraindicated (e.g. debilitating Rheumatoid Arthritis, history of frequent falls, unhealed fracture)** ** Unless the participant is able to obtain formal written approval from his/her treating physician granting permission to participate in our Tai Chi exercise program Participation in brain stimulation within the past 3 months Family history of seizures or unexplained loss of consciousness Current history of dementia or severe psychiatric illness. Patients with mild (non-suicidal) depression and/or anxiety may be included Acute illness requiring hospitalization within past 3 months History of deep brain stimulation or other brain surgery Participation in brain stimulation within the past 3 months Regular use of walking aid Significant Tai Chi experience (> 6 months training in past 2 years)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi<br>6-month Tai Chi training program combined with usual medical care | Other: Tai Chi<br>* 6-month Tai Chi exercise program meeting 2 times per week plus DVD for home practice<br>|
| No Intervention: Usual Care<br>Waitlist control group receiving usual medical care alone | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of participant recruitment |  | 24 months | 
| Protocol adherence | The percentage of Tai Chi classes attended and home practice completed by each participant randomized to the experimental arm. | 6 months | 
| Retention | The percentage of study visits completed by each participant. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) | Motor symptom severity | Baseline and 6 months | 
| Change from Baseline in PDQ-39 | PD-related quality of life | Baseline and 6 months | 
| Change from Baseline in Physical Activity Status Scale (PASS) |  | Baseline and 6 months | 
| Change from Baseline in Self-Efficacy for Exercise Scale |  | Baseline and 6 months | 
| Change from Baseline in Activity-specific Balance Confidence Scale |  | Baseline and 6 months | 
| Change from Baseline in Profile of Mood State |  | Baseline and 6 months | 
| Change from Baseline in Single leg stance time |  | Baseline and 6 months | 
| Change from Baseline in Timed Up and Go Test |  | Baseline and 6 months | 
| Change from Baseline in Steady state gait dynamics | Steady state gait dynamics during 90 seconds of continuous over ground walking at preferred speed with and without use of dual task challenges | Baseline and 6 months | 
| Change from Baseline in Balance/Postural control | Sway based measures of balance during quiet and tandem standing, with and without dual tasks | Baseline and 6 months | 
| Change from Baseline in Cognitive function | Trail Making Test (TMT), The Digit Span Test, Controlled Oral Word Association Test (COWAT), Stroop Color-Word Test | Baseline and 6 months |