Tai Chi for Enhancing Motor and Cognitive Function in Parkinson's Disease
- Conditions
- Parkinson Disease
- Interventions
- Other: Tai Chi
- Registration Number
- NCT02418780
- Lead Sponsor
- Harvard University Faculty of Medicine
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 32
- 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
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Diagnosis of any form of atypical parkinsonism
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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
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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
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Participation in brain stimulation within the past 3 months
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Family history of seizures or unexplained loss of consciousness
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Current history of dementia or severe psychiatric illness. Patients with mild (non-suicidal) depression and/or anxiety may be included
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Acute illness requiring hospitalization within past 3 months
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History of deep brain stimulation or other brain surgery
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Participation in brain stimulation within the past 3 months
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Regular use of walking aid
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Significant Tai Chi experience (> 6 months training in past 2 years)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Tai Chi Tai Chi 6-month Tai Chi training program combined with usual medical care
- Primary Outcome Measures
Name Time Method Rate of participant recruitment 24 months Retention 6 months The percentage of study visits completed by each participant.
Protocol adherence 6 months The percentage of Tai Chi classes attended and home practice completed by each participant randomized to the experimental arm.
- Secondary Outcome Measures
Name Time Method Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS) Baseline and 6 months Motor symptom severity
Change from Baseline in PDQ-39 Baseline and 6 months PD-related quality of life
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 Physical Activity Status Scale (PASS) 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 Cognitive function Baseline and 6 months Trail Making Test (TMT), The Digit Span Test, Controlled Oral Word Association Test (COWAT), Stroop Color-Word Test
Change from Baseline in Steady state gait dynamics Baseline and 6 months Steady state gait dynamics during 90 seconds of continuous over ground walking at preferred speed with and without use of dual task challenges
Change from Baseline in Balance/Postural control Baseline and 6 months Sway based measures of balance during quiet and tandem standing, with and without dual tasks
Trial Locations
- Locations (1)
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States