Parkinson Disease
Conditions
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.
Interventions
OTHERTai Chi
6-month Tai Chi exercise program meeting 2 times per week plus DVD for home practice
Sponsors
Spaulding Rehabilitation Hospital
Beth Israel Deaconess Medical Center
Harvard University Faculty of Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Rate of participant recruitment | 24 months | — |
| Protocol adherence | 6 months | The percentage of Tai Chi classes attended and home practice completed by each participant randomized to the experimental arm. |
| Retention | 6 months | The percentage of study visits completed by each participant. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 | 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 |
| 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 |
Countries
United States
Outcome results
None listed