Clinical trial NCT02418780: Tai Chi for Enhancing Motor and Cognitive Function in Parkinson's Disease
Official title: Tai Chi for Enhancing Motor and Cognitive Function in Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Lead sponsor: Harvard University Faculty of Medicine
Sponsor class: OTHER
Collaborators: name: Spaulding Rehabilitation Hospital
name: Beth Israel Deaconess Medical Center
First posted: 2015-04-16
Enrollment: 32
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Rate of participant recruitment
timeFrame: 24 months
measure: Protocol adherence
timeFrame: 6 months
measure: Retention
timeFrame: 6 months
Secondary outcomes:
measure: Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS)
timeFrame: Baseline and 6 months
measure: Change from Baseline in PDQ-39
timeFrame: Baseline and 6 months
measure: Change from Baseline in Physical Activity Status Scale (PASS)
timeFrame: Baseline and 6 months
measure: Change from Baseline in Self-Efficacy for Exercise Scale
timeFrame: Baseline and 6 months
measure: Change from Baseline in Activity-specific Balance Confidence Scale
timeFrame: Baseline and 6 months
measure: Change from Baseline in Profile of Mood State
timeFrame: Baseline and 6 months
measure: Change from Baseline in Single leg stance time
timeFrame: Baseline and 6 months
measure: Change from Baseline in Timed Up and Go Test
timeFrame: Baseline and 6 months
measure: Change from Baseline in Steady state gait dynamics
timeFrame: Baseline and 6 months
measure: Change from Baseline in Balance/Postural control
timeFrame: Baseline and 6 months
measure: Change from Baseline in Cognitive function
timeFrame: Baseline and 6 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
Study officials:
affiliation: Harvard University Faculty of Medicine
name: Peter M Wayne, PhD
role: PRINCIPAL_INVESTIGATOR
References: