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Clinical Trials/NCT02418780
NCT02418780
Completed
Not Applicable

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

Harvard University Faculty of Medicine1 site in 1 country32 target enrollmentMay 2014

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Parkinson Disease
Sponsor
Harvard University Faculty of Medicine
Enrollment
32
Locations
1
Primary Endpoint
Retention
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
May 2014
End Date
April 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Harvard University Faculty of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Peter Wayne

Assistant Professor of Medicine

Harvard University Faculty of Medicine

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

Outcomes

Primary Outcomes

Retention

Time Frame: 6 months

The percentage of study visits completed by each participant.

Rate of participant recruitment

Time Frame: 24 months

Protocol adherence

Time Frame: 6 months

The percentage of Tai Chi classes attended and home practice completed by each participant randomized to the experimental arm.

Secondary Outcomes

  • Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS)(Baseline and 6 months)
  • Change from Baseline in PDQ-39(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 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)
  • Change from Baseline in Steady state gait dynamics(Baseline and 6 months)
  • Change from Baseline in Balance/Postural control(Baseline and 6 months)

Study Sites (1)

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