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

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).

Study Overview

• Status: Completed
• Conditions: Parkinson Disease
• Intervention / Treatment: Other: Tai Chi

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.

• Study Type: Interventional
• Enrollment (Actual): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Brigham and Women's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Harvard University Faculty of Medicine
• Collaborators: Beth Israel Deaconess Medical Center; Spaulding Rehabilitation Hospital
• Investigators: Principal Investigator: Peter M Wayne, PhD, Harvard University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start: May 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: April 6, 2015
• First Submitted That Met QC Criteria: April 13, 2015
• First Posted (Estimate): April 16, 2015

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: August 18, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: 2013P002343