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

Primary Purpose

Parkinson Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Sponsored by
Harvard University Faculty of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Parkinson Disease

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Brigham and Women's Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Tai Chi

Usual Care

Arm Description

6-month Tai Chi training program combined with usual medical care

Waitlist control group receiving usual medical care alone

Outcomes

Primary Outcome Measures

Rate of participant recruitment
Protocol adherence
The percentage of Tai Chi classes attended and home practice completed by each participant randomized to the experimental arm.
Retention
The percentage of study visits completed by each participant.

Secondary Outcome Measures

Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS)
Motor symptom severity
Change from Baseline in PDQ-39
PD-related quality of life
Change from Baseline in Physical Activity Status Scale (PASS)
Change from Baseline in Self-Efficacy for Exercise Scale
Change from Baseline in Activity-specific Balance Confidence Scale
Change from Baseline in Profile of Mood State
Change from Baseline in Single leg stance time
Change from Baseline in Timed Up and Go Test
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
Change from Baseline in Balance/Postural control
Sway based measures of balance during quiet and tandem standing, with and without dual tasks
Change from Baseline in Cognitive function
Trail Making Test (TMT), The Digit Span Test, Controlled Oral Word Association Test (COWAT), Stroop Color-Word Test

Full Information

First Posted
April 6, 2015
Last Updated
August 18, 2016
Sponsor
Harvard University Faculty of Medicine
Collaborators
Spaulding Rehabilitation Hospital, Beth Israel Deaconess Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT02418780
Brief Title
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

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
May 2014 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Harvard University Faculty of Medicine
Collaborators
Spaulding Rehabilitation Hospital, Beth Israel Deaconess Medical Center

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson Disease

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
6-month Tai Chi training program combined with usual medical care
Arm Title
Usual Care
Arm Type
No Intervention
Arm Description
Waitlist control group receiving usual medical care alone
Intervention Type
Other
Intervention Name(s)
Tai Chi
Intervention Description
6-month Tai Chi exercise program meeting 2 times per week plus DVD for home practice
Primary Outcome Measure Information:
Title
Rate of participant recruitment
Time Frame
24 months
Title
Protocol adherence
Description
The percentage of Tai Chi classes attended and home practice completed by each participant randomized to the experimental arm.
Time Frame
6 months
Title
Retention
Description
The percentage of study visits completed by each participant.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS)
Description
Motor symptom severity
Time Frame
Baseline and 6 months
Title
Change from Baseline in PDQ-39
Description
PD-related quality of life
Time Frame
Baseline and 6 months
Title
Change from Baseline in Physical Activity Status Scale (PASS)
Time Frame
Baseline and 6 months
Title
Change from Baseline in Self-Efficacy for Exercise Scale
Time Frame
Baseline and 6 months
Title
Change from Baseline in Activity-specific Balance Confidence Scale
Time Frame
Baseline and 6 months
Title
Change from Baseline in Profile of Mood State
Time Frame
Baseline and 6 months
Title
Change from Baseline in Single leg stance time
Time Frame
Baseline and 6 months
Title
Change from Baseline in Timed Up and Go Test
Time Frame
Baseline and 6 months
Title
Change from Baseline in Steady state gait dynamics
Description
Steady state gait dynamics during 90 seconds of continuous over ground walking at preferred speed with and without use of dual task challenges
Time Frame
Baseline and 6 months
Title
Change from Baseline in Balance/Postural control
Description
Sway based measures of balance during quiet and tandem standing, with and without dual tasks
Time Frame
Baseline and 6 months
Title
Change from Baseline in Cognitive function
Description
Trail Making Test (TMT), The Digit Span Test, Controlled Oral Word Association Test (COWAT), Stroop Color-Word Test
Time Frame
Baseline and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter M Wayne, PhD
Organizational Affiliation
Harvard University Faculty of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States

12. IPD Sharing Statement

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

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