Tai Chi for Enhancing Motor and Cognitive Function in Parkinson's Disease
1 other identifier
interventional
32
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable parkinson-disease
Started May 2014
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2014
CompletedFirst Submitted
Initial submission to the registry
April 6, 2015
CompletedFirst Posted
Study publicly available on registry
April 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2016
CompletedAugust 19, 2016
August 1, 2016
1.9 years
April 6, 2015
August 18, 2016
Conditions
Outcome Measures
Primary Outcomes (3)
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 Outcomes (11)
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 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
- +6 more secondary outcomes
Study Arms (2)
Tai Chi
EXPERIMENTAL6-month Tai Chi training program combined with usual medical care
Usual Care
NO INTERVENTIONWaitlist control group receiving usual medical care alone
Interventions
6-month Tai Chi exercise program meeting 2 times per week plus DVD for home practice
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Harvard University Faculty of Medicinelead
- Spaulding Rehabilitation Hospitalcollaborator
- Beth Israel Deaconess Medical Centercollaborator
Study Sites (1)
Brigham and Women's Hospital
Boston, Massachusetts, 02215, United States
Related Publications (2)
Ernst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2024 Apr 8;4(4):CD013856. doi: 10.1002/14651858.CD013856.pub3.
PMID: 38588457DERIVEDErnst M, Folkerts AK, Gollan R, Lieker E, Caro-Valenzuela J, Adams A, Cryns N, Monsef I, Dresen A, Roheger M, Eggers C, Skoetz N, Kalbe E. Physical exercise for people with Parkinson's disease: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2023 Jan 5;1(1):CD013856. doi: 10.1002/14651858.CD013856.pub2.
PMID: 36602886DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Peter M Wayne, PhD
Harvard University Faculty of Medicine
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor of Medicine
Study Record Dates
First Submitted
April 6, 2015
First Posted
April 16, 2015
Study Start
May 1, 2014
Primary Completion
April 1, 2016
Study Completion
April 1, 2016
Last Updated
August 19, 2016
Record last verified: 2016-08