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

Parkinson Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02418780
• Other study ID #: 2013P002343
• Status: Completed
• Phase: N/A
• First received: April 6, 2015
• Last updated: August 18, 2016
• Start date: May 2014
• Est. completion date: April 2016

Study information

• Verified date: August 2016
• Source: Harvard University Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Other:
• Tai Chi
6-month Tai Chi exercise program meeting 2 times per week plus DVD for home practice

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Harvard University Faculty of Medicine	Beth Israel Deaconess Medical Center, Spaulding Rehabilitation Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of participant recruitment		24 months	No
Primary	Protocol adherence	The percentage of Tai Chi classes attended and home practice completed by each participant randomized to the experimental arm.	6 months	No
Primary	Retention	The percentage of study visits completed by each participant.	6 months	No
Secondary	Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS)	Motor symptom severity	Baseline and 6 months	No
Secondary	Change from Baseline in PDQ-39	PD-related quality of life	Baseline and 6 months	No
Secondary	Change from Baseline in Physical Activity Status Scale (PASS)		Baseline and 6 months	No
Secondary	Change from Baseline in Self-Efficacy for Exercise Scale		Baseline and 6 months	No
Secondary	Change from Baseline in Activity-specific Balance Confidence Scale		Baseline and 6 months	No
Secondary	Change from Baseline in Profile of Mood State		Baseline and 6 months	No
Secondary	Change from Baseline in Single leg stance time		Baseline and 6 months	No
Secondary	Change from Baseline in Timed Up and Go Test		Baseline and 6 months	No
Secondary	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	No
Secondary	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	No
Secondary	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	No