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Completed

NCT Number: NCT02418780

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).

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Key information

Age range

40 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Tai Chi

Other

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

Primary outcomes

  1. Rate of participant recruitment

    Time frame: 24 months

  2. 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.

  3. Retention

    Time frame: 6 months

    The percentage of study visits completed by each participant.

Secondary outcomes

  1. Change from Baseline in Unified Parkinson's Disease Rating Scale (UPDRS)

    Time frame: Baseline and 6 months

    Motor symptom severity

  2. Change from Baseline in PDQ-39

    Time frame: Baseline and 6 months

    PD-related quality of life

  3. Change from Baseline in Physical Activity Status Scale (PASS)

    Time frame: Baseline and 6 months

  4. Change from Baseline in Self-Efficacy for Exercise Scale

    Time frame: Baseline and 6 months

  5. Change from Baseline in Activity-specific Balance Confidence Scale

    Time frame: Baseline and 6 months

  6. Change from Baseline in Profile of Mood State

    Time frame: Baseline and 6 months

  7. Change from Baseline in Single leg stance time

    Time frame: Baseline and 6 months

  8. Change from Baseline in Timed Up and Go Test

    Time frame: Baseline and 6 months

  9. Change from Baseline in Steady state gait dynamics

    Time frame: Baseline and 6 months

    Steady state gait dynamics during 90 seconds of continuous over ground walking at preferred speed with and without use of dual task challenges

  10. Change from Baseline in Balance/Postural control

    Time frame: Baseline and 6 months

    Sway based measures of balance during quiet and tandem standing, with and without dual tasks

  11. Change from Baseline in Cognitive function

    Time frame: Baseline and 6 months

    Trail Making Test (TMT), The Digit Span Test, Controlled Oral Word Association Test (COWAT), Stroop Color-Word Test

Sponsors and collaborators

Lead sponsor

Harvard University Faculty of Medicine

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Spaulding Rehabilitation Hospital

Registry information

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Apr 16, 2015
Registry last updated
Aug 19, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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