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Trial record 1 of 4 for:    Tai Chi and Wayne
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Tai Chi, Physiologic Complexity, and Healthy Aging

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01340365
First Posted: April 22, 2011
Last Update Posted: November 28, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Peter Wayne, Harvard University Faculty of Medicine
  Purpose
To evaluate the effects of Tai Chi—a mind-body exercise--on age-related loss of physiological complexity (using fractal and entropy based measures), and to understand the relationship between complexity, function and adaptability, we will conduct a two-arm prospective randomized clinical trial. Our overarching goal is to evaluate if six months of Tai Chi training, compared to a waitlist control receiving standard medical care, can enhance physiological complexity and adaptability in older Tai Chi-naïve adults. Secondary goals of the study are to characterize the relationship between complexity biomarkers, measures of function, and resilience. This pilot study will inform a future more definitive trial by providing information on recruitment and retention, compliance, dose-dependent effects, preliminary estimates of effect size, and the optimal biomarkers of complexity, function, and adaptive capacity.

Condition Intervention Phase
Healthy Aging Behavioral: Tai Chi Exercise Behavioral: Tai Chi Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Tai Chi, Physiologic Complexity, and Healthy Aging

Further study details as provided by Peter Wayne, Harvard University Faculty of Medicine:

Primary Outcome Measures:
  • Change in Heart rate complexity [ Time Frame: 0, 3, and 6 months ]
    Beat-to-beat variation measured using ECG for a 30 minute during seated quiet resting

  • Change in Center of Pressure complexity [ Time Frame: 0, 3 and 6 months ]
    Center of pressure (COP) dynamics during quiet standing with eyes open


Enrollment: 60
Study Start Date: March 2011
Study Completion Date: October 2013
Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Usual Care Behavioral: Tai Chi
Usual care, individuals attend testing sessions for 6 months with testing at times 0, 3, and 6 months. Individuals in Usual Care receive 3 months of Tai Chi at the study end.
Experimental: Tai Chi
Individuals will take part in community-based Tai Chi classes twice a week for 6 months as well as practice Tai Chi outside of class twice a week for the same 6 month period.
Behavioral: Tai Chi Exercise
Practicing Tai Chi exercise 4 times a week for 6 months - twice in a classroom and twice independently

Detailed Description:
Specific Aim #1: To determine if 6 months of Tai Chi training can increase complexity, function, and adaptive capacity of multiple physiological systems in older healthy adults. Specific Aim #2: To determine the relationships between biomarkers of physiological complexity, conventional measures of function and adaptive capacity. Statistical regression models will be used to determine relationships, both at baseline and overtime, between a) complexity biomarkers and measures of physical and cognitive function, and b) complexity biomarkers and adaptive capacity. Elucidating these relationships will further inform the interpretation of complexity biomarkers and provide insights into underlying component mechanisms contributing to complex physiological dynamics.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   50 Years to 79 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Ages 50-79
  • Living within the Greater Boston area
  • Willing to adhere to 6 month Tai Chi training protocol

Exclusion Criteria:

  • Chronic medical conditions, including: cardiovascular disease (myocardial infarction, angina, atrial fibrillation, or presence of a pacemaker), stroke, respiratory disease requiring daily use of an inhaler, diabetes mellitus, malignancies, neurological conditions (e.g., seizure disorder, Parkinson's, peripheral neuropathy), or other neuromuscular or musculoskeletal (requiring chronic use of pain medication) disease
  • Acute medical condition requiring hospitalization within the past 6 months
  • Self-reported (current) smoking or alcohol/drug abuse
  • Uncontrolled Hypertension (resting SBP > 160 or DBP > 100mm Hg)
  • Abnormal heart rate (resting HR > 100 bpm; <50bpm)
  • Abnormal ECG (supraventricular tachyarrhythmia, atrial fibrillation, significant ST wave abnormality, 2nd and 3rd degree heart block)
  • Pregnancy
  • Current use of prescription medications including cardio- or vaso-active drugs and medications that can affect autonomic function including Beta agonists and antagonists, drugs with anticholinergic properties (e.g. tricyclic antidepressants or anti psychotics), and cholinesterase inhibitor
  • Self-reported inability to walk continuously for 15 minutes unassisted
  • Regular Tai Chi practice within past 5 years
  • Regular participation in physical exercise on average 4 or more times per week
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01340365


Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Brookline, Massachusetts, United States, 02215
Sponsors and Collaborators
Harvard University Faculty of Medicine
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Investigators
Principal Investigator: Peter M Wayne, PhD Harvard Medical School