Tai Chi, Physiologic Complexity, and Healthy Aging

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Peter Wayne, Harvard University Faculty of Medicine
ClinicalTrials.gov Identifier:
NCT01340365
First received: April 20, 2011
Last updated: November 26, 2013
Last verified: November 2013

April 20, 2011
November 26, 2013
March 2011
October 2013   (final data collection date for primary outcome measure)
  • Change in Heart rate complexity [ Time Frame: 0, 3, and 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Center of pressure (COP) dynamics during quiet standing with eyes open
Same as current
Complete list of historical versions of study NCT01340365 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Tai Chi, Physiologic Complexity, and Healthy Aging
Tai Chi, Physiologic Complexity, and Healthy Aging

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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Healthy Aging
  • Behavioral: Tai Chi Exercise
    Practicing Tai Chi exercise 4 times a week for 6 months - twice in a classroom and twice independently
  • 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.
  • Usual Care
    Intervention: Behavioral: Tai Chi
  • 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.
    Intervention: Behavioral: Tai Chi Exercise
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
October 2013
October 2013   (final data collection date for primary outcome measure)

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
Both
50 Years to 79 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01340365
2010P-000279
Yes
Peter Wayne, Harvard University Faculty of Medicine
Harvard University Faculty of Medicine
  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital
Principal Investigator: Peter M Wayne, PhD Harvard Medical School
Harvard University Faculty of Medicine
November 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP