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NCT Number: NCT01340365

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.

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Key information

Conditions

Healthy Aging

Age range

50 year–79 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Beth Israel Deaconess Medical Center

Brookline, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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

Treatment and study plan

Tai Chi Exercise

Behavioral

Practicing Tai Chi exercise 4 times a week for 6 months - twice in a classroom and twice independently

Tai Chi

Behavioral

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.

Primary outcomes

  1. 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

  2. Change in Center of Pressure complexity

    Time frame: 0, 3 and 6 months

    Center of pressure (COP) dynamics during quiet standing with eyes open

Sponsors and collaborators

Lead sponsor

Harvard University Faculty of Medicine

Other

Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital

Registry information

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Apr 22, 2011
Registry last updated
Nov 28, 2013

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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