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Clinical Trials/NCT01340365
NCT01340365
Completed
Phase 2

Tai Chi, Physiologic Complexity, and Healthy Aging

Harvard University Faculty of Medicine1 site in 1 country60 target enrollmentMarch 2011
ConditionsHealthy Aging

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Healthy Aging
Sponsor
Harvard University Faculty of Medicine
Enrollment
60
Locations
1
Primary Endpoint
Change in Center of Pressure complexity
Status
Completed
Last Updated
12 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2011
End Date
October 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Harvard University Faculty of Medicine
Responsible Party
Principal Investigator
Principal Investigator

Peter Wayne

Assistant Professor in Medicine

Harvard University Faculty of Medicine

Eligibility 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

Outcomes

Primary Outcomes

Change in Center of Pressure complexity

Time Frame: 0, 3 and 6 months

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

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

Study Sites (1)

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