Tai Chi, Physiologic Complexity, and Healthy Aging

Phase 2

Completed

• Conditions: Healthy Aging
• Interventions: Behavioral: Tai Chi; Behavioral: Tai Chi Exercise

• Registration Number: NCT01340365
• Lead Sponsor: Harvard University Faculty of Medicine

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.

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-04-20
• Study First Submitted QC: 2011-04-21
• Study First Posted: 2011-04-22
• Primary Completion: 2013-10
• Study Completion: 2013-10
• Status Verified: 2013-11
• Last Update Submitted: 2013-11-26
• Last Update Posted: 2013-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Usual Care	Tai Chi	-
Tai Chi	Tai Chi Exercise	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.

Primary Outcome Measures

Name	Time	Method
Change in Center of Pressure complexity	0, 3 and 6 months	Center of pressure (COP) dynamics during quiet standing with eyes open
Change in Heart rate complexity	0, 3, and 6 months	Beat-to-beat variation measured using ECG for a 30 minute during seated quiet resting

Trial Locations

Locations (1)

Beth Israel Deaconess Medical Center; 🇺🇸 Brookline, Massachusetts, United States