Tai Chi, Physiologic Complexity, and Healthy Aging
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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 Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Tai Chi, Physiologic Complexity, and Healthy Aging |
- 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
| Estimated Enrollment: | 60 |
| Study Start Date: | March 2011 |
| Estimated Study Completion Date: | March 2014 |
| Estimated Primary Completion Date: | March 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| Ages Eligible for Study: | 50 Years to 79 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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| Contact: Jacquelyn Walsh | 617-732-6508 | JWALSH19@partners.org |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Recruiting |
| Brookline, Massachusetts, United States, 02215 | |
| Contact: Jacquelyn Walsh 617-732-6508 jwalsh19@partners.org | |
| Principal Investigator: | Peter M Wayne, PhD | Harvard Medical School |
More Information
No publications provided
| Responsible Party: | Peter Wayne, Assistant Professor in Medicine, Harvard University Faculty of Medicine |
| ClinicalTrials.gov Identifier: | NCT01340365 History of Changes |
| Other Study ID Numbers: | 2010P-000279 |
| Study First Received: | April 20, 2011 |
| Last Updated: | May 30, 2012 |
| Health Authority: | United States: Federal Government |
ClinicalTrials.gov processed this record on May 23, 2013