Tai Chi, Physiologic Complexity, and Healthy Aging

November 26, 2013 updated by: Peter Wayne, Harvard University Faculty of Medicine
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Brookline, Massachusetts, United States, 02215
        • Beth Israel Deaconess Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 79 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0, 3, and 6 months
Change in Center of Pressure complexity
Time Frame: 0, 3 and 6 months
Center of pressure (COP) dynamics during quiet standing with eyes open
0, 3 and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Harvard University Faculty of Medicine

Collaborators

Beth Israel Deaconess Medical Center
Brigham and Women's Hospital

Investigators

  • Principal Investigator: Peter M Wayne, PhD, Harvard Medical School (HMS and HSDM)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2011

Primary Completion (Actual)

October 1, 2013

Study Completion (Actual)

October 1, 2013

Study Registration Dates

First Submitted

April 20, 2011

First Submitted That Met QC Criteria

April 21, 2011

First Posted (Estimate)

April 22, 2011

Study Record Updates

Last Update Posted (Estimate)

November 28, 2013

Last Update Submitted That Met QC Criteria

November 26, 2013

Last Verified

November 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • 2010P-000279

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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