Tai Chi, Physiologic Complexity, and Healthy Aging

This study has been completed.
Sponsor:
Collaborators:
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Information provided by (Responsible Party):
Peter Wayne, Harvard University Faculty of Medicine
ClinicalTrials.gov Identifier:
NCT01340365
First received: April 20, 2011
Last updated: November 26, 2013
Last verified: November 2013
  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

Resource links provided by NLM:


Further study details as provided by Harvard University Faculty of Medicine:

Primary Outcome Measures:
  • 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


Enrollment: 60
Study Start Date: March 2011
Study Completion Date: October 2013
Primary Completion Date: October 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
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
  • Regular participation in physical exercise on average 4 or more times per week
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01340365

Locations
United States, Massachusetts
Beth Israel Deaconess Medical Center
Brookline, Massachusetts, United States, 02215
Sponsors and Collaborators
Harvard University Faculty of Medicine
Beth Israel Deaconess Medical Center
Brigham and Women's Hospital
Investigators
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: November 26, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 23, 2014