Tai Chi, Physiologic Complexity, and Healthy Aging

Healthy Aging Clinical Trial

Official title:

Tai Chi, Physiologic Complexity, and Healthy Aging

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01340365
• Other study ID #: 2010P-000279
• Status: Completed
• Phase: Phase 2
• First received: April 20, 2011
• Last updated: November 26, 2013
• Start date: March 2011
• Est. completion date: October 2013

Study information

• Verified date: November 2013
• Source: Harvard University Faculty of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: October 2013
• Est. primary completion date: October 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 50 Years to 79 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy Aging

Intervention

Behavioral:
• Tai Chi Exercise
Practicing Tai Chi exercise 4 times a week for 6 months - twice in a classroom and twice independently
• 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.

Locations

Country	Name	City	State
United States	Beth Israel Deaconess Medical Center	Brookline	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Harvard University Faculty of Medicine	Beth Israel Deaconess Medical Center, Brigham and Women's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Heart rate complexity	Beat-to-beat variation measured using ECG for a 30 minute during seated quiet resting	0, 3, and 6 months	No
Primary	Change in Center of Pressure complexity	Center of pressure (COP) dynamics during quiet standing with eyes open	0, 3 and 6 months	No