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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for phase_2

Timeline

Completed

Started Mar 2011

Geographic Reach

1 country

1 active site

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

2.6 years study duration

Study Start

First participant enrolled

March 1, 2011

Completed

2 months until next milestone

First Submitted

Initial submission to the registry

April 20, 2011

Completed

2 days until next milestone

First Posted

Study publicly available on registry

April 22, 2011

Completed

2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2013

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed

Last Updated

November 28, 2013

Status Verified

November 1, 2013

Enrollment Period

2.6 years

First QC Date

April 20, 2011

Last Update Submit

November 26, 2013

Conditions

Healthy Aging

Outcome Measures

Primary Outcomes (2)

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
Change in Center of Pressure complexity
Center of pressure (COP) dynamics during quiet standing with eyes open
0, 3 and 6 months

Study Arms (2)

Usual Care

OTHER

Behavioral: Tai Chi

Tai Chi

EXPERIMENTAL

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

Interventions

Tai Chi ExerciseBEHAVIORAL

Practicing Tai Chi exercise 4 times a week for 6 months - twice in a classroom and twice independently

Tai Chi

Tai ChiBEHAVIORAL

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.

Usual Care

Eligibility Criteria

Age50 Years - 79 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Ages 50-79
Living within the Greater Boston area
Willing to adhere to 6 month Tai Chi training protocol

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Harvard University Faculty of Medicinelead
Beth Israel Deaconess Medical Centercollaborator
Brigham and Women's Hospitalcollaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Brookline, Massachusetts, 02215, United States

Location

Related Publications (4)

Wayne PM, Gow BJ, Hou F, Ma Y, Hausdorff JM, Lo J, Rist PM, Peng CK, Lipsitz LA, Novak V, Manor B. Tai Chi training's effect on lower extremity muscle co-contraction during single- and dual-task gait: Cross-sectional and randomized trial studies. PLoS One. 2021 Jan 22;16(1):e0242963. doi: 10.1371/journal.pone.0242963. eCollection 2021.
PMID: 33481829DERIVED
Gow BJ, Hausdorff JM, Manor B, Lipsitz LA, Macklin EA, Bonato P, Novak V, Peng CK, Ahn AC, Wayne PM. Can Tai Chi training impact fractal stride time dynamics, an index of gait health, in older adults? Cross-sectional and randomized trial studies. PLoS One. 2017 Oct 11;12(10):e0186212. doi: 10.1371/journal.pone.0186212. eCollection 2017.
PMID: 29020106DERIVED
Walsh JN, Manor B, Hausdorff J, Novak V, Lipsitz L, Gow B, Macklin EA, Peng CK, Wayne PM. Impact of Short- and Long-term Tai Chi Mind-Body Exercise Training on Cognitive Function in Healthy Adults: Results From a Hybrid Observational Study and Randomized Trial. Glob Adv Health Med. 2015 Jul;4(4):38-48. doi: 10.7453/gahmj.2015.058.
PMID: 26331103DERIVED
Wayne PM, Gow BJ, Costa MD, Peng CK, Lipsitz LA, Hausdorff JM, Davis RB, Walsh JN, Lough M, Novak V, Yeh GY, Ahn AC, Macklin EA, Manor B. Complexity-Based Measures Inform Effects of Tai Chi Training on Standing Postural Control: Cross-Sectional and Randomized Trial Studies. PLoS One. 2014 Dec 10;9(12):e114731. doi: 10.1371/journal.pone.0114731. eCollection 2014.
PMID: 25494333DERIVED

MeSH Terms

Interventions

Aquatic TherapyTai Ji

Intervention Hierarchy (Ancestors)

HydrotherapyPhysical Therapy ModalitiesTherapeuticsRehabilitationMind-Body TherapiesComplementary TherapiesExercise Movement Techniques

Study Officials

Peter M Wayne, PhD
Harvard Medical School (HMS and HSDM)
PRINCIPAL INVESTIGATOR

Study Design

Study Type: interventional
Phase: phase 2
Allocation: RANDOMIZED
Masking: SINGLE
Who Masked: OUTCOMES ASSESSOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: OTHER
Responsible Party: PRINCIPAL INVESTIGATOR
PI Title: Assistant Professor in Medicine

Study Record Dates

First Submitted

April 20, 2011

First Posted

April 22, 2011

Study Start

March 1, 2011

Primary Completion

October 1, 2013

Study Completion

October 1, 2013

Last Updated

November 28, 2013

Record last verified: 2013-11

Locations

US(1)

Brief Summary

Trial Health

Trial Health Score

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (2)

Study Arms (2)

Usual Care

Tai Chi

Interventions

Eligibility Criteria

You may qualify if:

You may not qualify if:

Sponsors & Collaborators

Study Sites (1)

Related Publications (4)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Study Design

Study Record Dates

Locations