Healthy AgingPhase 2NCT01340365
Tai Chi, Physiologic Complexity, and Healthy Aging
A Phase 2 study testing Tai Chi Exercise and Tai Chi in people with Healthy Aging, run by Harvard University Faculty of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 50 to 79 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging
- What is being tested?
- Tai Chi Exercise and Tai Chi
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Oct 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 79 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Ages 50-79
- Living within the Greater Boston area
- Willing to adhere to 6 month Tai Chi training protocol
Who cannot join
- 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)
Show all 11Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Beth Israel Deaconess Medical Center
Brookline, Massachusetts, 02215
About this study
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.
Read the 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.
- Conditions
- Healthy Aging
- Being tested
- Tai Chi Exercise, Tai Chi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi ExerciseBehavioural
Practicing Tai Chi exercise 4 times a week for 6 months - twice in a classroom and twice independently
Tai ChiBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Other | Not described Receives: 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. Receives: Behavioral: Tai Chi Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Heart rate complexity
Beat-to-beat variation measured using ECG for a 30 minute during seated quiet resting
Measured: 0, 3, and 6 months
Change in Center of Pressure complexity
Center of pressure (COP) dynamics during quiet standing with eyes open
Measured: 0, 3 and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Healthy AgingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Harvard University Faculty of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Wayne, Harvard University Faculty of Medicine
- Investigators
- Peter M Wayne, PhD, Principal investigator, Harvard Medical School (HMS and HSDM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01340365
- Sponsor's protocol ID
- 2010P-000279
- Status last verified
- Nov 2013
- First submitted
- 20 Apr 2011
- Last updated
- 28 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 33481829Gow 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.
PubMed 29020106Walsh 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.
PubMed 26331103Wayne 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.
PubMed 25494333
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tai Chi, Physiologic Complexity, and Healthy Aging
- ClinicalTrials.gov ID
- NCT01340365
- Acronym / sponsor ID
- 2010P-000279
- Conditions
- Healthy Aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Harvard University Faculty of MedicineUniversity, hospital or other
- Collaborators
- Beth Israel Deaconess Medical Center, Brigham and Women's Hospital
- Study start
- Mar 2011
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 22 Apr 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Other | Behavioral: Tai Chi |
| Tai Chi | Experimental | Behavioral: Tai Chi ExerciseIndividuals 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. |
Who may qualify
- Ages
- 50 to 79 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Ages 50-79
- Living within the Greater Boston area
- Willing to adhere to 6 month Tai Chi training protocol
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi ExercisePracticing Tai Chi exercise 4 times a week for 6 months - twice in a classroom and twice independently | Behavioural | Tai Chi |
| Tai ChiUsual 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. | Behavioural | Usual Care |
Primary outcome
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
Change in Center of Pressure complexity
Time frame: 0, 3 and 6 months
Center of pressure (COP) dynamics during quiet standing with eyes open
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2013.
- Derived from this study: PubMed 33481829Wayne 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.
- Derived from this study: PubMed 29020106Gow 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.
- Derived from this study: PubMed 26331103Walsh 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.
- Derived from this study: PubMed 25494333Wayne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter M Wayne, PhD principal investigator
Harvard Medical School (HMS and HSDM)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tai Chi Exercise and Tai Chi in people with Healthy Aging, run by Harvard University Faculty of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Heart rate complexity (time frame: 0, 3, and 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01340365, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2013; AzTrials last refreshed its copy on 4 Nov 2026.