Health Outcomes of Tai Chi in Subsidized Senior Housing
Phase: NA
Conditions: Aging
Sponsor: Hebrew SeniorLife

            Institutional Review Board 
 
 
Phone: 617‐971‐5365 
            1200 Centre Street                        
 
 
Fax: 617‐971‐5350 
             Boston, MA 02131 
 
 
E‐mail: irb@hsl.harvard.edu 
 
1 
Protocol Form 
Version Date: 5/9/12 
 
Protocol Form for Non‐Exempt Research 
Complete each question. If a question is not applicable, put N/A in the shaded text box. 
 
1. 
GENERAL INFORMATION 
 
 Initial Submission 
 Revised; HSL Protocol #:   14-014 
Version Number 
& Date 
Version #:  9
Date: 10/27/2017 
Principal Investigator 
Lewis A. Lipsitz, MD and Peter Wayne, PhD 
Protocol Title 
Health Outcomes of Tai Chi in Senior Supportive Housing (Mi-
WiSH Study  Mind Body - Wellness in Supportive Housing 
Study)  
Sponsor/Funding 
National Institute of Aging
2. 
BACKGROUND 
2.1 
Background and rationale for research based on existing literature:  
The rapid growth of the US population over age 80 that is expected to occur over the next 
20 years will create enormous challenges to our health care system.  Many of these elderly 
individuals will develop physical and cognitive disabilities that will make it difficult for 
them to live independently. Moreover, as a result of their medical needs, loss of income, 
and/or limited pensions, many will be poor and dependent on government support for 
their housing and health care needs. Currently, approximately 15% of seniors or 3.5 million 
people in the US live at or below the poverty level (Salkin). Many of these people are 
“dually-eligible” Medicare and Medicaid beneficiaries and live in Federal or State 
subsidized supportive housing facilities.    Dually eligible beneficiaries are generally poor 
and frail with worse health status than other Medicare beneficiaries. They also tend to use 
more health care services, and account for a disproportionate share of Medicare spending, 
particularly for inpatient hospitalizations.1, 2 For example, dual eligible beneficiaries are 
1.6 times more likely to be hospitalized than non dual eligible beneficiaries.[From Misha 
Segal, Policy Insight Brief, 9-2011]1, 3 Older adults living in public housing are twice as 
likely — 57.3 percent vs. 26.9 percent — to report fair or poor health compared to those 
with no public housing experience. (Ethnicity and Disease.)  
Impact on scientific knowledge and clinical practice: Previous clinical trials have included 
highly selected populations of different ages, and interventions that have typically been 
limited to 12-24 weeks in duration and conducted in academic medical centers. Very few 
of these studies have involved poor, frail, and ethnically diverse elderly populations or 
employed long-term interventions based in community settings. Moreover, we are not 
aware of any studies that have directly evaluated impacts of Tai Chi on overall medical 
costs. The proposed study will determine whether Tai Chi is an effective and practical 
intervention to improve overall function and lower health care costs in an expensive, 
vulnerable population of seniors that is more representative of many US communities than 
those previously studied. If the results are favorable, our study will also provide the 
NCT02346136

            Institutional Review Board 
 
 
Phone: 617‐971‐5365 
            1200 Centre Street                        
 
 
Fax: 617‐971‐5350 
             Boston, MA 02131 
 
 
E‐mail: irb@hsl.harvard.edu 
 
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necessary training and protocol manuals to replicate Tai Chi programs in senior housing 
facilities across the nation to help prevent, better manage, and overcome frailty among 
seniors. 
Unlike several other practices that have beneficial effects on health and well-being, Tai Chi 
has several features that are particularly attractive in frail elderly populations and can 
improve compliance. First, previous studies, including our own, demonstrate that it is safe 
in patients with chronic disease. 8,45,53,57 The exercises can be tailored to the capabilities 
of the participant, yet still have beneficial effects. In addition, many studies report higher 
adherence to Tai Chi than the comparison group or conventional exercise. This is 
important, particularly when dealing with populations of patients with chronic disease 
who have difficulty engaging in and sustaining conventional exercise. The relaxing effects, 
social interactions, self-efficacy, and continually reinforcing physical and psychological 
benefits of Tai Chi are intrinsic features that will likely promote long-term adherence.65-
67 
It is often challenging to enroll sedentary older adults in exercise programs, especially those 
who are economically disadvantaged or not well educated. Moreover, once recruited, it 
requires concerted effort to maximize participation and retention rates in the program. This is 
especially the case for our Tai Chi trial, which includes a year-long intervention, making it the 
longest Tai Chi intervention investigated in the context of a clinical trial in the United States. 
Therefore, the goal for the new amendment is to document effective strategies for increasing 
activity levels among older adults with a sedentary lifestyle, as a means to reducing disability 
and improving overall health.   
2.2 
Previous (non-clinical, pre-clinical or clinical) studies leading up to and supporting the 
proposed research: 
Given the large and growing problem of supporting the health and health care needs of frail 
seniors living in subsidized housing, it is particularly important to identify interventions 
that can combat frailty, improve residents’ functional abilities, and ultimately reduce their 
health care costs. Tai Chi is a particularly promising intervention that has enormous 
promise for ameliorating many of the conditions that lead to poor health and excessive 
health care utilization. In our previous studies, we have shown that it can be practiced 
successfully and without adverse effects by frail seniors living in supportive housing 
facilities and can result in significant improvements in balance, gait, and functional ability 
after only 12 weeks. However, it remains to be determined whether a longer period of Tai 
Chi exercise can improve the health of poor, frail seniors and reduce their health care 
utilization and cost.  
 
Tai Chi is a mind-body exercise that originated in China, and that is growing in popularity 
in the West. It is based on slow intentional flowing movements, often coordinated with 
breathing and imagery, that aims to strengthen, relax and integrate the physical body and 
mind, and according to traditional Chinese medicine, enhance the natural flow of ‘qi’ (or 
life energy), improve health, and personal development.1,2 Surveys suggest that 
approximately 5 million Americans have practiced Tai Chi, and this number is 
increasing.3,4 Because of its reputed health benefits, apparent safety, low cost, and 
growing popularity, Tai Chi has become an increasingly recognized preventative and 
rehabilitative modality. Studies have shown that Tai Chi exercise can improve a number of 
medical conditions, including CHF,5-10 hypertension,11-13 hyperlipidemia,11,14,15 

            Institutional Review Board 
 
 
Phone: 617‐971‐5365 
            1200 Centre Street                        
 
 
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coronary artery disease,16-21 COPD,22-25 cardiorespiratory fitness,26-34 poor 
balance,35-40 reduced musculoskeletal strength and flexibility,26,31,32,35,41-44 
Parkinson’s disease,45 rheumatological conditions,46-55 cognitive decline,56-62 and 
overall mood.63 Several Tai Chi review articles have been published.64  
 
2.3 
Describe why this research is important and how it will contribute to existing 
knowledge:  
The proposed clinical trial will reinforce the concept that multi-system interventions are 
particularly beneficial in overcoming the chronic diseases and disabilities of older adults 
and will demonstrate the value of Tai Chi, as an effective, low cost, easily tolerated, 
universally available, yet currently underutilized intervention to improve the functional 
health of elderly people.  The study will also help dispel the myth that aging is associated 
with an inevitable and irreversible functional decline, by demonstrating the ability of frail 
seniors to engage in and benefit from Tai Chi exercise. 
 Innovation: The proposed research is innovative, in our opinion, because: 1) it is based on 
a unique conceptual model derived from complex systems theory, 2) it engages a 
previously understudied, underserved, and expensive population in a unique academic-
community partnership, and 3) it examines important economic and physiologic outcomes 
that have not been previously investigated, yet can lead to a better mechanistic 
understanding and downstream impact of our results. 
Unlike previous studies, we will examine health care utilization and costs as outcomes of 
our Tai Chi intervention, in addition to traditional physiological and functional indicators 
of health. We will also examine novel measures of physiologic complexity of gait and 
balance developed to determine whether the effect of Tai Chi on overall functional ability 
is associated with improvements in the complex dynamics of these underlying control 
systems. Finally, we will determine features that will help us scale and sustain the program 
in the future – factors that influence compliance and ways to empower the community 
itself by training future Tai Chi trainers who work and live in the housing facilities we 
study.   
Our results will add to the growing scientific literature to evaluate subjects’ experiences in 
clinical trials/programs to inform facilitators and barriers to adherence, engagement, and 
program satisfaction, and the processes that mediate health behavior change. 
3. 
STUDY LOCATION 
3.1 
Study Site(s):  
The study will emanate from HSL-IFAR, and the study will take place in multiple senior 
supportive housing sites in Boston, Brookline, Somerville and Lynn.  The Housing 
Authorities of three communities have provided letters of support, included in this 
application.   
3.2 
Principal Investigator’s experience conducting research at study site(s), if outside of 
HSL facilities:  
The Principal Investigator was the lead investigator for the MOBILIZE Boston Study, which 
recruited and followed longitudinally 765 volunteers over aged 70, who resided in the local 
communities, many of whom were residents of senior facilities in Brookline and elsewhere.  

            Institutional Review Board 
 
 
Phone: 617‐971‐5365 
            1200 Centre Street                        
 
 
Fax: 617‐971‐5350 
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Dr. Lipsitz has also worked collaboratively with the co-investigators in the past and each 
has significant expertise to contribute to the success of the current protocol.  Dr. Peter 
Wayne has lead many community Tai Chi Studies over the past several decades and 
collaborated previously with Dr. Lipsitz on a successful Tai Chi Intervention Study:  The 
TEACH Study HSL IRB protocol 10-005 
4 
STUDY OBJECTIVES 
               Provide study objectives/aims/hypotheses:
Overall Aim:  To conduct a cluster randomized controlled trial (RCT) of Tai Chi classes 
twice weekly (with interim video reinforcement), or health promotion educational classes 
and monthly social calls for 1 year in low-income elderly housing facilities in Brookline, 
Somerville, and Lynn Massachusetts.  
Specific Aim 1: To determine the effects of the Tai Chi intervention on functional 
performance over a one-year period in poor, multiethnic, and functionally-limited elderly 
residents of low income housing facilities.  To provide a similar level of attention and social 
engagement, the control group will participate in educational classes and monthly social 
calls. The primary functional outcome will be overall physical function as quantified by the 
Short Physical Performance Battery (SPPB). Secondary outcomes will include person-
centered measures, including specific aspects of physical function, cognition, psychological 
well-being, falls, exercise self-efficacy, and satisfaction with the intervention. We 
hypothesize that participation in the Tai Chi classes will improve outcomes within each of 
these domains as compared to educational classes and monthly social calls. 
Specific Aim 2: To determine the effects of the Tai Chi intervention on health care 
utilization and cost during the one-year periods during and following Tai Chi or 
educational classes in poor, multiethnic, elderly residents of subsidized housing facilities. 
The primary utilization outcomes will be emergency visits, hospitalizations, doctor visits, 
skilled nursing and nursing home admissions, and the total number of encounters. Cost 
outcomes will be total Medicare spending for hospital, emergency room, post-acute care, 
and physician or nurse office visits. We hypothesize that compared to the control 
intervention, the Tai Chi intervention will significantly reduce health care utilization and 
costs during the intervention period and one year afterward. 
 
 
We will work within the ongoing Tai Chi clinical trial to address the following 2 aims:  
Specific Aim 3: Determine demographic, social, psychological, and other factors that 
influence continuing participation in a year-long Tai Chi exercise intervention by residents of 
subsidized senior housing facilities in Boston through a series of focus groups for residents 
participating in and dropping out of the Tai Chi exercise program. 
Specific Aim 4: Examine the predictors of long-term adherence to the Tai Chi exercise 
program by assessing the relationship between baseline demographic, health, functional, and 
psychosocial subject characteristics, which are being collected in the trial, with subsequent 
adherence to the intervention. We will quantify adherence by the number of Tai Chi sessions 
attended and will determine the characteristics of those most likely to complete the program.  
 
 

            Institutional Review Board 
 
 
Phone: 617‐971‐5365 
            1200 Centre Street                        
 
 
Fax: 617‐971‐5350 
             Boston, MA 02131 
 
 
E‐mail: irb@hsl.harvard.edu 
 
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5 
STUDY DESIGN 
5.1 
Study design (e.g., double-blind, placebo-controlled, parallel design): 
We will address our aims by conducting a cluster randomized controlled trial (RCT) of 
twice weekly group Tai Chi exercise sessions plus self-practiced video-directed 
supplemental sessions vs. an organized healthy aging educational program plus monthly 
social telephone calls, in low income senior housing facilities located within three diverse 
communities surrounding Boston. This is a pragmatic trial, rather than a comparative 
effectiveness or mechanistic study, which aims to determine the functional and health care 
utilization outcomes of Tai Chi compared to one’s customary daily practices, while 
controlling for attention through the educational sessions. The added focus group sessions 
and withdrawal interviews are designed as a qualitative and descriptive study.  
5.2 
Study duration (total): 
The study duration is expected to be 5 years in total. 
A REVISED STUDY TIMELINE FOR COMPLETION OF FIELD ACTIVITIES AND DATA ANALYSIS IS ATTACHED. 
5.3 
Duration of study for participants:
Participants will be enrolled for about 26 months; The baseline assessment will occur 
within 4 weeks of the telephone screen; the study intervention of  Tai Chi or health aging 
educational program sessions will last for 12 months; followed by a follow up assessment 
to occur within 4 weeks of completing the study intervention (a midpoint assessment will 
occur at 6 months from the start of the intervention).  Participant visits will end at the 
follow up assessment, but Health Care Utilization data will be collected for the one year 
during the study intervention, and for one year following the completion of the 
intervention.  
 
 
For each of the group (Tai Chi or health educational program), we will conduct three 30-45 min. 
focus groups, one within the first four months of the intervention, one within the second four 
months of the intervention, one within the last four months of the intervention.  
 
For those who withdraw from the study, we will conduct individual interviews as close to the 
time of drop-out as possible. 
 
6 
PARTICIPANT SELECTION AND WITHDRAWAL
6.1 
Source of study participants:
Participants will be individuals aged > or = 60, living in a participating senior housing site 
6.2 
Total target number of participants to be enrolled: 
320 
 
Facility/Institution 
Unit (if applicable)
Number of Participants
Senior Supportive Housing in 
Boston, Brookline, Somerville 
and Lynn MA 
           
Approximately 20 
participants per site will be 
enrolled in 16 sites. 

            Institutional Review Board 
 
 
Phone: 617‐971‐5365 
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6.3 
Inclusion criteria: 
These include: living in low income senior housing facilities, age > or = 60, able to 
understand instructions in English, able to participate safely in Tai Chi exercises at least 
twice a week, expected to remain in the facility for 1 year,   
Inclusion criteria for the focus group: any participant stays in the study. 
Inclusion criteria for the withdrawal group: any participant drops off from the study. 
6.4 
Exclusion criteria: 
 Exclusion criteria will be: already participating in Tai Chi exercises, any unstable or 
terminal illness (e.g., unstable cardiovascular disease, active cancer, unstable COPD, 
advanced dementia, psychosis), inability to maintain posture sitting or standing, and the 
inability to hear, see, or understand Tai Chi instructions and assessment questions. We will 
briefly screen volunteers for their cognitive capacity over the telephone and accept those 
who can recall at least 2 of 3 words in 3 minutes, and 2 of 3 highlighted elements of the 
study protocol.  
6.5 
Participant recruitment (describe recruitment methods and submit any materials to be 
used to recruit participants): 
This study calls for recruiting 320 elderly individuals living in 16 subsidized senior housing 
facilities. The facility managers have all agreed to cooperate with this study, provide us 
with access to their residents, inform them about the study, and encourage participation. 
In addition, we will post information promoting the study, conduct public information 
sessions in each facility, place notices in all resident mailboxes and newsletters, and inform 
residents that they will be visited personally by research staff. We have contracted with 
the Center for Survey Research of the University of Massachusetts-Boston (CSR) to conduct 
door-to-door recruitment by having trained interviewers speak directly with potential 
study participants. CSR has experienced interviewers who are themselves older adults and 
can relate to and establish trust from older adult populations. Using similar door-to-door 
recruiting, CSR helped us recruit 765 seniors > 70 years of age from the local Boston 
metropolitan area for the MOBILIZE Boston study between 2006-2008.  
Subjects will be recruited and studied in 2 waves.  Recruitment will occur during the first 
6 months of each wave. If a resident agrees to participate, the recruiter will conduct a brief 
screen for inclusion and exclusion criteria.  If the volunteer passes the screen, their baseline 
assessment will be scheduled as soon as possible.  
WE WILL INTRODUCE THE FOCUS GROUP DURING THE REGULAR SESSION FIRST. WE WILL THEN SEND OUT AN 
INTRODUCTORY MAIL FOLLOWED BY A PHONE INVITATION TO RECRUIT THE PARTICIPANTS.  
FOR THOSE WITHDRAWAL FROM THE CLASS, WE WILL SEND OUT AN INTRODUCTORY MAIL FOLLOWED BY A 
PHONE INVITATION TO RECRUIT THE DROP‐OUTS.  

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Phone: 617‐971‐5365 
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RECRUITMENT FOR THE STUDY IS NOW DISCONTINUED, AS DETERMINED BY THE NIA, 
FOLLOWING THE DSMB MEETING AND FOLLOW UP DISCUSSIONS OF 10/25/17. 
6.6 
Procedures for obtaining informed consent, including who will obtain consent and the 
timing of consent from recruitment: 
  Informed consent will be obtained at the first study visit.   The Project Director or 
Research Assistant will review the details of the study and will review the entire informed 
consent document with the participant, either by asking the participant to follow along as 
the document is read or by having the document read to them.  After each section of the 
consent form, the participant will be asked if he/she has any questions.  Once the staff is 
confident that the participant understands all aspects, the participant will be asked to sign 
the form and will be given a copy to keep.  The participant will be given the contact 
information of the study team members and be encouraged to call at any time for any 
additional questions that may occur during the participant’s participation in the trial. 
Informed consent will be obtained in a private place in the housing facility in which the 
potential participant resides, either their own apartment, or another identified private 
location within the facility.  
The participant will be allowed to take as much time as they would like to decide about 
their participation in the study and may discuss the study with anyone that they wish 
before making a decision to participate.  Only participants capable of providing individual 
consent will be enrolled in the study.  
FOR THE FOCUS GROUP AND THE WITHDRAWAL GROUP, WE WILL RECEIVE THEIR VERBAL CONSENT.  
6.7 
Withdrawal of participants (anticipated circumstances when participants will be 
withdrawn without their consent, how participants will be withdrawn, including use of any 
collected data and follow-up with any new/pertinent information): 
The criteria for discontinuing a participant's participation include any Iife-threatening or 
potentially disabling event, including  hemodynamic collapse, stroke, transient ischemic 
attack, dysrhythmia, renal insufficiency, angina, myocardial infarction, anaphylaxis, acute 
hemorrhage, or hospitalization for acute illness.  If the participant recovers from a 
potentially serious event, he/she may re-enter the study if they are assessed safe to return.  
In this situation, we will ask the participant’s primary MD to assess the participant’s 
medical fitness to return to the study.  To do this, we will send the attached letter to the 
participant’s MD with the participant’s permission, and request that the MD sign off that it 
is medically safe for the participant to resume their participation in the study.  
PARTICIPANTS WHO HAVE BEEN ENROLLED IN WAVE 2, PAIR 3, WILL BE WITHDRAWN FROM THE 
STUDY, DUE TO THE DECISION OF THE NIA TO STOP THE TRIAL.   THESE PARTICIPANTS HAVE 
COMPLETED A BASELINE ASSESSMENT BUT WERE NEVER ENROLLED IN THE STUDY INTERVENTION.  A 
LETTER OF EXPLANATION TO BE SENT TO THESE PARTICIPANTS IS ATTACHED.  FOR PARTICIPANTS 
ENROLLED IN WAVE 2, PAIRS 1 AND 2, IN WHICH THE INTERVENTIONS WERE UNDERWAY, THE 
INTERVENTIONS WILL BE STOPPED, AND PARTICIPANTS WILL RECEIVE A LETTER OF EXPLANATION, 
ATTACHED.  
 

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6.8 
If the participants may have diminished capacity to provide informed consent or to 
understand study procedures (now or in the foreseeable future), describe additional 
safeguards to protect their rights and welfare, including how and when you will engage 
legally authorized representatives: 
Only participants capable of providing individual consent will be enrolled in the study.  To 
be sure the subject is capable of providing informed consent, we will briefly screen 
volunteers for their cognitive capacity before enrolling them and will accept those who can 
recall at least 2 of 3 words in 3 minutes and 2 of 3 key elements of the study protocol.   for 
participants with little or no formal education we will read the informed consent form with 
a family member present if the participant wishes, and an appropriate witness (the housing 
sites have a care advisor/social services advisor on site who can serve as the witness)  .  
For individuals with little or no formal education, we will ask participants to answer the 
following questions to assess their understanding and assure they are informed. 
1.  Can you tell me in your own words what this study is about, and what is involved if you 
participate?   2.  Is the study voluntary or do you have to participate?  If you choose to 
participate, do you have to stay in the study until it ends or can you withdraw whenever 
you would like or need to?    3.  Are there any benefits to you for participating in the study?  
(If yes, can you explain the benefits?)  Are there any risks to you for participating in the 
study? (If yes, can you explain the risks?)  4.  Have you had enough time to make your 
decision to participate?  5.  Do you have any questions about the study?    6.  Please explain 
how you will contact the study staff if you have any questions or problems during the study.  
 
6.9      Will non‐English speakers will be enrolled in the study?                                    
 Yes   
 
No 
If yes, confirm what language will be used to consent prospective study participants. If the 
language used to consent is not the same language used by study participants or their 
legally authorized representatives, describe what methods and materials will be used to 
confirm their understanding of the study: 
      
 
7 
STUDY PROCEDURES 
7.1 
Study visits including procedures/tests involved (e.g., blood test, x-rays, 
questionnaires. If numerous study visits and procedures are involved, include a study 
procedure timeline): 
The participant's Housing Site will be assigned by random, such as the flip of a coin, to 
participate in either a Tai Chi or Health and Wellness Activity study group.  The participant 
will be asked to take part in whatever group his/her housing site has been assigned.  
Participants in the Tai Chi Activity group will be asked to attend for one hour twice a week 
for twelve months, or a total of 96 classes.  Participants in the Health and Wellness Activity 
group will be asked to attend for one hour, once a month for a total of 12 classes.     
Study Groups:  The Tai Chi study group will be led by a certified Tai Chi instructor.  It will 
consist of warm-up exercises, stretches, and Tai Chi movements developed for use with 
older adults.  The participant will be asked to attend all of the classes in the assigned study 
group over the one year period.  He/She may also be asked to watch and follow along with 
a Tai Chi instructional video in his/her apartment at his/her convenience one or two times 
each week for 15-30 minutes.  If he/she does not have a video player, one will be provided 

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Phone: 617‐971‐5365 
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to use during your study enrollment.  The video will consist of warm-ups, seated stretches, 
and simplified Tai Chi movements.  The participant will be asked to keep a log of practice 
dates and times and bring this to class with them for review with the instructor, and will 
be  regularly collected. The Health and Wellness Activity study group will also be led by a 
trained instructor.  Activities will include lectures and discussions on healthcare topics of 
interest to older adults.  All sessions will take place in a common room of the housing 
facility.  The instructors will have access to water for participants and a phone in case of 
emergency.  PARTICIPANTS WHO ENROLLED IN WAVE 2, PAIR 3 WILL NOT TAKE PART 
IN EITHER OF THE STUDY INTERVENTIONS. 
Assessments:  Participants will be asked to complete an assessment described below on 3 
separate occasions.  The first assessment will occur before beginning the assigned activity 
group of either Tai Chi exercise sessions or Health and Wellness sessions, twice a week for 
one year.  The second assessment will occur six months (+/- 3 weeks) after beginning the 
sessions and the third assessment will occur twelve months (+/- 3 weeks) after beginning 
the sessions.   (Wave 2 , participants from Housing site pairs 1 and 2, participation will end 
following the second assessment at six months.   These participants will not be asked to 
complete a third assessment at twelve months.  This is due to the recent decision by the 
NIA and DSMB to stop the study intervention at this time.  Only these Wave 2 site pairs will 
have reached the point of the six month assessment at the time that the study intervention 
is stopped.)   It will take about two hours to complete each of these three assessments.  A 
trained research assistant will carry out the assessments which will take place in the 
participant's apartment or a private place at the housing facility. 
 
1.  Health Interview - At each of the three assessments, the participant will be asked 
questions about his/her health, medications, history of falls, whether he/she has had any 
hospitalizations or emergency room visits.  Height, weight, blood pressure and heart rate 
will be measured.  Participants will be asked questions about daily activities, mood, sleep, 
memory and balance. 
2.  Balance and Walking Test - Participants will be asked to perform several activities such 
as walk a few yards, stand up from a chair, and stand with one foot beside or in front of the 
other.  Participants will also be asked to walk at his/her own pace several times in a quiet 
hallway  while a trained research assistant walks with him/her for safety.   Participants 
will be asked to wear small wireless accelerometers, the size of a wristwatch (Mobility 
LabsTM) to capture gait, walking and balance data.  The monitors will be placed at the ankles 
and the waist, and attach quickly and easily like a wristwatch with a velcro strap.  During 
one of the walking trials, the participant will be asked to count outloud while they are 
walking.    Participants will be able to rest if needed during the test, and a chair will be 
available to sit down if he/she becomes tired.  He/She will be asked to stand  for one 
minute, up to six times.  During two of the one minute stands the participant will be asked 
to count out loud.  The wireless accelerometers will  measure how much he/she sways as 
he/she are standing still.  An experienced research assistant will be at his/her side at all 
times to ensure safety during all balance tests.   Participants will be able to rest as needed.  

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3. Handgrip strength - Participants will be asked to squeeze a handgrip device with his/her
dominant hand three times.  Participants will rest between each trial.  The handgrip device 
will measure strength in the handgrip and forearm.   
Pilot Testing:   Prior to the start of data collection at the housing sites, we will pilot test the 
above procedures, that is, the Health Interview, the Balance and Walking Tests, and the 
Handgrip strength test.  The purpose of the pilot testing is to train and certify the Research 
Assistants in the study procedures, to assure inter-rater reliability among RAs, and initially 
to refine the order of the study procedures for maximum efficiency.  We will ask up to 20 
volunteers to complete the pilot testing each year as needed to recertify staff or train newly 
hired staff in the study procedures.   Pilot study volunteers will not be potential study 
participants.   
Monthly Phone Calls – A research assistant will call participants each month to check in 
with the particiant and to ask about any falls, hospitalizations or emergency room visits.  If 
the participant has a fall at any time over the course of the year that he/she is participating 
in the study, he/she will be asked a few questions about the fall, such as where he/she was 
and what he/she was doing at the time of the fall.  Health Care Service Utilization – 
Participants will be asked to provide his/her Medicare Unique Patient Identifier Number.   
In order to determine whether taking part in Tai Chi or Health and Wellness activities 
regularly for one year has any impact on needed health care services, such as doctor’s 
visits, hospitalizations or emergency room visits, we will request permission to track the 
participant's Health Care Service Utilization encounters over the course of the year that 
he/she are taking part in his/her assigned activity group and for one year following the 
completion of his/her assigned activity group.  
After the participants verbally consent to participate in the focus group, the focus group leader 
will use a discussion guide developed by the research team to explore how participants feel 
over these time periods, their motivation, social connections, sense of social support, 
satisfaction with the instructor, affect, and willingness to continue. For the drop-outs, the leader 
will also explore reasons for not participating. The discussion will be recorded and key themes 
will later be extracted using the qualitative procedure described below. These themes will be 
described in a publication and used to develop methods to promote adherence in future 
exercise interventions. 
Through an iterative process, we will use the immersion/crystallization technique to analyze 
the transcripts for themes. After each group session, the leader will summarize their 
impressions of the discussion and its major themes. All of the investigators will review each of 
the transcripts independently and develop coding categories to describe important segments.  
We will not restrict categories to those targeted by the discussion guide; each reviewer will 
develop categories from the content of the transcripts.  Second, we will hold a series of 
meetings to review each transcript together, discussing our different codes until we reach 
consensus. Finally, one investigator will review all coded segments, group them into themes, 
and identify quotations that illustrate the themes.   
7.2 
List procedures being performed as routine medical care (e.g. for diagnostic or 
treatment purposes): 
None of the procedures described above are being performed as routine medical care. 
 

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7.3 
List procedures being performed solely for the research:
All the procedures described in section 7.1 are being performed solely for the research. 
 
7.4 
Describe the methods used to protect participant privacy:
All study interviews will be conducted in a private space, either in the participant's 
apartment or a private area of the housing site.   
 
8 
STATISTICAL PLAN 
8.1 
Statistical methods: 
Analysis for each Aim:  Specific Aim 1: To determine the effects of the Tai Chi intervention 
on functional performance over a one-year period in poor, multiethnic, elderly residents of 
subsidized housing facilities. The primary functional outcome will be the Short Physical 
Performance Battery (SPPB) score.  We will also examine the effects of Tai Chi on self-
reported physical and mental health, gait and balance, falls, executive function, social 
engagement, overall activity level, and other patient-centered outcomes.  
The effect of the Tai Chi intervention on functional performance as measured by SPPB will 
be estimated from a shared-baseline linear mixed model with fixed effects for age, follow-
up time, age x time interaction, and treatment x time interaction and random effects of 
community, site within community, participant within site, community x treatment, 
community x time, community x treatment x time, site x time, and participant x time 
interactions. The shared baseline across treatment groups reflects homogeneity of the 
population with respect to treatment prior to random assignment and adjusts for effects 
of baseline level in a manner equivalent to ANCOVA. The random effects acknowledge the 
expected correlations among sites within a community, among participants within a site, 
and among repeated longitudinal assessments of each participant. This approach also 
naturally accommodates unequal enrollment across sites and loss to follow-up, even 
potentially informative loss to follow-up, if well predicted by the observed data on 
participants prior to drop-out. All participants will be included in the primary analysis 
according to their treatment assignment, following the intention-to-treat principle. 
Primary inference will be based on a two-tailed test at alpha = 0.023 of the fixed treatment 
x time interaction estimating Tai Chi-dependent improvement in rates of change in SPPB. 
An additional alpha = 0.002 is reserved for one interim analysis. The total two-tailed alpha 
= 0.025 for testing SPPB preserves an overall type I error rate of 0.05 for the functional and 
utilization primary aims.In addition to intention-to-treat analyses, we will perform 
secondary per-protocol analyses, defining participants in a tai chi group as 'per-protocol' 
if they attended ≥50% of tai chi classes averaged over the year-long intervention.  
Secondary continuous outcomes will be analyzed using the same model. Counts of falls will 
be analyzed in a similar mixed effect negative binomial regression. Both nominal p-values 
and step-down Bonferroni-adjusted p-values will be calculated for analyses of secondary 
outcomes. Secondary analyses will consider effects of treatment dose based on attendance 
records. Given the possible influence of perceived treatment efficacy on adherence, which 
could bias the effect of adherence on Tai Chi efficacy, these analyses will be exploratory. 
Other secondary analyses will determine if Tai Chi is more effective or uniquely effective 
for specific subgroups of participants by including fixed effects for subgroup indicators and 
their interactions with treatment, time, and treatment x time.  

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Specific Aim 2: To determine the effects of the Tai Chi intervention on health care 
utilization and Medicare cost in poor, multiethnic, elderly residents of subsidized housing 
facilities. The primary outcome is health care utilization, which includes number of 
emergency department (ED) visits, hospitalizations, doctor visits, skilled nursing and 
nursing home admissions, and the total number of encounters. The secondary outcome is 
total Medicare spending. These will be measured using Medicare claims. The effect of the 
Tai Chi intervention on both outcomes will be estimated in generalized linear mixed 
models according to the nature of each outcome measure. For primary analysis, count data 
(e.g., number of ED visits, hospitalizations, etc.) will be modeled as over-dispersed Poisson 
or negative binomial distributed outcomes. For secondary outcomes, Medicare claims 
amounts will be winsorized at the 5th and 80th percentiles of each year's distribution of 
costs to avoid distortion of estimates by the highest (and lowest) cost patients. Cost data 
will be modeled as log-normal or gamma distributed. All models will include fixed effects 
of treatment group, time period (one year before, one year during, and one year after the 
intervention) and treatment x period interaction and random effects of community, site 
within community, and community x treatment interaction and their interactions with 
period to accommodate covariance among residents within a given facility or community. 
Models will include additional fixed effects of age, sex, race, primary language, income, 
education, BMI, and history of falls to adjust for known predictors of health care utilization 
and cost. Linear contrasts on the treatment x period terms will be used to test for Tai Chi-
dependent change in annual per-person mean Medicare claim totals from the pre-
intervention to the intervention or post-intervention period. Inference will be based on a 
two-tailed test at alpha = 0.023, reserving alpha = 0.002 for one interim analysis, as in the 
analysis for Aim 1. Persistence of such an effect will be tested in a similar linear contrast 
between the intervention and post-intervention periods. Secondary analyses will test the 
effects of adherence and differential effects among subgroups using similar approaches to 
those for Aim 1. 
Interim analysis: One interim analysis for efficacy, futility, and sample size re-estimation is 
planned after all participants enrolled in wave 1 have completed their 12-month 
assessment (or dropped out). The study will be stopped for efficacy based on a two-sided 
Haybittle-Peto boundary at alpha = 0.002 for each co-primary outcome. A non-binding 
proposal to stop the study for futility will be based on a beta spending rule linear in 
information time, or beta = 0.10. The study will be stopped early for efficacy or futility only 
if both co-primary outcomes have demonstrated efficacy or futility. Observed drop-out and 
community-level, site-level, and participant-level variance components and their collective 
effect on the standard error of the treatment x time interaction term will be estimated. The 
benefit of increasing the number of sites or the number of participants per site will be 
considered based on the pre-specified minimum treatment effects of interest on SPPB and 
total health care utilization. Results of the efficacy and futility analysis will be shared only 
between an unblinded statistician and the DSMB. Estimates of the nuisance parameters 
and their effect on power for the pre-specified effect sizes will be shared with the study 
team given negligible risk of deducing the treatment effect and the importance of logistical 
constraints in planning any increase in sample size. 
DURING THE CLOSED SESSION OF THE MOST RECENT DSMB MEETING ON OCTOBER 20, 
2017, THE DSMB AND  NIA PROJECT OFFICER REVIEWED THE STUDY REPORT, 
INCLUDING SAFETY DATA AND A PREPLANNED INTERIM ANALYSIS FOR THE PRIMARY 

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OUTCOME, SPPB - SHORT PHYSICAL PERFORMANCE BATTERY - USING 12 MONTH WAVE 
1 DATA.  RESULTS OF THE A PRIORI DEFINED INTERIM ANALYSIS INDICATED THAT THE 
PRESPECIFIED BOUNDARY FOR THE TRIAL CESSATION DUE TO FUTILITY WAS CROSSED.  
GIVEN THAT THE STOPPING RULE FOR FUTILITY WAS SATISFIED, THE DSMB 
RECOMMENDED DISCONTINUING THE MI-WISH TRIAL.    
 
8.2 
Sample size determination (include power calculations or provide justification for their 
absence, e.g., pilot/feasibility study): 
Sample Size Calculation and Justification: Power for the primary analysis of SPPB (Short 
Physical Performance Battery) can be estimated by extrapolating results from our 
preliminary study in similar housing facilities where the mean baseline SPPB score was 8 
out of a total possible score of 12. In a mixed model ANCOVA of 3-month change in SPPB 
that included a site-level random effect of treatment, the standard error for the fixed effect 
of treatment was 0.268. Extrapolating from 3 months to 12 and from 2 sites to 16 (each 
study with 20 participants per site), the estimated standard error for a treatment effect on 
12-month change in SPPB would be 0.268 x 12/3 x sqrt(2/16) = 0.379. Given that estimate, 
the current study would have 85% power to detect a 1.38 point difference in 12-month 
change in SPPB based on a two-tailed test at alpha = 0.023. Even with up to 20% loss to 
follow-up, the study will be well powered to detect treatment-dependent differences in 12-
month change in SPPB of less than 2 points – a clinically meaningful difference. 
Power for effects of Tai Chi on health care utilization can be estimated from data collected 
in the COLLAGE Project at Hebrew SeniorLife and Kendall Corporation. Based on 90-day 
retrospective self reports from 668 residents of 22 housing and low-income housing sites, 
the mean rate of physician visits, overnight hospitalizations, and ED visits was 2.2 total 
encounters per person with an over-dispersion coefficient of 1.9, combining excess 
variation due to both person-to-person and site-to-site variation in underlying service 
needs. Given these estimates, our study will have 80% power to detect a 27% reduction in 
total encounters over 90-days for a two-tailed test at alpha = 0.05. Extrapolating 
conservatively to a mean annual total encounter rate of 6 encounters / person-year, the 
study would have 80% power to detect a reduction of just one encounter per year, 
assuming no increase in over-dispersion for the full-year counts. Even if over-dispersion 
increases 50% due to non-independence of successive 90-day intervals, the study would 
still have 80% power to detect a 20% reduction in mean annual total encounter rate. 
Previous studies of Tai Chi have reported a 30% reduction in fall rates, as well as 
improvements in many of the chronic illnesses (COPD, CHF, depression) that precipitate 
emergency, hospital, and doctor’s visits. While the minimum effects of Tai Chi on measures 
of health care utilization and cost that are detectable with high probability will be larger if 
we have under-estimated year-to-year or site-to-site variation, one goal of our interim 
analysis is to update our estimates of these nuisance parameters and re-calculate power. 
Power for the secondary cost outcome can be estimated by a two-group t-test on year-to-
year change in expenditures. Total Medicare expenditure data in 2011 from the Beacon 
Community Medicare Project, a national sample of communities of Medicare beneficiaries 
that is being evaluated by our Brandeis colleagues, had a person-level standard deviation 
(SD) after winsorizing at the 5th and 80th percentiles of $3,650. Year-over-year 

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correlations in physician visits, overnight hospitalizations, and ED visits, among the 
COLLAGE sample ranged from 0.32 to 0.51. Assuming a correlation of 0.40 between year-
over-year expenditures, the effective SD for the year-to-year change would be $3,650 x (2 
– 2 x 0.4) = $4,380 (we previously multiplied by 1 - 2 x 0. 2). From that estimate and an 
assumed intra-cluster correlation (ICC) of 0.05, we would have 80% power to detect a 
$2,352 reduction in total Medicare expenditures due to Tai Chi, based on a two-tailed test 
at alpha = 0.023 (to accommodate two interim analyses and two co-primary aims). This is 
a reasonable effect size given the positive effect of Tai Chi on health outcomes such as heart 
failure, COPD, falls, fractures, depression, and cognition. It represents a 26% reduction in 
total 2011 Medicare costs ($9,184) for people aged 65-90 with perceived health status of 
“fair” living in metropolitan statistical areas of the Northeast US (AHRQ Medical 
Expenditure Panel Survey (http://meps.ahrq.gov). The only previously reported reduction 
in costs due to Tai Chi was related to fall-related fractures, which averaged $1240/ 
person/year.   
8.3 
Data management (data collection and data entry):
Data will be gathered at the housing facilities through self- and researcher-administered 
questionnaires, functional assessments (e.g., SPPB and Get-up-and-go tests), interactive 
computer programs (e.g., Trails and other cognitive tests), physiologic monitoring 
equipment (e.g., balance platform, gait mat, dynamometer, stadiometer), and downloaded 
computer files (e.g. Medicare claims). All primary study data will be recorded with 
computer tablets on electronic case report forms (CRF) or as digital files generated from 
laboratory equipment. Confidentiality will be maintained by recording subject data using 
a unique subject identifier. Identifiable data, such as contact information and medical 
record numbers, will be recorded and stored separately from the clinical study data. Any 
paper-based study material and any identifiable data will be kept separately in a locked file 
cabinet accessible by authorized study staff only. All electronic CRF data will be stored 
securely in an electronic data capture and management system. Raw electronic 
instrumentation data will be organized and saved on a private network file dedicated to 
the research project. All documents and electronic data will be archived for a minimum of 
three years, or as required by HSL IRB and federal regulations, after the completion of the 
clinical trial. The study will be registered at clinicaltrials.gov.  
The Institute for Aging Research primarily employs the REDCap system to facilitate data 
managementoperations. REDCap is a full-featured clinical trials data management system 
(DMS) accessible to data entryand data analysis workstations using secure Web 
technologies. The REDCap product is developed and maintained by Vanderbilt University 
in cooperation with REDCap Consortium members including Hebrew SeniorLife. HSL hosts 
and maintains a dedicated instance of REDCap for use across our research enterprise. 
Each research study is provided separate project workspace in which all of the study data 
are stored in a MySQL relational database on the private corporate network behind several 
firewalls and located physically within the HSL data center  
9 
FORESEEABLE RISKS, POTENTIAL BENEFITS, COMPENSATION AND COSTS TO PARTICIPANTS
9.1 
Potential medical risks of study procedures:
There is a risk of feeling tired during the health interview, walking and balance or handgrip 
strength assessments.  The participant will be given breaks and will be told he/she may 

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also ask to take a break, or may stop at any time.  There is a small risk of feeling dizzy when  
standing up from a chair during the assessment.  If this occurs the participant may sit down 
again. A trained research assistant will be at the participant's side at all times during the 
assessments.  The participant will be made aware that he/she can refuse to complete a 
specific assessment, or if he/she becomes uncomfortable during an assessment, he/she 
should let the research assistant know and he/she will be allowed to skip or stop the 
assessment.    
There is a risk of muscle fatigue or soreness from the Tai Chi exercises.  This muscle 
soreness may last a few days.  There is a small risk of a fall during the exercises.  The Tai 
Chi groups will be limited to 20 persons and an experienced Tai Chi instructor will closely 
supervise each of the activities to minimize any risk of falling.   Chairs are provided and 
participants will be encouraged to rest whenever needed.  
9.2 
Psychosocial (non-medical) risks, discomforts, inconveniences:
None forseen 
9.3 
Potential benefits to individual participant:
Individual participants may benefit from the proposed study by learning about and 
possibly improving their health and function with health promotion recommendations and 
Tai Chi exercises.  Participants may also derive a sense of satisfaction and self-esteem from 
contributing to an increase in overall scientific knowledge of the benefits of Tai Chi exercise
9.4 
Potential benefits to study population, community, or society:
The proposed research is innovative, in our opinion, because: 1) it is based on a unique 
conceptual model derived from complex systems theory, 2) it engages a previously 
understudied, underserved, and expensive population in a unique academic-community 
partnership, and 3) it examines important physiologic and economic outcomes that have 
not been previously investigated, yet can lead to a better mechanistic understanding and 
downstream impact of our results. 
9.5 
Describe provisions for medical care and available compensation in the event of 
injury, if any: 
Any participant who develops adverse events during the conduct of study protocols will be 
given immediate medical care at their facility and, if indicated, emergency treatment 
according to the housing facility’s emergency plan.   The participant will be referred to their 
primary care physician for ongoing care. The Principal Investigator will be informed 
immediately of any adverse events that occur during the conduct of the study protocol.  
There is no compensation available in the event of an injury.  Cost for care in the event of 
an injury may be billed to the participant's insurance company.   We will try to have these 
costs paid for, but the participant may be responsible for some of them. For example, if the 
care is billed to the partcipant's insurer, he/she will be responsible for payment of any 
deductibles and co-payments required by the insurer. 
 
 
9.6 
Remuneration for participants (e.g.  goods, services, gift cards, cash, etc.): 
Participants will receive a check of $10 upon completion of the first assessment,, a second 
check of  $10  when they have reached the 6 month timepoint of the intervention, and 

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another  check of  $10 when they have completed the third and final assessment.  We will 
provide snacks after Tai Chi or educational sessions.  Small tokens such as pens, pins, 
magnets, and water bottles with the study logo will also be given out to acknowledge 
progress and reward participation and adherence.  
 
Participants in the focus group will receive a stipend of $15 per session so $45 for participating 
in three focus group sessions. Participants in the withdrawal group will receive a stipend of $15 
for taking part in the individual interview. The stipend will arrive in the form of a check within 3-
6 weeks following the completion of each session.  
9.7 
Describe any costs participants may incur during the study:
There will be no costs to participate in the study. 
 
10 
SAFETY ASSESSMENT AND STUDY MONITORING
10.1 
Definitions of adverse event and serious adverse event for the study: 
An adverse event (AE) is any untoward medical occurrence in a  participant, whether or 
not is is causally related to the study.  An AE can therefore be any unfavorable and 
unintended sign (including an abnormal laboratory finding, for example), symptom or 
disease temporally associated with the study.  Adverse events will be recorded on the 
appropriate case report forms and source documents. The investigator and/or trained staff 
member will evaluate all adverse events as to their severity and relation to the test article.  
The severity of adverse events will be graded as follows: 
Mild: Awareness of a sign or symptom but easily tolerated and are of minor irritant type 
causing no loss of time from normal activities.  Symptoms do not require therapy or a 
medical evaluation; signs and symptoms are transient. 
Moderate: Events introduce a low level of inconvenience or concern to the participant and 
may interfere with daily activities, but are usually improved by simple therapeutic 
measures; moderate experiences may cause some interference with functioning.   
Severe: Events interrupt the participant's normal daily activities and generally require 
systemic drug therapy or other treatment, they usually are incapacitating.     
Life Threatening: The participant was at immediate risk of death from the AE as it occurred.
Expectedness:  ADs must be assessed as to whether they were expected to occur or 
unexpected, meaning not anticipated based on current knowledge found in the protocol.  
Categories are: 
 
Unexpected - nature or severity of the event is not consistent with information 
about the condition under study or intervention in the protocol or consent form. 
 
Expected - event is known to be associated with the intervention or the condition 
under study. 
The Investigator will also assess the relationship of any adverse event to study, based upon 
available information, using the following guidelines: 
 
Definitely Related:  The adverse event is clearly related to the investigational 
procedure - i.e. an event that follows a reasonable temporal sequence from 

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Protocol Form 
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administration of the study intervention, follows a known or expected response 
pattern to the suspected intervention, that is confirmed by improvement or 
stopping and reappearance of the event on repeated exposure and that could not 
be reasonably explained by the known characteristics of the subject's clinical state.  
 
Possibly Related:  An adverse event that follows a reasonable temporal sequence 
from administration of the study intervention follows a known or expected 
response pattern to the suspected intervention, but that could readily have been 
produced by a number of other factors. 
 
Not Related:  The adverse event is clearly not related to the investigational 
agent/procedure - i.e. another cause of the event is most plausible; and/or a 
clinically plausible temporal sequence is inconsistent with the onset of the event 
and the study intervention and/or a causal relationship is considered biologically 
plausible.   
A serious adverse event is any experience that results in any of the following outcomes: 
• death, 
• is life threatening, 
• inpatient  hospitalization or prolongation of hospitalization, 
• a persistent or significant disability/incapacity. 
Important medical events that may not result in death, be life-threatening, or require 
hospitalization may be considered a serious adverse event when, based upon appropriate 
medical judgment, they may jeopardize the patient or participant and may require medical 
or surgical intervention to prevent one of the outcomes listed in this definition.  
10.2 
Adverse event (AE) reporting (method, distribution  and time frame): 
Adverse events will be reported to the Hebrew SeniorLife Institutional Review Board (IRB) 
and the NIA according to established guidelines. All serious adverse events (SAEs) will be 
reported promptly to the Safety Monitoring Board and the IRB, in accordance with IRB 
requirements.  
When SAE’s occur that are unanticipated they will be reported to the NIA Program 
Administrator and to the DSMB Chair or designated DSMB member within 48 hours of the 
study’s knowledge of the SAE.   A death would be reported expeditiously, within 24 hours 
of the study’s knowledge.  A summary of all other SAE’s will be reported to the NIA Program 
administrator and the DSMB quarterly, unless otherwise requested by the DSMB.   
Any participant who develops adverse events during the conduct of study protocols will be 
given immediate medical care at their facility and, if indicated, emergency treatment 
according to the housing facility’s emergency plan.   The participant will be referred to their 
primary care physician for ongoing care. The Principal Investigator will be informed 
immediately of any adverse events that occur during the conduct of the study protocol. 
10.3 
Process for data and safety monitoring:

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Safety monitoring procedures will be implemented and reviewed by a Data Safety 
Monitoring Board (DSMB), in accordance with NIA safety policies for human intervention 
studies. The criteria for discontinuing a participant's participation include the participant's 
request, as well as any Iife-threatening or potentially disabling event, including syncope, 
an injurious non-accidental fall, hemodynamic collapse, stroke, transient ischemic attack, 
dysrhythmia, renal insufficiency, angina, myocardial infarction, anaphylaxis, acute 
hemorrhage, or hospitalization for acute illness. These adverse events will be recorded and 
included in the database. If the participant recovers from a potentially serious event, 
he/she may re-enter the study if they are assessed safe to return.  In this situation, we will 
ask the participant's primary MD to assess the participant's medical fitness to return to the 
study.  To do this,  we will send the attached letter to the participant's MD,  with the 
participant's permission and request that the participant's MD sign off that it is medically 
safe for the participant to resume their participation in the study.  If a determination about 
continued participation cannot be made according to these criteria, the adverse event 
report will be faxed to the chair of the Data Safety Monitoring Board who will make a 
decision with members of the Board.  
A DSMB will be established for this project. This will consist of nationally recognized 
experts in geriatric medicine, biostatistics, senior housing, and clinical research. The 
chairperson will be an individual who is readily accessible for consultation in the local area. 
At the first meeting of the DSMB, members will review the study protocol and safety-
monitoring plan. 
 
 Prior to the start of the study the DSMB will review the IRB approved protocol and 
procedure manual, with regard to participant safety, recruitment, randomization, 
intervention, data management, quality control, and the informed consent document.   The 
Board will recommend any necessary changes of the protocol to the PIs and will review 
and approve revisions.  The Board will identify relevant data parameters and the format of 
the information to be regularly reported. 
  
The Board will then meet biannually to review standardized reports. They will review the 
progress of recruitment and retention of participants, compliance with the protocol, and 
operating procedures. If they raise concerns about safety issues, they may request 
additional data and propose specific analyses. They will make recommendations to the PI 
regarding recruitment, retention, compliance, and safety issues, and will send a written 
report to the Program Administrator following each meeting. The DSMB will be sent 
reports of research activity and summaries of safety monitoring information before each 
meeting. 
 
 
10.4 
If this is a multi‐site study, indicate how modifications of study procedures or 
materials will be communicated across sites, as well as communication of adverse 
events, or other issues affecting the research:  
This is not a multi-site study. 
 
11 
DATA HANDLING AND RECORD KEEPING (FOR BOTH PAPER AND ELECTRONIC DATA) 
Confidentiality of Data:  
 

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Phone: 617‐971‐5365 
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a. 
Identifiers to be stored with data:
Age, sex, Medicare Unique Patient Identifier number, BMI, medical conditions, measures of 
physical and cognitive function, falls, gait speed.  
 
b. 
If codes are to be assigned in the place of participant identifiers, storage location of 
key/links to codes: 
All data collected for analysis will be de-identified and labeled with participant numbers, 
which are assigned to the participants once they have enrolled into the study. Any 
identifiable information collected on paper, such as screening information and the consent 
form, will be stored in locked drawers.  
 
c. 
Study data storage location:  
Data will be stored at Hebrew SeniorLife, IFAR, in a locked storage cabinet to which only 
the site Principal Investigator, Dr. Lipsitz and the study coordinator have the key. Nobody 
other than the PI and study staff designated by the PI will have access to these drawers 
 
d. 
Data Security Measures: 
All de-identified electronic files are stored on password-protected, encrypted computers 
at Hebrew SeniorLife with access limited to the PI and designated study staff. All data will 
be accessible only by a password-protected server using the participant number.  A 
separate electronic file will contain the code linking the participant number to their 
identifiable information.  
 
e. 
Individuals who will have access to identifiable data, or key/link to codes: 
Only the PI and/or designated study staff will have access to identifiable data. 
 
f. 
Timing of destruction of materials containing identifiers and keys/links to codes: 
The current HSL Record Management, Retention, Disposition and Destruction Guidelines 
will be followed for this study.  Current guidelines are for records to be retained for at least 
3 years following completion of the study. 
 
g. 
Method for destroying materials with identifiers and keys/links to codes: 
Will follow HSL/IFAR standard protocol for research document disposal.  Materials with 
identifiers are placed in the locked boxes.  HSL subcontracts with Iron Mountain Secure 
Shredding which is AAA certified by the National Association for Information Destruction 
 
11.1 
List source of data (e.g., hospital records, clinical and office charts, checklists, pharmacy 
dispensing records, etc): 
Self report questionnaires, physical performance data, Falls record data, class attendance 
data, Medicare claims,  will be recorded directly to a secure de-identifed data file. 
11.2 
Record retention (e.g. where and for how long after study completion; for guidance, 
please see HSL’s Record Retention Policy): 
The current HSL Record Management, Retention, Disposition and Destruction Guidelines 
will be followed for this study.  Current guidelines are for records to be retained for at least 
3 years following completion of the study. 
 
12 
SENDING/RECEIVING SPECIMENS/DATA TO/FROM RESEARCH COLLABORATORS  
 

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Protocol Form 
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12.1     Specimens/data to be sent and/or received:
               Password protected and encrypted electronic data files will be sent/received for 1) 
Medicare claims from Dr. Cindy Thomas at Brandeis University  to Dr. Lipsitz in IFAR using secure 
web-based data transfer software available at HSL and 2) password protected and encrypted 
electronic data files will be sent from Dr. Lipsitz in IFAR using secure web-based data transfer 
software to Dr. Eric Macklin at MGH.  Dr. Macklin will guide and conduct statistical analyses. 
 
12.2    Who will send and/or receive data:
               Drs Cindy Thomas will send Medicare claims data to Dr. Lipsitz to connect with subject 
materials on file at HSL, and Dr. Eric Macklin will receive data files for statistical analysis.  
 
12.3     How will specimens/data be transported:
               Data will be transported via password protected and encrypted elctronic data files using 
secure web-based data transfer software. 
 
12.4     Do you expect to use data or specimens collected as part of this research for other,
               future research projects?                                                                                                 
 Yes   
 
No 
               If yes, be sure to include authorization for future use in the consent form. 
13 
DISSEMINATION OF RESULTS 
 
13.1 
Publication plan (if not addressed in a separate agreement):
This study will be registered at Clinical Trails.gov. Following its completion, we will publish 
our results in peer-reviewed medical research journals and prepare a detailed Training 
and Protocol Manual on how to implement the Tai Chi intervention in senior housing 
facilities. This will be made available for free on the National Council on Aging website for 
other institutions seeking to replicate our Intervention.  
13.2 
Plan to share individual and/or aggregate results with participants (e.g., results 
letter): 
Participants will receive newsletters about aggregate results at certain milestones, for 
example, once data collection is completed, or when results are published. 
14 
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            Institutional Review Board 
 
 
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Version Date: 5/9/12 
 
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            Institutional Review Board 
 
 
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15 
ATTACHMENTS (RECRUITMENT & CONSENT MATERIALS, SURVEYS, INTERVIEW QUESTIONS, ETC)