AgingMi-WISHNCT02346136
Health Outcomes of Tai Chi in Subsidized Senior Housing
A study testing Tai Chi training in people with Aging, run by Hebrew SeniorLife at 1 site in United States.
Trial summary
The proposed study will determine whether Tai Chi is an effective and practical intervention to improve overall function and lower health care utilization in an expensive, vulnerable population of seniors that is more representative of many US communities than those previously studied. Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging
- What is being tested?
- Tai Chi training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to 26 Jan 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
- are fee-for-service Medicare Beneficiaries for the 3 study years
- Able to stand/walk independently, without the help of another person
Who cannot join
- enrolled in a Program of All-Inclusive Care for the Elderly (PACE), or a Special Needs Plan, since this would make it difficult to isolate the effects of Tai Chi on health care utilization.
- Practice of Tai Chi for >3 years over lifetime, or more than weekly in prior 6 months
- any unstable or terminal illness (e.g., unstable cardiovascular disease, active cancer, unstable chronic obstructive pulmonary disease (COPD), advanced dementia, psychosis)
- inability to maintain posture sitting or standing
- inability to hear, see, or understand Tai Chi instructions and assessment questions.
Trial locations and contacts
1 site in 1 country.
United States1 site
Hebrew Rehabilitation Center
Roslindale, Massachusetts, 02131
About this study
The proposed study will determine whether Tai Chi is an effective and practical intervention to improve overall function and lower health care utilization 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 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.
Read the detailed description
Elderly people living in low-income housing facilities represent one of our nation's largest, most functionally impaired, economically disadvantaged, and understudied populations that account for a disproportionate share of Medicare spending. This trial aims to test whether Tai Chi exercises improve the health and reduce the health care utilization of this population more than health education and social calls by conducting a cluster randomized controlled trial in 16 housing facilities in cities surrounding Boston. The proposal builds upon previously successful studies by Drs. Lipsitz, Wayne, and others showing multiple benefits of Tai Chi exercises in elderly people with a variety of diseases and disabilities. A randomized, controlled pilot study showed that 12 weeks of Tai Chi exercises tailored to the abilities of frail seniors living in supportive housing facilities can improve balance, gait, and physical function. The proposed study aims are to determine the effects of Tai Chi exercises conducted at least twice weekly over a 6-month period on 1) functional performance measured by the Short Physical Performance Battery and 2) health care utilization determined from self-reported emergency room visits and hospitalizations in poor, multiethnic, elderly residents of low income housing facilities. Secondary outcomes will include person-centered measures such as physical function, cognition, psychological well-being, falls, and self-efficacy. We hypothesize that compared to the control intervention, Tai Chi will significantly improve physical function and reduce health care utilization. This study will prepare the necessary training and protocol manuals for widespread dissemination of Tai Chi programs in housing facilities across the nation. It will also provide estimates of potential Medicare cost savings that can be used to justify future health insurance payments for this intervention.
- Conditions
- Aging
- Being tested
- Tai Chi training, Educational Control
- Keywords
- Tai Chi, Cluster randomized controlled trial, Intervention, Elderly, Mobility, Health care utilization
- Medical subject headings
- Patient Acceptance of Health Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai Chi trainingBehavioural
Educational ControlBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | This arm will receive a 6-month Tai Chi training intervention. Tai Chi training will include gentle dynamic stretching and strengthening, slow integrated movements, efficient posture, heightened body awareness and inner focus, active relaxation of body and mind, mindful diaphragmatic breathing, and healing imagery and intention. Participants will be asked to complete two formal group classes each week for at least 6 months, led by senior Tai Chi instructors. Additionally, participants will be given practice Digital Versatile Disc (DVD), DVD players if necessary, and instructions for daily home practice a minimum of 20 minutes on 3 non-class days each week. Receives: Behavioral: Tai Chi training |
| Educational Control | Active comparator | This arm will receive a 6-month educational control intervention. Participants will attend monthly educational group sessions within a common area of each housing facility. Sessions will be led by research personnel and include material from Patient Education Forms (PEFs) produced by the American Geriatric Society. Sessions will be semi-structured and contain approximately 30 minutes of lecture and 30 minutes of group discussion. Receives: Behavioral: Educational Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Short Physical Performance Battery (SPPB) Total Score
The Short Physical Performance Battery includes measures of standing balance (timing of tandem, semi-tandem, and side-by-side stands), 4-meter walking speed and the ability and time to rise from a chair 5 times. The minimum score = 0, the maximum score=12. A higher score means a better outcome.
Measured: Change from baseline to 6 months
Health Care Utilization
Health care utilization will be defined by counts of hospitalizations during the study period.
Measured: up to 12 months
Secondary outcomes (12)
Mobility
Mobility will be assessed by the Timed Up-and-Go, which records the time needed to stand from a chair, walk three meters, turn, walk back to the chair and sit down.
Measured: Change from baseline to 6 months
Gait Velocity
Gait velocity will be measured in meters/second (m/s) during two conditions: Normal walking (NW) and Dual task(DT) condition (counting backwards by 3's or 1's while walking)
Measured: Change from baseline to 6 months
Standing Balance
Standing balance will be assessed by recording 95% ellipse sway area with eyes open in meters squared (m2)
Measured: Change from baseline to 6 months
Grip Strength
Grip strength of the dominant hand will be assessed with a hand-grip dynamometer in kilograms (kg).
Measured: Change from baseline to 6 months
Self-reported Physical Activity
Self-reported physical activity will be assessed with the Physical Activity Scale for the Elderly (PASE). The range for this scale is 0-400, with higher score representing higher activity score (better outcome).
Measured: Change from baseline to 6 months
Executive Function
Executive function will be assessed with the Trail Making Test (TMT). Participants are timed while sequentially connecting a series of numbered circles (TMT part A), as well as connecting an alternating series of numbers and letters (e.g., A-1-B-2-C-3…) (TMT part B).
The outcome measure is the time difference in seconds between Part B and Part A.
Measured: Change from baseline to 6 months
Health-related Quality-of-life
Health-related quality-of-life will be assessed with the Short Form-12 (SF-12), which is a 12 item short form survey, a shortened version of the Short Form-36 (SF-36) health survey that is widely-utilized to assess physical and mental health, as well as the outcomes of healthcare services. The total score ranges from 0-100, with a lower score representing a better outcome for *both* the "Physical component" and "Mental Component"
Measured: Change from baseline to 6 months
Depression
Depressive symptoms will be assessed with the Center of Epidemiology Studies-Depression Scale Revised (CESD-R). The 20 item CESD-R test score range is between 0-60, with a lower score representing a better outcome.
Measured: Change from baseline to 6 months
Exercise Self-efficacy
Exercise self-efficacy will be assessed with a valid and reliable exercise self-efficacy questionnaire (Activities-specific Balance Confidence (ABC) score). The ABC score ranges from 0-100, with a higher score indicating a better outcome.
Measured: Change from baseline to 6 months
Falls
Falls will be defined as any event in which the participant unintentionally comes to rest on the ground or other lower level, not as a result of a major intrinsic event or an overwhelmingly external hazard. This outcome measure is reporting the sum total number of falls for each intervention.
Measured: 12 months
Health Care Utilization
Secondary health care utilization outcomes include counts of emergency room visits.
Measured: Baseline, 6 months and 12 months
Mini-Mental State Examination
The Mini-Mental State Questionnaire is a 30 point questionnaire that is used extensively to measure cognitive impairment. Total score = 30, score ranges are from 0 to 30. A higher score indicates better performance.
Measured: Change from baseline to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2015 (estimated)
- Study startJul 2015
- Primary completion10 Jan 2018
- Study completion26 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 180 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebrew SeniorLife
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital, Brandeis University, Massachusetts General Hospital, University of Massachusetts, Boston
- Responsible party
- Sponsor
- Investigators
- Lewis Lipsitz, MD, Principal investigator, Director, Marcus Institute for Aging Research, Hebrew SeniorLifePeter Wayne, PhD, Principal investigator, Research Director, Osher Center, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02346136
- Sponsor's protocol ID
- 2R01AG025037-09A1
- Acronym
- Mi-WISH
- Status last verified
- Apr 2018
- First submitted
- 20 Jan 2015
- Last updated
- 21 Feb 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Wayne PM, Gagnon MM, Macklin EA, Travison TG, Manor B, Lachman M, Thomas CP, Lipsitz LA. The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study: Design and rationale of a cluster randomized controlled trial of Tai Chi in senior housing. Contemp Clin Trials. 2017 Sep;60:96-104. doi: 10.1016/j.cct.2017.07.005. Epub 2017 Jul 8.
PubMed 28694204Lipsitz LA, Macklin EA, Travison TG, Manor B, Gagnon P, Tsai T, Aizpurua II, Lo OY, Wayne PM. A Cluster Randomized Trial of Tai Chi vs Health Education in Subsidized Housing: The MI-WiSH Study. J Am Geriatr Soc. 2019 Sep;67(9):1812-1819. doi: 10.1111/jgs.15986. Epub 2019 May 22.
PubMed 31116883
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Health Outcomes of Tai Chi in Subsidized Senior Housing
- ClinicalTrials.gov ID
- NCT02346136
- Acronym / sponsor ID
- Mi-WISH / 2R01AG025037-09A1
- Conditions
- Aging
- Keywords
- Tai Chi, Cluster randomized controlled trial, Intervention, Elderly, Mobility, Health care utilization
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 180 participants (actual)
- Lead sponsor
- Hebrew SeniorLifeUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital, Brandeis University, Massachusetts General Hospital, University of Massachusetts, Boston
- Study start
- Jul 2015
- Primary completion
- 10 Jan 2018 (actual)
- Study completion
- 26 Jan 2018 (actual)
- First posted
- 26 Jan 2015 (estimated)
- Results
- Posted 21 Feb 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed study will determine whether Tai Chi is an effective and practical intervention to improve overall function and lower health care utilization 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 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.
Detailed description
Elderly people living in low-income housing facilities represent one of our nation's largest, most functionally impaired, economically disadvantaged, and understudied populations that account for a disproportionate share of Medicare spending. This trial aims to test whether Tai Chi exercises improve the health and reduce the health care utilization of this population more than health education and social calls by conducting a cluster randomized controlled trial in 16 housing facilities in cities surrounding Boston. The proposal builds upon previously successful studies by Drs. Lipsitz, Wayne, and others showing multiple benefits of Tai Chi exercises in elderly people with a variety of diseases and disabilities. A randomized, controlled pilot study showed that 12 weeks of Tai Chi exercises tailored to the abilities of frail seniors living in supportive housing facilities can improve balance, gait, and physical function. The proposed study aims are to determine the effects of Tai Chi exercises conducted at least twice weekly over a 6-month period on 1) functional performance measured by the Short Physical Performance Battery and 2) health care utilization determined from self-reported emergency room visits and hospitalizations in poor, multiethnic, elderly residents of low income housing facilities. Secondary outcomes will include person-centered measures such as physical function, cognition, psychological well-being, falls, and self-efficacy. We hypothesize that compared to the control intervention, Tai Chi will significantly improve physical function and reduce health care utilization. This study will prepare the necessary training and protocol manuals for widespread dissemination of Tai Chi programs in housing facilities across the nation. It will also provide estimates of potential Medicare cost savings that can be used to justify future health insurance payments for this intervention.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai Chi trainingThis arm will receive a 6-month Tai Chi training intervention. Tai Chi training will include gentle dynamic stretching and strengthening, slow integrated movements, efficient posture, heightened body awareness and inner focus, active relaxation of body and mind, mindful diaphragmatic breathing, and healing imagery and intention. Participants will be asked to complete two formal group classes each week for at least 6 months, led by senior Tai Chi instructors. Additionally, participants will be given practice Digital Versatile Disc (DVD), DVD players if necessary, and instructions for daily home practice a minimum of 20 minutes on 3 non-class days each week. |
| Educational Control | Active comparator | Behavioral: Educational ControlThis arm will receive a 6-month educational control intervention. Participants will attend monthly educational group sessions within a common area of each housing facility. Sessions will be led by research personnel and include material from Patient Education Forms (PEFs) produced by the American Geriatric Society. Sessions will be semi-structured and contain approximately 30 minutes of lecture and 30 minutes of group discussion. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
- are fee-for-service Medicare Beneficiaries for the 3 study years
- Able to stand/walk independently, without the help of another person
Key exclusion criteria (5 listed)
- enrolled in a Program of All-Inclusive Care for the Elderly (PACE), or a Special Needs Plan, since this would make it difficult to isolate the effects of Tai Chi on health care utilization.
- Practice of Tai Chi for >3 years over lifetime, or more than weekly in prior 6 months
- any unstable or terminal illness (e.g., unstable cardiovascular disease, active cancer, unstable chronic obstructive pulmonary disease (COPD), advanced dementia, psychosis)
- inability to maintain posture sitting or standing
- inability to hear, see, or understand Tai Chi instructions and assessment questions.
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 training | Behavioural | Tai Chi |
| Educational Control | Behavioural | Educational Control |
Primary outcome
Change in Short Physical Performance Battery (SPPB) Total Score
Time frame: Change from baseline to 6 months
The Short Physical Performance Battery includes measures of standing balance (timing of tandem, semi-tandem, and side-by-side stands), 4-meter walking speed and the ability and time to rise from a chair 5 times. The minimum score = 0, the maximum score=12. A higher score means a better outcome.
Health Care Utilization
Time frame: up to 12 months
Health care utilization will be defined by counts of hospitalizations during the study period.
12 secondary outcomes
Mobility
Time frame: Change from baseline to 6 months
Gait Velocity
Time frame: Change from baseline to 6 months
Standing Balance
Time frame: Change from baseline to 6 months
Grip Strength
Time frame: Change from baseline to 6 months
Self-reported Physical Activity
Time frame: Change from baseline to 6 months
Executive Function
Time frame: Change from baseline to 6 months
Health-related Quality-of-life
Time frame: Change from baseline to 6 months
Depression
Time frame: Change from baseline to 6 months
Exercise Self-efficacy
Time frame: Change from baseline to 6 months
Falls
Time frame: 12 months
Health Care Utilization
Time frame: Baseline, 6 months and 12 months
Mini-Mental State Examination
Time frame: Change from baseline to 12 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 28694204Wayne PM, Gagnon MM, Macklin EA, Travison TG, Manor B, Lachman M, Thomas CP, Lipsitz LA. The Mind Body-Wellness in Supportive Housing (Mi-WiSH) study: Design and rationale of a cluster randomized controlled trial of Tai Chi in senior housing. Contemp Clin Trials. 2017 Sep;60:96-104. doi: 10.1016/j.cct.2017.07.005. Epub 2017 Jul 8.
- Results publication: PubMed 31116883Lipsitz LA, Macklin EA, Travison TG, Manor B, Gagnon P, Tsai T, Aizpurua II, Lo OY, Wayne PM. A Cluster Randomized Trial of Tai Chi vs Health Education in Subsidized Housing: The MI-WiSH Study. J Am Geriatr Soc. 2019 Sep;67(9):1812-1819. doi: 10.1111/jgs.15986. Epub 2019 May 22.
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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.
Lewis Lipsitz, MD principal investigator
Director, Marcus Institute for Aging Research, Hebrew SeniorLife
Peter Wayne, PhD principal investigator
Research Director, Osher Center, Brigham and Women's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi training in people with Aging, run by Hebrew SeniorLife 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 5 inclusion and 5 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: stopped early, as of the sponsor's last update on 21 Feb 2020. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Feb 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Short Physical Performance Battery (SPPB) Total Score (time frame: Change from baseline to 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 NCT02346136, which also lists 2 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 21 Feb 2020.