- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02346136
Health Outcomes of Tai Chi in Subsidized Senior Housing (Mi-WISH)
February 20, 2020 updated by: Hebrew SeniorLife
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.
Study Overview
Status
Terminated
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
180
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Massachusetts
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Roslindale, Massachusetts, United States, 02131
- Hebrew Rehabilitation Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Tai Chi
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.
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Active Comparator: Educational Control
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Change from baseline to 6 months
|
Health Care Utilization
Time Frame: up to 12 months
|
Health care utilization will be defined by counts of hospitalizations during the study period.
|
up to 12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mobility
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
Gait Velocity
Time Frame: Change from baseline to 6 months
|
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)
|
Change from baseline to 6 months
|
Standing Balance
Time Frame: Change from baseline to 6 months
|
Standing balance will be assessed by recording 95% ellipse sway area with eyes open in meters squared (m2)
|
Change from baseline to 6 months
|
Grip Strength
Time Frame: Change from baseline to 6 months
|
Grip strength of the dominant hand will be assessed with a hand-grip dynamometer in kilograms (kg).
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Change from baseline to 6 months
|
Self-reported Physical Activity
Time Frame: Change from baseline to 6 months
|
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).
|
Change from baseline to 6 months
|
Executive Function
Time Frame: Change from baseline to 6 months
|
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. |
Change from baseline to 6 months
|
Health-related Quality-of-life
Time Frame: Change from baseline to 6 months
|
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"
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Change from baseline to 6 months
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Depression
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
|
Exercise Self-efficacy
Time Frame: Change from baseline to 6 months
|
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.
|
Change from baseline to 6 months
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Falls
Time Frame: 12 months
|
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.
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12 months
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Health Care Utilization
Time Frame: Baseline, 6 months and 12 months
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Secondary health care utilization outcomes include counts of emergency room visits.
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Baseline, 6 months and 12 months
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Mini-Mental State Examination
Time Frame: Change from baseline to 12 months
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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.
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Change from baseline to 12 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Lewis Lipsitz, MD, Director, Marcus Institute for Aging Research, Hebrew SeniorLife
- Principal Investigator: Peter Wayne, PhD, Research Director, Osher Center, Brigham and Women's Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- Lipsitz 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
January 10, 2018
Study Completion (Actual)
January 26, 2018
Study Registration Dates
First Submitted
January 20, 2015
First Submitted That Met QC Criteria
January 23, 2015
First Posted (Estimate)
January 26, 2015
Study Record Updates
Last Update Posted (Actual)
February 21, 2020
Last Update Submitted That Met QC Criteria
February 20, 2020
Last Verified
April 1, 2018
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 2R01AG025037-09A1 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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