Health Outcomes of Tai Chi in Subsidized Senior Housing

Study Overview
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Brief Summary
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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
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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.

Official Title
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Health Outcomes of Tai Chi in Subsidized Senior Housing

Conditions
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Aging

Intervention / Treatment
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* Behavioral: Tai Chi training
* Behavioral: Educational Control


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tai Chi<br>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. | Behavioral: Tai Chi training<br> <br> |
| Active Comparator: Educational Control<br>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. | Behavioral: Educational Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Change from baseline to 6 months | 
| Health Care Utilization | 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 | 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 | 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 | 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 | Grip strength of the dominant hand will be assessed with a hand-grip dynamometer in kilograms (kg). | 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). | 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. | 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 | 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. | 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. | 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. | 12 months | 
| Health Care Utilization | Secondary health care utilization outcomes include counts of emergency room visits. | 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. | Change from baseline to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health care utilization, Cluster randomized controlled trial, Intervention, Tai Chi, Elderly, Mobility