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| Name | Class |
|---|---|
| Brigham and Women's Hospital | OTHER |
| Brandeis University | OTHER |
| Massachusetts General Hospital | OTHER |
| University of Massachusetts, Boston |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tai Chi training | Behavioral |
| ||
| Educational Control |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hebrew Rehabilitation Center | Roslindale | Massachusetts | 02131 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28694204 | Background | 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. | |
| 31116883 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. Tai Chi training |
| FG001 | 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. Educational Control |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 DVDs (and DVD players if necessary) and instructions for daily home practice a minimum of 20 minutes on 3 non-class days each week. Tai Chi training |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Least Squares Mean | Standard Error | units on a scale | Change from baseline to 6 months |
|
Adverse event data was collected over 1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 DVDs (and DVD players if necessary) and instructions for daily home practice a minimum of 20 minutes on 3 non-class days each week. Tai Chi training |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Atrial fibrillation | Cardiac disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eric Macklin, PhD | MGH Biostatistics | 617-724-9828 | emacklin@mgh.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 27, 2017 | Oct 14, 2019 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010342 | Patient Acceptance of Health Care |
| ID | Term |
|---|---|
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |
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| OTHER |
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|
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 |
| Study termination |
|
| BG001 | 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. Educational Control |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Short Physical Performance Battery 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. | Mean | Standard Deviation | units on a scale |
|
| OG001 | 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. Educational Control |
|
|
|
| Primary | Health Care Utilization | Health care utilization will be defined by counts of hospitalizations during the study period. | The 142 participants analyzed for health care utilization measures were those enrolled at sites that initiated assigned treatment (excluding 32 participants), had not withdrawn prior to treatment initiation (excludes 4 participants), and for whom at least one assessment of health care utilization was completed (excludes 2 participants). | Posted | Count of Participants | Participants | up to 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | seconds | Change from baseline to 6 months |
|
|
|
|
| Secondary | 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) | Posted | Least Squares Mean | Standard Error | m/s | Change from baseline to 6 months |
|
|
|
|
| Secondary | Standing Balance | Standing balance will be assessed by recording 95% ellipse sway area with eyes open in meters squared (m2) | Posted | Least Squares Mean | Standard Error | m^2 | Change from baseline to 6 months |
|
|
|
|
| Secondary | Grip Strength | Grip strength of the dominant hand will be assessed with a hand-grip dynamometer in kilograms (kg). | Posted | Mean | Standard Deviation | kg | Change from baseline to 6 months |
|
|
|
|
| Secondary | 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). | Posted | Mean | Standard Deviation | scores on a scale | Change from baseline to 6 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | seconds | Change from baseline to 6 months |
|
|
|
|
| Secondary | 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" | Posted | Least Squares Mean | Standard Error | scores on a scale | Change from baseline to 6 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Change from baseline to 6 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | Standard Error | score on a scale | Change from baseline to 6 months |
|
|
|
|
| Secondary | 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. | Posted | Number | falls | 12 months |
|
|
|
| Secondary | Health Care Utilization | Secondary health care utilization outcomes include counts of emergency room visits. | The 142 participants analyzed for health care utilization measures were those enrolled at sites that initiated assigned treatment (excluding 32 participants), had not withdrawn prior to treatment initiation (excludes 4 participants), and for whom at least one assessment of health care utilization was completed (excludes 2 participants). | Posted | Count of Participants | Participants | Baseline, 6 months and 12 months |
|
|
|
|
| Secondary | 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. | Posted | Least Squares Mean | 95% Confidence Interval | score on a scale | Change from baseline to 12 months |
|
|
|
|
| 3 |
| 77 |
| 13 |
| 77 |
| 44 |
| 77 |
| EG001 | 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. Educational Control | 0 | 67 | 8 | 67 | 12 | 67 |
| Chest pain | Cardiac disorders | Systematic Assessment |
|
| Rectal haemorrhage | Gastrointestinal disorders | Systematic Assessment |
|
| Chest pain | General disorders | Systematic Assessment |
|
| Death | General disorders | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Joint injury | Injury, poisoning and procedural complications | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Bursitis | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cerebral haemorrhage | Nervous system disorders | Systematic Assessment |
|
| Depression | Psychiatric disorders | Systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Hip arthroplasty | Surgical and medical procedures | Systematic Assessment |
|
| Knee arthroplasty | Surgical and medical procedures | Systematic Assessment |
|
| Thrombosis | Vascular disorders | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Musculoskeletal discomfort | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
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| 2 hospitalizations |
|
| 3 hospitalizations |
|
| Mixed Models Analysis |
| .26 |
| Mean Difference (Net) |
| .02 |
| Standard Error of the Mean |
| .02 |
| 2-Sided |
| 95 |
| -.02 |
| .06 |
| Superiority |
| Mixed Models Analysis |
| .51 |
| Mean Difference (Net) |
| -1.10 |
| Standard Error of the Mean |
| 1.66 |
| 2-Sided |
| 95 |
| -4.41 |
| 2.21 |
| Superiority |
| 2 ED visits |
|
| 3 ED visits |
|
| 5 ED visits |
|
| 8 ED visits |
|