Aging
Conditions
Keywords
Tai Chi, Cluster randomized controlled trial, Intervention, Elderly, Mobility, Health care utilization
Brief 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. 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.
Interventions
BEHAVIORALTai Chi training
BEHAVIORALEducational Control
Sponsors
Brigham and Women's Hospital
Brandeis University
Massachusetts General Hospital
University of Massachusetts, Boston
Hebrew SeniorLife
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Short Physical Performance Battery (SPPB) Total Score | 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 | up to 12 months | Health care utilization will be defined by counts of hospitalizations during the study period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Standing Balance | Change from baseline to 6 months | Standing balance will be assessed by recording 95% ellipse sway area with eyes open in meters squared (m2) |
| Grip Strength | Change from baseline to 6 months | Grip strength of the dominant hand will be assessed with a hand-grip dynamometer in kilograms (kg). |
| Self-reported Physical Activity | 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). |
| Executive Function | 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. |
| Health-related Quality-of-life | 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 |
| Mobility | 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. |
| Exercise Self-efficacy | 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. |
| Falls | 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. |
| Health Care Utilization | Baseline, 6 months and 12 months | Secondary health care utilization outcomes include counts of emergency room visits. |
| Mini-Mental State Examination | Change from baseline to 12 months | 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. |
| Depression | 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. |
| Gait Velocity | 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) |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 93 |
| 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 | 87 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 0 |
| Overall Study | Study termination | 14 | 18 |
| Overall Study | Withdrawal by Subject | 7 | 5 |
Baseline characteristics
| Characteristic | Tai Chi | Educational Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 84 Participants | 73 Participants | 157 Participants |
| Age, Categorical Between 18 and 65 years | 9 Participants | 14 Participants | 23 Participants |
| Age, Continuous | 75.9 years STANDARD_DEVIATION 9.1 | 74.6 years STANDARD_DEVIATION 8.6 | 75.3 years STANDARD_DEVIATION 8.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 3 Participants | 8 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 88 Participants | 84 Participants | 172 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) Asian | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants | 23 Participants | 58 Participants |
| Race (NIH/OMB) More than one race | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 0 Participants | 2 Participants |
| Race (NIH/OMB) White | 50 Participants | 62 Participants | 112 Participants |
| Region of Enrollment United States | 93 Participants | 87 Participants | 180 Participants |
| Sex: Female, Male Female | 63 Participants | 57 Participants | 120 Participants |
| Sex: Female, Male Male | 30 Participants | 30 Participants | 60 Participants |
| Short Physical Performance Battery Total Score | 7.92 units on a scale STANDARD_DEVIATION 2.76 | 8.36 units on a scale STANDARD_DEVIATION 2.89 | 8.14 units on a scale STANDARD_DEVIATION 2.82 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 77 | 0 / 67 |
| other Total, other adverse events | 44 / 77 | 12 / 67 |
| serious Total, serious adverse events | 13 / 77 | 8 / 67 |
Outcome results
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.
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi | Change in Short Physical Performance Battery (SPPB) Total Score | 0.05 units on a scale | Standard Error 0.18 |
| Educational Control | Change in Short Physical Performance Battery (SPPB) Total Score | 0.18 units on a scale | Standard Error 0.19 |
p-value: 0.6295% CI: [-0.62, 0.37]Mixed Models Analysis
Primary
Health Care Utilization
Health care utilization will be defined by counts of hospitalizations during the study period.
Time frame: up to 12 months
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tai Chi | Health Care Utilization | 0 hospitalizations | 66 Participants |
| Tai Chi | Health Care Utilization | 2 hospitalizations | 2 Participants |
| Tai Chi | Health Care Utilization | 3 hospitalizations | 2 Participants |
| Tai Chi | Health Care Utilization | 1 hospitalization | 5 Participants |
| Educational Control | Health Care Utilization | 3 hospitalizations | 0 Participants |
| Educational Control | Health Care Utilization | 0 hospitalizations | 56 Participants |
| Educational Control | Health Care Utilization | 1 hospitalization | 9 Participants |
| Educational Control | Health Care Utilization | 2 hospitalizations | 2 Participants |
p-value: 0.19495% CI: [0.182, 1.57]Mixed Models Analysis
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.
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi | Depression | -.06 score on a scale | Standard Error 0.69 |
| Educational Control | Depression | -.47 score on a scale | Standard Error 0.74 |
p-value: 0.6995% CI: [-1.6, 2.41]Mixed Models Analysis
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.
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi | Executive Function | -8.19 seconds | Standard Error 6.91 |
| Educational Control | Executive Function | -9.55 seconds | Standard Error 7.37 |
p-value: 0.8895% CI: [-17.2, 19.9]Mixed Models Analysis
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.
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi | Exercise Self-efficacy | 0.11 score on a scale | Standard Error 1.77 |
| Educational Control | Exercise Self-efficacy | -2.02 score on a scale | Standard Error 1.87 |
p-value: 0.4195% CI: [-2.98, 7.26]Mixed Models Analysis
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.
Time frame: 12 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Tai Chi | Falls | 26 falls |
| Educational Control | Falls | 16 falls |
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)
Time frame: Change from baseline to 6 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tai Chi | Gait Velocity | Gait NW velocity | .01 m/s | Standard Error 0.02 |
| Tai Chi | Gait Velocity | Gait DT velocity | .02 m/s | Standard Error 0.01 |
| Educational Control | Gait Velocity | Gait NW velocity | .01 m/s | Standard Error 0.02 |
| Educational Control | Gait Velocity | Gait DT velocity | -.00 m/s | Standard Error 0.01 |
Comparison: Gait NW velocity variablep-value: 0.8595% CI: [-0.04, 0.05]Mixed Models Analysis
Comparison: Gait DT velocity variablep-value: 0.2695% CI: [-0.02, 0.06]Mixed Models Analysis
Secondary
Grip Strength
Grip strength of the dominant hand will be assessed with a hand-grip dynamometer in kilograms (kg).
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi | Grip Strength | 0.64 kg | Standard Deviation 0.5 |
| Educational Control | Grip Strength | -0.17 kg | Standard Deviation 0.52 |
p-value: 0.2695% CI: [-0.61, 2.22]Mixed Models Analysis
Secondary
Health Care Utilization
Secondary health care utilization outcomes include counts of emergency room visits.
Time frame: Baseline, 6 months and 12 months
Population: 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).
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Tai Chi | Health Care Utilization | 5 ED visits | 1 Participants |
| Tai Chi | Health Care Utilization | 0 ED visits | 55 Participants |
| Tai Chi | Health Care Utilization | 1 ED visit | 15 Participants |
| Tai Chi | Health Care Utilization | 2 ED visits | 4 Participants |
| Tai Chi | Health Care Utilization | 3 ED visits | 0 Participants |
| Tai Chi | Health Care Utilization | 8 ED visits | 0 Participants |
| Educational Control | Health Care Utilization | 5 ED visits | 0 Participants |
| Educational Control | Health Care Utilization | 3 ED visits | 3 Participants |
| Educational Control | Health Care Utilization | 2 ED visits | 8 Participants |
| Educational Control | Health Care Utilization | 0 ED visits | 45 Participants |
| Educational Control | Health Care Utilization | 8 ED visits | 1 Participants |
| Educational Control | Health Care Utilization | 1 ED visit | 10 Participants |
p-value: 0.0695% CI: [0.216, 1.05]Mixed Models Analysis
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
Time frame: Change from baseline to 6 months
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Tai Chi | Health-related Quality-of-life | Physical component | .22 scores on a scale | Standard Error 0.99 |
| Tai Chi | Health-related Quality-of-life | Mental component | -1.81 scores on a scale | Standard Error 1.16 |
| Educational Control | Health-related Quality-of-life | Physical component | -.64 scores on a scale | Standard Error 1.04 |
| Educational Control | Health-related Quality-of-life | Mental component | -.71 scores on a scale | Standard Error 1.19 |
Comparison: Physical component scorep-value: 0.5595% CI: [-2, 3.71]Mixed Models Analysis
Comparison: Mental component scorep-value: 0.5195% CI: [-4.41, 2.21]Mixed Models Analysis
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.
Time frame: Change from baseline to 12 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) |
|---|---|---|
| Tai Chi | Mini-Mental State Examination | 0.89 score on a scale |
| Educational Control | Mini-Mental State Examination | -0.38 score on a scale |
p-value: 0.1395% CI: [-0.4, 2.94]Mixed Models Analysis
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.
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi | Mobility | .18 seconds | Standard Error 0.73 |
| Educational Control | Mobility | .83 seconds | Standard Error 0.77 |
p-value: 0.595% CI: [-2.53, 1.24]Mixed Models Analysis
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).
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi | Self-reported Physical Activity | -3.42 scores on a scale | Standard Deviation 5.17 |
| Educational Control | Self-reported Physical Activity | -4.14 scores on a scale | Standard Deviation 5.37 |
p-value: 0.9295% CI: [-13.9, 15.3]Mixed Models Analysis
Secondary
Standing Balance
Standing balance will be assessed by recording 95% ellipse sway area with eyes open in meters squared (m2)
Time frame: Change from baseline to 6 months
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Tai Chi | Standing Balance | 0.01 m^2 | Standard Error 0.01 |
| Educational Control | Standing Balance | 0.01 m^2 | Standard Error 0.01 |
p-value: 0.8495% CI: [-0.04, 0.03]Mixed Models Analysis