Trial Outcomes & Findings for Health Outcomes of Tai Chi in Subsidized Senior Housing (NCT NCT02346136)

NCT ID: NCT02346136

Last Updated: 2020-02-21

Results Overview

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.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 180 participants
• Primary outcome timeframe: Change from baseline to 6 months
• Results posted on: 2020-02-21

Participant Flow

Participant milestones

Measure	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	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
Overall Study STARTED	93	87
Overall Study COMPLETED	71	64
Overall Study NOT COMPLETED	22	23

Reasons for withdrawal

Measure	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	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
Overall Study Withdrawal by Subject	7	5
Overall Study Death	1	0
Overall Study Study termination	14	18

Baseline Characteristics

Health Outcomes of Tai Chi in Subsidized Senior Housing

Baseline characteristics by cohort

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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	Total n=180 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	9 Participants n=5 Participants	14 Participants n=7 Participants	23 Participants n=5 Participants
Age, Categorical >=65 years	84 Participants n=5 Participants	73 Participants n=7 Participants	157 Participants n=5 Participants
Age, Continuous	75.9 years STANDARD_DEVIATION 9.1 • n=5 Participants	74.6 years STANDARD_DEVIATION 8.6 • n=7 Participants	75.3 years STANDARD_DEVIATION 8.8 • n=5 Participants
Sex: Female, Male Female	63 Participants n=5 Participants	57 Participants n=7 Participants	120 Participants n=5 Participants
Sex: Female, Male Male	30 Participants n=5 Participants	30 Participants n=7 Participants	60 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	88 Participants n=5 Participants	84 Participants n=7 Participants	172 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) Asian	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	35 Participants n=5 Participants	23 Participants n=7 Participants	58 Participants n=5 Participants
Race (NIH/OMB) White	50 Participants n=5 Participants	62 Participants n=7 Participants	112 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Region of Enrollment United States	93 Participants n=5 Participants	87 Participants n=7 Participants	180 Participants n=5 Participants
Short Physical Performance Battery Total Score	7.92 units on a scale STANDARD_DEVIATION 2.76 • n=5 Participants	8.36 units on a scale STANDARD_DEVIATION 2.89 • n=7 Participants	8.14 units on a scale STANDARD_DEVIATION 2.82 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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
Change in Short Physical Performance Battery (SPPB) Total Score	0.05 units on a scale Standard Error 0.18	0.18 units on a scale Standard Error 0.19

PRIMARY outcome

Timeframe: 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).

Health care utilization will be defined by counts of hospitalizations during the study period.

Outcome measures

Measure	Tai Chi n=75 Participants 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	Educational Control n=67 Participants 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
Health Care Utilization 1 hospitalization	5 Participants	9 Participants
Health Care Utilization 2 hospitalizations	2 Participants	2 Participants
Health Care Utilization 3 hospitalizations	2 Participants	0 Participants
Health Care Utilization 0 hospitalizations	66 Participants	56 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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
Mobility	.18 seconds Standard Error .73	.83 seconds Standard Error .77

SECONDARY outcome

Timeframe: 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)

Outcome measures

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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
Gait Velocity Gait NW velocity	.01 m/s Standard Error .02	.01 m/s Standard Error .02
Gait Velocity Gait DT velocity	.02 m/s Standard Error .01	-.00 m/s Standard Error .01

SECONDARY outcome

Timeframe: Change from baseline to 6 months

Standing balance will be assessed by recording 95% ellipse sway area with eyes open in meters squared (m2)

Outcome measures

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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
Standing Balance	0.01 m^2 Standard Error 0.01	0.01 m^2 Standard Error 0.01

SECONDARY outcome

Timeframe: Change from baseline to 6 months

Grip strength of the dominant hand will be assessed with a hand-grip dynamometer in kilograms (kg).

Outcome measures

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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
Grip Strength	0.64 kg Standard Deviation 0.50	-0.17 kg Standard Deviation 0.52

SECONDARY outcome

Timeframe: 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).

Outcome measures

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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
Self-reported Physical Activity	-3.42 scores on a scale Standard Deviation 5.17	-4.14 scores on a scale Standard Deviation 5.37

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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
Executive Function	-8.19 seconds Standard Error 6.91	-9.55 seconds Standard Error 7.37

SECONDARY outcome

Timeframe: 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"

Outcome measures

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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
Health-related Quality-of-life Physical component	.22 scores on a scale Standard Error .99	-.64 scores on a scale Standard Error 1.04
Health-related Quality-of-life Mental component	-1.81 scores on a scale Standard Error 1.16	-.71 scores on a scale Standard Error 1.19

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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
Depression	-.06 score on a scale Standard Error .69	-.47 score on a scale Standard Error .74

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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
Exercise Self-efficacy	0.11 score on a scale Standard Error 1.77	-2.02 score on a scale Standard Error 1.87

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tai Chi n=77 Participants 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	Educational Control n=67 Participants 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
Falls	26 falls	16 falls

SECONDARY outcome

Timeframe: 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).

Secondary health care utilization outcomes include counts of emergency room visits.

Outcome measures

Measure	Tai Chi n=75 Participants 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	Educational Control n=67 Participants 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
Health Care Utilization 5 ED visits	1 Participants	0 Participants
Health Care Utilization 8 ED visits	0 Participants	1 Participants
Health Care Utilization 0 ED visits	55 Participants	45 Participants
Health Care Utilization 1 ED visit	15 Participants	10 Participants
Health Care Utilization 2 ED visits	4 Participants	8 Participants
Health Care Utilization 3 ED visits	0 Participants	3 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Measure	Tai Chi n=93 Participants 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	Educational Control n=87 Participants 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
Mini-Mental State Examination	0.89 score on a scale Interval -0.34 to 2.11	-0.38 score on a scale Interval -1.58 to 0.82

Adverse Events

Tai Chi

Serious events: 13 serious events

Other events: 44 other events

Deaths: 3 deaths

Educational Control

Serious events: 8 serious events

Other events: 12 other events

Deaths: 0 deaths

Serious adverse events

Measure	Tai Chi n=77 participants at risk 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	Educational Control n=67 participants at risk 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
Cardiac disorders Atrial fibrillation	0.00% 0/77 • Adverse event data was collected over 1 year	3.0% 2/67 • Number of events 2 • Adverse event data was collected over 1 year
Cardiac disorders Chest pain	1.3% 1/77 • Number of events 1 • Adverse event data was collected over 1 year	0.00% 0/67 • Adverse event data was collected over 1 year
Gastrointestinal disorders Rectal haemorrhage	1.3% 1/77 • Number of events 1 • Adverse event data was collected over 1 year	0.00% 0/67 • Adverse event data was collected over 1 year
General disorders Chest pain	0.00% 0/77 • Adverse event data was collected over 1 year	1.5% 1/67 • Number of events 1 • Adverse event data was collected over 1 year
General disorders Death	3.9% 3/77 • Number of events 3 • Adverse event data was collected over 1 year	0.00% 0/67 • Adverse event data was collected over 1 year
Injury, poisoning and procedural complications Fall	3.9% 3/77 • Number of events 4 • Adverse event data was collected over 1 year	1.5% 1/67 • Number of events 1 • Adverse event data was collected over 1 year
Injury, poisoning and procedural complications Joint injury	1.3% 1/77 • Number of events 1 • Adverse event data was collected over 1 year	0.00% 0/67 • Adverse event data was collected over 1 year
Musculoskeletal and connective tissue disorders Arthralgia	1.3% 1/77 • Number of events 1 • Adverse event data was collected over 1 year	0.00% 0/67 • Adverse event data was collected over 1 year
Musculoskeletal and connective tissue disorders Bursitis	0.00% 0/77 • Adverse event data was collected over 1 year	1.5% 1/67 • Number of events 1 • Adverse event data was collected over 1 year
Nervous system disorders Cerebral haemorrhage	1.3% 1/77 • Number of events 1 • Adverse event data was collected over 1 year	0.00% 0/67 • Adverse event data was collected over 1 year
Psychiatric disorders Depression	0.00% 0/77 • Adverse event data was collected over 1 year	1.5% 1/67 • Number of events 1 • Adverse event data was collected over 1 year
Respiratory, thoracic and mediastinal disorders Dyspnoea	2.6% 2/77 • Number of events 2 • Adverse event data was collected over 1 year	0.00% 0/67 • Adverse event data was collected over 1 year
Respiratory, thoracic and mediastinal disorders Pneumonia	0.00% 0/77 • Adverse event data was collected over 1 year	1.5% 1/67 • Number of events 2 • Adverse event data was collected over 1 year
Surgical and medical procedures Hip arthroplasty	0.00% 0/77 • Adverse event data was collected over 1 year	1.5% 1/67 • Number of events 1 • Adverse event data was collected over 1 year
Surgical and medical procedures Knee arthroplasty	1.3% 1/77 • Number of events 1 • Adverse event data was collected over 1 year	0.00% 0/67 • Adverse event data was collected over 1 year
Vascular disorders Thrombosis	1.3% 1/77 • Number of events 1 • Adverse event data was collected over 1 year	0.00% 0/67 • Adverse event data was collected over 1 year

Other adverse events

Measure	Tai Chi n=77 participants at risk 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	Educational Control n=67 participants at risk 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
Injury, poisoning and procedural complications Fall	27.3% 21/77 • Number of events 26 • Adverse event data was collected over 1 year	16.4% 11/67 • Number of events 16 • Adverse event data was collected over 1 year
Musculoskeletal and connective tissue disorders Arthralgia	6.5% 5/77 • Number of events 5 • Adverse event data was collected over 1 year	0.00% 0/67 • Adverse event data was collected over 1 year
Musculoskeletal and connective tissue disorders Musculoskeletal discomfort	23.4% 18/77 • Number of events 21 • Adverse event data was collected over 1 year	1.5% 1/67 • Number of events 1 • Adverse event data was collected over 1 year

Additional Information

Eric Macklin, PhD

MGH Biostatistics

Phone: 617-724-9828

Email: emacklin@mgh.harvard.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place