Balance Recovery Training for Fall Prevention in Retirement Communities

• Sponsor: Texas A&M University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02551666
• Collaborator: Virginia Polytechnic Institute and State University (Other), University of Michigan (Other)
• Enrollment: 35
• Arms: 2
• Actual Duration (Months): 20

Study Details

Study Description

Brief Summary

Falls are the leading cause of injuries and injury-related deaths among older adults over the age of 65 in the United States. To help reduce the number of these falls, there is growing interest in using reactive balance training to improve the reactive response to common perturbations (e.g., tripping and slipping). The goal of this study was to compare treadmill-based reactive balance training versus Tai Chi performed at, and among residents of, older adult senior housing. We hypothesized that participants randomized to reactive balance training (RBT) would show better performance on reactive balance tests compared to participants randomized to Tai Chi. We also hypothesized that participants randomized to Tai Chi would show better performance on clinical tests of balance and mobility compared to participants randomized to RBT. The long-term goal of this work is to demonstrate the value of RBT over Tai Chi for preventing falls resulting from sudden, external perturbations.

Thirty-five residents of five senior housing facilities were allocated to either treadmill-based reactive balance training or Tai Chi training. Both interventions were performed three times per week for four weeks, with each session lasting approximately 30 minutes. A battery of balance tests was performed at baseline, and again one week, one month, three months, and six months post-training. The battery included six standard clinical tests of balance and mobility, and a test of reactive balance performance.

Condition or Disease	Intervention/Treatment	Phase
Accidental Falls, Aged, Exercise Movement Techniques	Other: Balance recovery training; Other: Tai Chi exercise	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 35 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: Balance Recovery Training for Fall Prevention in Retirement Communities
• Actual Study Start Date: Sep 1, 2015
• Actual Primary Completion Date: May 1, 2017
• Actual Study Completion Date: May 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Tai Chi exercise intervention Participants will perform 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks.	Other: Tai Chi exercise; Participants will perform Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session will be led by an experienced Tai Chi instructor.
Experimental: Balance recovery training Participants will practice balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks.	Other: Balance recovery training; Participants will practice recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions will last approximately 30 minutes, and will be performed 3 times per week for 4 weeks.

Outcome Measures

Primary Outcome Measures

1. Maximum Torso Angle at 0.8 Mph [1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention]

   maximum torso angle during a simulated trip, and be measures in degrees. Larger angles indicate worse performance.

2. Maximum Torso Angle at 1.6 Mph [1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention]

   maximum torso angle during a simulated trip, and be measures in degrees. Larger angles indicate worse performance.

Secondary Outcome Measures

1. Reactive Balance Rating [1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention]

   The reactive balance rating evaluates performance in response to six separate tests on a treadmill involving sudden acceleration of the belt to elicit a loss of balance from stance. The administrator scores as 0, 1, or 2: a) the overall effectiveness of the initial stepping response to each treadmill acceleration, and b) the amount of support provided by the harness or spotter next to the participant. These scores are then combined using a rubric to determine the overall reactive balance rating. The reactive balance rating is a score on a scale from 0 to 12 where higher scores indicates a better outcome. More details are available at: Madigan ML, Aviles J, Allin LJ, Nussbaum MA, Alexander NB. A Reactive Balance Rating Method That Correlates With Kinematics After Trip-like Perturbations on a Treadmill and Fall Risk Among Residents of Older Adult Congregate Housing. The Journals of Gerontology: Series A. 2018: 73(9): 1222-1228.

2. Step Length at 0.8 Mph [1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention]

   step length during reactive balance trial.

3. Timed-up-and-go Test [1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention]

   The timed-up-and-go tests is measured in seconds. Longer times indicate worse performance.

4. Unipedal Stance Time Test [1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention]

   The unipedal stance time is measured in seconds, up to a maximum of 30 seconds. Longer times indicate better performance.

5. Maximum Step Length Test [1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention]

   Maximum step length is measured in inches. Longer maximum step length indicates better performance.

6. Activities-specific Balance Confidence (ABC) Scale [1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention]

   Activities-specific balance confidence scale ranges from 0 to 100. Larger values indicate more confidence (i.e. better outcome).

7. Performance-oriented Mobility Assessment (POMA) [1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention]

   The Performance-oriented Mobility Assessment is a common clinical test for assessing a person's static and dynamic balance abilities. The test is in two short sections that contain one examining static balance, and the other gait. The section examining static balance includes 9 individual tests scored 0, 1, or 2 by the test administrator based upon their observation of the balance performance (higher is better). The section on gait includes 7 individual tests scored 0, 1, or 2 by the test administrator based upon their observation of the gait performance (higher is better). All of these individual test scores are then summed to determine the overall Performance-oriented Mobility Assessment score. The overall Performance-oriented Mobility Assessment score is on a scale from 0 to 28. Larger values indicate better mobility. Additional details are published here: Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. JAGS 1986; 34: 119-126.

8. Berg Balance Test [1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention]

   The Berg balance test is measures that evaluates static balance and fall risk using 14 individual sub-tests. It includes static and dynamic activities of varying complexity. The test administrator scores performance on each sub-test as either a 0, 1, 2, 3, or 4. All scores are sub-tests are then summed to determine the overall Berg balance test score. The Berg balance test score is on a scale from 0 to 56. Larger values indicate better balance. More information is available at: Berg, K., Wood-Dauphine, S.L. and Williams, J.L. Measuring balance in the elderly: validation of an instrument. Can. J. Public Health, 83(S2): S7-S11, 1992.

9. Step Length at 1.6 Mph [1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention]

   step length during reactive balance trial.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 70 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• Must be age 70 or older

• Must be a resident of local continuing care retirement community (CCRC)

• Must be able to walk down a long hallway without any aids (cane, walker, etc.)

• Must not have a fragility fracture in the past 10 years

• Must not smoke

• Must not be in physical therapy

• Must not perform more than 150 minutes/week of moderate to vigorous aerobic activity

• Must score 24 or higher on Folstein Mini Mental Status Exam

• Must have less than 20% probability of major osteoporotic fracture as assessed by the fracture risk assessment tool (FRAX) score

• Must not have recently (within 1 year) participated in Tai Chi

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Texas A&M University
• Virginia Polytechnic Institute and State University
• University of Michigan

Investigators

• Principal Investigator: Michael Madigan, PhD, Virginia Polytechnic Institute and State University

Study Documents (Full-Text)

• Informed Consent Form - Oct 13, 2015
• Statistical Analysis Plan - Oct 13, 2015
• Study Protocol - Oct 13, 2015

More Information

Publications

None provided.

• Responsible Party: Michael Madigan, Professor, Biomedical Engineering, Texas A&M University
• ClinicalTrials.gov Identifier: NCT02551666
• Other Study ID Numbers: TexasAMU
• First Posted: Sep 16, 2015
• Last Update Posted: Jul 14, 2020
• Last Verified: Jun 1, 2020

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes

Study Results

Participant Flow

Pre-assignment Detail	151 prospective subjects were assessed for eligibility. 74 failed the medical screening 28 ended up declining to participate after learning more about the study 14 were withdrawn for other reasons not related to the study 35 participants remained and were allocated to one of the two treatment groups.

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Period Title: Overall Study
STARTED	16	19
COMPLETED	15	16
NOT COMPLETED	1	3

Baseline Characteristics

Arm/Group Title	Tai Chi Exercise Intervention	Balance Recovery Training	Total
Arm/Group Description	Participants will perform 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants will perform Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session will be led by an experienced Tai Chi instructor.	Participants will practice balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants will practice recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions will last approximately 30 minutes, and will be performed 3 times per week for 4 weeks.	Total of all reporting groups
Overall Participants	16	19	35
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	82.6 (4.5)	80.9 (6.2)	81.7 (5.4)
Sex: Female, Male (Count of Participants)
Female	11 68.8%	13 68.4%	24 68.6%
Male	5 31.3%	6 31.6%	11 31.4%
Race and Ethnicity Not Collected (Count of Participants)
Count of Participants [Participants]	0 0%
Region of Enrollment (participants) [Number]
United States	16 100%	19 100%	35 100%
Body mass index (kg/m^2) (kg/(m^2)) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [kg/(m^2)]	30.8 (4.5)	28.6 (5.3)	29.6 (5.0)
Number of participants reporting falls with injury in the past year (participants) [Number]
Number [participants]	5 31.3%	1 5.3%	6 17.1%
Number of participants reporting 2 or more falls in the past year (participants) [Number]
Number [participants]	5 31.3%	2 10.5%	7 20%

Outcome Measures

1. Primary Outcome

Title	Maximum Torso Angle at 0.8 Mph
Description	maximum torso angle during a simulated trip, and be measures in degrees. Larger angles indicate worse performance.
Time Frame	1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Outcome Measure Data

Analysis Population Description

participants who completed at least 9 of 12 sessions

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Measure Participants	16	19
Baseline	18.8 (9.0)	23.9 (10.6)
1 week post intervention	20.5 (8.8)	11.7 (4.4)
1 month post intervention	17.5 (7.1)	13.1 (5.7)
3 months post intervention	16.8 (3.6)	13.0 (4.1)
6 months post intervention	18.2 (7.5)	16.2 (10.5)

2. Primary Outcome

Title	Maximum Torso Angle at 1.6 Mph
Description	maximum torso angle during a simulated trip, and be measures in degrees. Larger angles indicate worse performance.
Time Frame	1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Outcome Measure Data

Analysis Population Description

participants who completed at least 9 of 12 sessions

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Measure Participants	16	19
Baseline	29.7 (14.1)	28.4 (10.4)
1 week post intervention	29.6 (12.0)	21.7 (10.8)
1 month post intervention	22.2 (6.2)	23.0 (12.3)
3 months post intervention	28.8 (7.8)	26.9 (16.5)
6 months post intervention	27.1 (12.5)	24.2 (9.8)

3. Secondary Outcome

Title	Reactive Balance Rating
Description	The reactive balance rating evaluates performance in response to six separate tests on a treadmill involving sudden acceleration of the belt to elicit a loss of balance from stance. The administrator scores as 0, 1, or 2: a) the overall effectiveness of the initial stepping response to each treadmill acceleration, and b) the amount of support provided by the harness or spotter next to the participant. These scores are then combined using a rubric to determine the overall reactive balance rating. The reactive balance rating is a score on a scale from 0 to 12 where higher scores indicates a better outcome. More details are available at: Madigan ML, Aviles J, Allin LJ, Nussbaum MA, Alexander NB. A Reactive Balance Rating Method That Correlates With Kinematics After Trip-like Perturbations on a Treadmill and Fall Risk Among Residents of Older Adult Congregate Housing. The Journals of Gerontology: Series A. 2018: 73(9): 1222-1228.
Time Frame	1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Measure Participants	16	19
Baseline	4.3 (2.0)	4.8 (3.5)
1 week after intervention	6.3 (2.4)	8.2 (3.2)
1 month after intervention	6.1 (3.3)	8.7 (3.2)
3 months after intervention	7.1 (2.4)	8.0 (3.2)
6 months after intervention	6.7 (2.2)	8.1 (3.6)

4. Secondary Outcome

Title	Step Length at 0.8 Mph
Description	step length during reactive balance trial.
Time Frame	1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Measure Participants	16	19
Baseline	.49 (.06)	.51 (.09)
1 week post intervention	.44 (.12)	.52 (.09)
1 month post intervention	.48 (.09)	.51 (.08)
3 months post intervention	.50 (.08)	.52 (.12)
6 months post intervention	.49 (.11)	.53 (.07)

5. Secondary Outcome

Title	Timed-up-and-go Test
Description	The timed-up-and-go tests is measured in seconds. Longer times indicate worse performance.
Time Frame	1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Measure Participants	16	19
Baseline	14.8 (6.0)	12.9 (4.5)
1 week post intervention	13.6 (3.9)	12.1 (3.7)
1 month post intervention	13.2 (4.2)	11.8 (3.6)
3 months post intervention	11.9 (3.4)	11.7 (3.7)
6 months post intervention	13.2 (4.7)	12.2 (4.3)

6. Secondary Outcome

Title	Unipedal Stance Time Test
Description	The unipedal stance time is measured in seconds, up to a maximum of 30 seconds. Longer times indicate better performance.
Time Frame	1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Measure Participants	16	19
Baseline	4.0 (3.2)	5.7 (6.4)
1 week post intervention	6.0 (4.9)	6.3 (7.4)
1 month post intervention	5.3 (4.5)	7.6 (10.4)
3 months post intervention	4.8 (3.7)	6.8 (9.8)
6 month post intervention	8.3 (8.7)	6.5 (9.7)

7. Secondary Outcome

Title	Maximum Step Length Test
Description	Maximum step length is measured in inches. Longer maximum step length indicates better performance.
Time Frame	1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Measure Participants	16	19
Baseline	18.1 (5.2)	20.5 (5.7)
1-week post intervention	18.9 (3.6)	21.0 (3.2)
1-month post intervention	18.9 (5.7)	22.5 (3.7)
3-month post intervention	20.7 (4.3)	20.4 (3.2)
6-month post intervention	20.8 (5.0)	20.7 (3.6)

8. Secondary Outcome

Title	Activities-specific Balance Confidence (ABC) Scale
Description	Activities-specific balance confidence scale ranges from 0 to 100. Larger values indicate more confidence (i.e. better outcome).
Time Frame	1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Measure Participants	16	19
Baseline	76.2 (16.3)	74.0 (14.1)
1-week post intervention	79.3 (15.4)	76.6 (13.8)
1-month post intervention	78.1 (13.8)	78.9 (12.0)
3-months post intervention	76.9 (13.9)	75.7 (12.9)
6-months post intervention	76.0 (17.9)	76.6 (12.0)

9. Secondary Outcome

Title	Performance-oriented Mobility Assessment (POMA)
Description	The Performance-oriented Mobility Assessment is a common clinical test for assessing a person's static and dynamic balance abilities. The test is in two short sections that contain one examining static balance, and the other gait. The section examining static balance includes 9 individual tests scored 0, 1, or 2 by the test administrator based upon their observation of the balance performance (higher is better). The section on gait includes 7 individual tests scored 0, 1, or 2 by the test administrator based upon their observation of the gait performance (higher is better). All of these individual test scores are then summed to determine the overall Performance-oriented Mobility Assessment score. The overall Performance-oriented Mobility Assessment score is on a scale from 0 to 28. Larger values indicate better mobility. Additional details are published here: Tinetti ME. Performance-oriented assessment of mobility problems in elderly patients. JAGS 1986; 34: 119-126.
Time Frame	1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Measure Participants	16	19
Baseline	23.4 (2.9)	23.7 (2.8)
1-week post intervention	24.9 (2.4)	23.9 (2.0)
1-month post intervention	24.1 (2.8)	24.9 (1.7)
3-month post intervention	24.5 (2.3)	24.9 (2.6)
6-month post intervention	23.1 (3.3)	24.3 (2.4)

10. Secondary Outcome

Title	Berg Balance Test
Description	The Berg balance test is measures that evaluates static balance and fall risk using 14 individual sub-tests. It includes static and dynamic activities of varying complexity. The test administrator scores performance on each sub-test as either a 0, 1, 2, 3, or 4. All scores are sub-tests are then summed to determine the overall Berg balance test score. The Berg balance test score is on a scale from 0 to 56. Larger values indicate better balance. More information is available at: Berg, K., Wood-Dauphine, S.L. and Williams, J.L. Measuring balance in the elderly: validation of an instrument. Can. J. Public Health, 83(S2): S7-S11, 1992.
Time Frame	1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Measure Participants	16	19
Baseline	44.5 (5.6)	47.3 (4.3)
1-week post intervention	48.0 (4.5)	48.2 (3.7)
1-month post intervention	47.7 (5.3)	49.7 (3.0)
3-month post intervention	48.7 (4.5)	49.0 (3.8)
6-month post intervention	47.7 (5.6)	49.1 (4.5)

11. Secondary Outcome

Title	Step Length at 1.6 Mph
Description	step length during reactive balance trial.
Time Frame	1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Tai Chi Exercise	Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.	Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
Measure Participants	16	19
Baseline	.61 (.10)	.56 (.11)
1 week post intervention	.56 (.10)	.62 (.09)
1 month post intervention	.58 (.06)	.60 (.09)
3 months post intervention	.64 (.03)	.62 (.07)
6 months post intervention	.63 (.05)	.61 (.09)

Adverse Events

Time Frame	Adverse event data were collected from each participant for 28 weeks. This time period spanned from the initial baseline balance assessment to six months after completing the assigned intervention.
Adverse Event Reporting Description	Definition does not differ.
Arm/Group Title	Tai Chi Exercise		Balance Recovery Training
Arm/Group Description	Participants performed 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Tai Chi exercise: Participants performed Tai Chi exercises (Yang short form) for 30 minutes, 3 times a week for 4 weeks. Each session was be led by an experienced Tai Chi instructor.		Participants performed balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. Balance recovery training: Participants practiced recovering their balance after a perturbation similar to tripping while walking. Each of these 'balance recovery training' sessions lasted approximately 30 minutes, and was performed 3 times per week for 4 weeks.
All Cause Mortality
	Tai Chi Exercise		Balance Recovery Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/19 (0%)
Serious Adverse Events
	Tai Chi Exercise		Balance Recovery Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/19 (0%)
Other (Not Including Serious) Adverse Events
	Tai Chi Exercise		Balance Recovery Training
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/16 (0%)		0/19 (0%)

Limitations/Caveats

Sample size was not sufficient to investigate falls as an outcome.

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.