Balance Recovery Training for Fall Prevention in Retirement Communities

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02551666

Enrollment

Registered

2015-09-16

Start date

2015-09-30

Completion date

2017-05-31

Last updated

2020-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Accidental Falls, Aged, Exercise Movement Techniques

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.

Interventions

OTHERBalance 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.

OTHERTai 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

70 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
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.
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

Measure	Time frame	Description
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.
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.
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.
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.
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.
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.
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.
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).
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.

Participant flow

Pre-assignment details

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.

Participants by arm

Arm	Count
Tai Chi Exercise Intervention 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.	16
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. 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.	19
Total	35

Withdrawals & dropouts

Period	Reason	FG000	FG001
Overall Study	Withdrawal by Subject	1	3

Baseline characteristics

Characteristic	Balance Recovery Training	Total	Tai Chi Exercise Intervention
Age, Continuous	80.9 years STANDARD_DEVIATION 6.2	81.7 years STANDARD_DEVIATION 5.4	82.6 years STANDARD_DEVIATION 4.5
Body mass index (kg/m^2)	28.6 kg/(m^2) STANDARD_DEVIATION 5.3	29.6 kg/(m^2) STANDARD_DEVIATION 5	30.8 kg/(m^2) STANDARD_DEVIATION 4.5
Number of participants reporting 2 or more falls in the past year	2 participants	7 participants	5 participants
Number of participants reporting falls with injury in the past year	1 participants	6 participants	5 participants
Race and Ethnicity Not Collected	—	0 Participants	—
Region of Enrollment United States	19 participants	35 participants	16 participants
Sex: Female, Male Female	13 Participants	24 Participants	11 Participants
Sex: Female, Male Male	6 Participants	11 Participants	5 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 16	0 / 19
other Total, other adverse events	0 / 16	0 / 19
serious Total, serious adverse events	0 / 16	0 / 19

Outcome results

Primary

Maximum Torso Angle at 0.8 Mph

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