Accidental Falls, Aged, Exercise Movement Techniques Clinical Trial
Official title:
Balance Recovery Training for Fall Prevention in Retirement Communities
| NCT number | NCT02551666 |
| Other study ID # | TexasAMU |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | |
| Last updated | |
| Start date | September 2015 |
| Est. completion date | May 2017 |
| Verified date | June 2020 |
| Source | Texas A&M University |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 35 |
| Est. completion date | May 2017 |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | 70 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Texas A&M University | University of Michigan, Virginia Polytechnic Institute and State University |
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. J Gerontol A Biol Sci — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention | |
| Primary | Maximum Torso Angle at 1.6 Mph | maximum torso angle during a simulated trip, and be measures in degrees. Larger angles indicate worse performance. | 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention | |
| Secondary | Reactive Balance Rating | 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. |
1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention | |
| Secondary | Step Length at 0.8 Mph | step length during reactive balance trial. | 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention | |
| Secondary | Timed-up-and-go Test | The timed-up-and-go tests is measured in seconds. Longer times indicate worse performance. | 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention | |
| Secondary | Unipedal Stance Time Test | The unipedal stance time is measured in seconds, up to a maximum of 30 seconds. Longer times indicate better performance. | 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention | |
| Secondary | Maximum Step Length Test | Maximum step length is measured in inches. Longer maximum step length indicates better performance. | 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention | |
| Secondary | Activities-specific Balance Confidence (ABC) Scale | Activities-specific balance confidence scale ranges from 0 to 100. Larger values indicate more confidence (i.e. better outcome). | 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention | |
| Secondary | Performance-oriented Mobility Assessment (POMA) | 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. |
1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention | |
| Secondary | Berg Balance Test | 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. |
1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention | |
| Secondary | Step Length at 1.6 Mph | step length during reactive balance trial. | 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention |