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| Name | Class |
|---|---|
| Virginia Polytechnic Institute and State University | OTHER |
| University of Michigan | OTHER |
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tai Chi exercise intervention | Active Comparator | Participants will perform 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. |
|
| Balance recovery training | Experimental | Participants will practice balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balance recovery training | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael Madigan, PhD | Virginia Polytechnic Institute and State University | Principal Investigator |
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| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29668910 | Result | 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 Med Sci. 2018 Aug 10;73(9):1222-1228. doi: 10.1093/gerona/gly077. |
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All outcome measures at the time points described above will be shared with other researchers.
These data will be made available starting one year after publication.
Access will be provided for supplementary analyses. IPD will be shared via email.
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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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tai Chi Exercise | 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. |
| FG001 | Balance Recovery Training | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | participants who completed at least 9 of 12 sessions | Posted | Mean | Standard Deviation | degrees | 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention |
|
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.
Definition does not differ.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tai Chi Exercise | 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. |
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Sample size was not sufficient to investigate falls as an outcome.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Professor Michael L. Madigan, PhD | Virginia Tech | 540-231-3543 | mlm@vt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 13, 2015 | Jun 29, 2020 | ICF_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 13, 2015 | Jun 29, 2020 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Oct 13, 2015 | Jun 29, 2020 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D000088543 | Aquatic Therapy |
| ID | Term |
|---|---|
| D006875 | Hydrotherapy |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Tai Chi exercise | Other | 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. |
|
| 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Body mass index (kg/m^2) | Mean | Standard Deviation | kg/(m^2) |
|
| Number of participants reporting falls with injury in the past year | Number | participants |
|
| Number of participants reporting 2 or more falls in the past year | Number | participants |
|
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.
|
|
| 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. | participants who completed at least 9 of 12 sessions | Posted | Mean | Standard Deviation | degrees | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | meters | 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. | Posted | Mean | Standard Deviation | seconds | 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. | Posted | Mean | Standard Deviation | seconds | 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. | Posted | Mean | Standard Deviation | inches | 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). | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | score on a scale | 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. | Posted | Mean | Standard Deviation | meters | 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention |
|
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| 0 |
| 16 |
| 0 |
| 16 |
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| 16 |
| EG001 | Balance Recovery Training | 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. | 0 | 19 | 0 | 19 | 0 | 19 |
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