Accidental Falls, Aged, Exercise Movement TechniquesNCT02551666
Balance Recovery Training for Fall Prevention in Retirement Communities
A study testing Balance recovery training and Tai Chi exercise in people with Accidental Falls, Aged, Exercise Movement Techniques, run by Texas A&M University.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and olderHealthy volunteers can take part
- Conditions the study is for
- Accidental Falls, Aged, Exercise Movement Techniques
- What is being tested?
- Balance recovery training and Tai Chi exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to May 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- 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
Show all 10Show fewer
- 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
Who cannot join
None listed.
About this study
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.
- Being tested
- Balance recovery training, Tai Chi exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Balance recovery trainingOther
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.
Tai Chi exerciseOther
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 group | Role | What they receive |
|---|---|---|
| Tai Chi exercise intervention | Active comparator | Participants will perform 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. Receives: Other: Tai Chi exercise |
| 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. Receives: Other: Balance recovery training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Torso Angle at 0.8 Mph
maximum torso angle during a simulated trip, and be measures in degrees. Larger angles indicate worse performance.
Measured: 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.
Measured: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention
Secondary outcomes (9)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2015 (estimated)
- Study startSep 2015
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Accidental Falls, Aged, Exercise Movement TechniquesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Texas A&M University
- Sponsor type
- University, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, University of Michigan
- Responsible party
- Principal investigator, Michael Madigan, Texas A&M University
- Investigators
- Michael Madigan, PhD, Principal investigator, Virginia Polytechnic Institute and State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02551666
- Sponsor's protocol ID
- TexasAMU
- Status last verified
- Jun 2020
- First submitted
- 12 Aug 2015
- Last updated
- 14 Jul 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- Yes: All outcome measures at the time points described above will be shared with other researchers.
Publications
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.
PubMed 29668910
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Balance Recovery Training for Fall Prevention in Retirement Communities
- ClinicalTrials.gov ID
- NCT02551666
- Acronym / sponsor ID
- TexasAMU
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Texas A&M UniversityUniversity, hospital or other
- Collaborators
- Virginia Polytechnic Institute and State University, University of Michigan
- Study start
- Sep 2015 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 16 Sep 2015 (estimated)
- Results
- Posted 14 Jul 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi exercise intervention | Active comparator | Other: Tai Chi exerciseParticipants will perform 30-minute Tai Chi sessions (Yang Short form) 3 times a week for 4 weeks. |
| Balance recovery training | Experimental | Other: Balance recovery trainingParticipants will practice balance recovery on a modified treadmill for approximately 30-minutes per session, 3 sessions a week for 4 weeks. |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (10 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Balance recovery trainingParticipants 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. | Other | Balance recovery training |
| Tai Chi exerciseParticipants 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. | Other | Tai Chi exercise intervention |
Primary outcome
Maximum Torso Angle at 0.8 Mph
Time frame: 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
Time frame: 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.
9 secondary outcomes
Reactive Balance Rating
Time frame: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention
Step Length at 0.8 Mph
Time frame: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention
Timed-up-and-go Test
Time frame: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention
Unipedal Stance Time Test
Time frame: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention
Maximum Step Length Test
Time frame: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention
Activities-specific Balance Confidence (ABC) Scale
Time frame: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention
Performance-oriented Mobility Assessment (POMA)
Time frame: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention
Berg Balance Test
Time frame: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention
Step Length at 1.6 Mph
Time frame: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 29668910Madigan 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.
- Individual participant dataSharing planned: Yes. All outcome measures at the time points described above will be shared with other researchers.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Madigan, PhD principal investigator
Virginia Polytechnic Institute and State University
Questions about this trial
What is this clinical trial studying?
A study testing Balance recovery training and Tai Chi exercise in people with Accidental Falls, Aged, Exercise Movement Techniques, run by Texas A&M University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 14 Jul 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Torso Angle at 0.8 Mph (time frame: 1 week, 1 month, 3 months, and 6 months after completing four weeks of exercise intervention). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02551666, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jul 2020.