A Phase 1/2 interventional study of fall prevention training and Attention Control in Accidental Falls, sponsored by US Department of Veterans Affairs. Completed at 1 site in United States. Open to participants aged 65 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-10-08.
Sponsored by US Department of Veterans Affairs · Phase 1/2, Interventional, and Prevention
The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill.
The purpose of this study is to test the effectiveness of a fall prevention program for older adults. Participants assigned to the intervention group will train weekly on a special treadmill that will simulate tripping. Patients not assigned to the tripping program will walk on a standard treadmill. The training program will last for 4 weeks. Upon completion, participants will complete a test where a trip is simulated. Those assigned to the intervention group will test one additional time as well.
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The falls prevention training group participated in four weekly training sessions on a custom-built treadmill that produced trip-simulating perturbations (movements). While harnessed overhead to prevent actual falls, the treadmill stopped or moved suddenly. The goal for the participant was to try and prevent a fall. Each week, the level of difficulty of the task was increased.
Behavioral: fall prevention training
The attention control group participated in four weekly treadmill walking sessions at a self-selected speed.
Behavioral: Attention Control
Training on a specialized treadmill that produced trip-simulating perturbations (movements.
Participants walked on a treadmill at a self-selected speed once per week for four weeks.
Number of Participants Who Fell on a Tripping Test
Participants completed a tripping test upon completion of the 4 weeks training period. Participants walked along a platform while harnessed to an overhead rail. Participants walked at a self-selected pace knowing that they will be tripped but do not know how or when the trip will be induced. The trip is induced by an obstruction that deploys from the floor. A decoy rope was laid across the pathway about 3 meters before the trip to intentionally mislead the participant to expect the trip at that point. This expectation affects gait and response to a trip. The participant was tripped on the 3rd set of 10 walking trials.
Time frame: 4 weeks
Patients were recruited from the general medical clinics, nuclear medicine department and electronic medical record. Letters of invitation were sent to eligible participants. Recruitment began in January 2009 and ended in August 2011. .
| Milestone | Falls Prevention Training | Control |
|---|---|---|
| Started | 27 | 28 |
| Completed | 26 | 27 |
| Not completed | 1 | 1 |
| Withdrew: Withdrawal by subject | 1 | 0 |
| Withdrew: Death | 0 | 1 |
Participants completed a tripping test upon completion of the 4 weeks training period. Participants walked along a platform while harnessed to an overhead rail. Participants walked at a self-selected pace knowing that they will be tripped but do not know how or when the trip will be induced. The trip is induced by an obstruction that deploys from the floor. A decoy rope was laid across the pathway about 3 meters before the trip to intentionally mislead the participant to expect the trip at that point. This expectation affects gait and response to a trip. The participant was tripped on the 3rd set of 10 walking trials.
| participants | Falls Prevention Training | Attention Control |
|---|---|---|
| Number of Participants Who Fell on a Tripping Test | 2 | 4 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Falls Prevention Training | — | 0/27 (0%) | 0/27 (0%) |
| Attention Control | — | 1/28 (3.6%) | 0/28 (0%) |
| Event | Falls Prevention Training | Attention Control |
|---|---|---|
| DeathCardiac disorders | 0/27 | 1/28 |
| Age, Continuous(years) | Falls Prevention Training Group | Control Group | Total |
|---|---|---|---|
| Mean | 73.0 ± 4.2 | 70.9 ± 4.3 | 71.9 ± 4.3 |
| Sex: Female, Male(Participants) | Falls Prevention Training Group | Control Group | Total |
|---|---|---|---|
| Female | 2 | 2 | 4 |
| Male | 25 | 26 | 51 |
| Race (NIH/OMB)(Participants) | Falls Prevention Training Group | Control Group | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 25 | 28 | 53 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Falls Prevention Training Group | Control Group | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 27 | 28 | 55 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(participants) | Falls Prevention Training Group | Control Group | Total |
|---|---|---|---|
| United States | 27 | 28 | 55 |
| Co-morbidities(co-morbidities) | Falls Prevention Training Group | Control Group | Total |
|---|---|---|---|
| Mean | 2.6 ± 1.6 | 3.1 ± 2.2 | 2.9 ± 1.9 |
| Bone mineral density(gm/cm2) | Falls Prevention Training Group | Control Group | Total |
|---|---|---|---|
| Mean | 0.94 ± 0.1 | 0.90 ± 0.11 | 0.92 ± 0.11 |
| Six minute walk(meters) | Falls Prevention Training Group | Control Group | Total |
|---|---|---|---|
| Mean | 546 ± 90 | 545 ± 102 | 545 ± 96 |
3 further baseline measures are reported on the registry.
The record gives a start of Oct 2008, a primary completion of Feb 2012 and a completion of Oct 2014. It does not say whether these dates are actual or estimated.
Results were first posted in Oct 2014, 2 years 8 months after primary completion.
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