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| Name | Class |
|---|---|
| University of Illinois at Chicago | OTHER |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fall Prevention Training | Experimental | 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. |
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| Attention Control | Active Comparator | The attention control group participated in four weekly treadmill walking sessions at a self-selected speed. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fall prevention training | Behavioral | Training on a specialized treadmill that produced trip-simulating perturbations (movements. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eileen G. Collins, PhD RN | Edward Hines Jr. VA Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Edward Hines, Jr. VA Hospital | Hines | Illinois | 60141-5000 | United States |
92 participants were screened for eligibility in the study. 55 participants were randomized and 37 were not randomized. Reasons for not being randomized are: 13 = bone mineral density of less than .65 gm/cm2; 11 =could not meet time commitments of study; 3=orthopedic problems; 10=other reasons
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. .
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| ID | Title | Description |
|---|---|---|
| FG000 | Falls Prevention Training | 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. |
| FG001 | Control | The control group participated in four weekly treadmill walking sessions at a self-selected speed. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Falls Prevention Training Group | 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. |
| Units | Counts |
|---|---|
| Participants |
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| 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 | 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. | Number | participants | 4 weeks |
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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 | Falls Prevention Training | 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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | Cardiac disorders | Non-systematic Assessment | Participant was found dead at home by spouse. Cause was presumed cardiac. Participant had completed baseline testing and was randomized but had not completed any control study visits. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eileen Collins PhD, RN | Edward Hines Jr., VA Hospital | 708-202-3525 | eileen.collins@va.gov |
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| Attention Control | Behavioral | Participants walked on a treadmill at a self-selected speed once per week for four weeks. |
|
| BG001 | Control Group | The control group participated in four weekly treadmill walking sessions at a self-selected speed. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Co-morbidities | Mean | Standard Deviation | co-morbidities |
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| Bone mineral density | Mean | Standard Deviation | gm/cm2 |
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| Six minute walk | Mean | Standard Deviation | meters |
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| Modified Falls Efficacy Scale | The Modified Falls Efficacy scale measures self-perceived fear of falling during the completion of 14 common activities. A score of 0=not confident at all and a score of 10=completely confident. The items are summed to form a total score. The higher score is the better score. The range of scores is 0-140. | Mean | Standard Deviation | units on a scale |
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| Sit and reach flexibility | Mean | Standard Deviation | Centimeters |
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| Quadriceps strength | Mean | Standard Deviation | foot pounds |
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| OG001 | Attention Control | The control group participated in four weekly treadmill walking sessions at a self-selected speed. |
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| 0 |
| 27 |
| 0 |
| 27 |
| EG001 | Attention Control | The control group participated in four weekly treadmill walking sessions at a self-selected speed. | 1 | 28 | 0 | 28 |
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