Accidental Falls
Conditions
Brief summary
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.
Detailed description
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.
Interventions
BEHAVIORALfall prevention training
Training on a specialized treadmill that produced trip-simulating perturbations (movements.
BEHAVIORALAttention Control
Participants walked on a treadmill at a self-selected speed once per week for four weeks.
Sponsors
University of Illinois at Chicago
US Department of Veterans Affairs
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
65 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* 65-80 yr old, * normal reflexes and muscle tone
Exclusion criteria
* lower extremity fracture or surgery last 5 yrs * back surgery or disc herniation last 5 yrs * noticeable gait impairment, * low back pain, * decreased disease-related vision, * dizziness, * history of heart problems, * bone mineral density \<.65, * mini-mental score \<24
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Fell on a Tripping Test | 4 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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. .
Pre-assignment details
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
Participants by arm
| Arm | Count |
|---|---|
| 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. | 27 |
| Control Group The control group participated in four weekly treadmill walking sessions at a self-selected speed. | 28 |
| Total | 55 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 0 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Control Group | Total | Falls Prevention Training Group |
|---|---|---|---|
| Age, Continuous | 70.9 years STANDARD_DEVIATION 4.3 | 71.9 years STANDARD_DEVIATION 4.3 | 73.0 years STANDARD_DEVIATION 4.2 |
| Bone mineral density | 0.90 gm/cm2 STANDARD_DEVIATION 0.11 | 0.92 gm/cm2 STANDARD_DEVIATION 0.11 | 0.94 gm/cm2 STANDARD_DEVIATION 0.1 |
| Co-morbidities | 3.1 co-morbidities STANDARD_DEVIATION 2.2 | 2.9 co-morbidities STANDARD_DEVIATION 1.9 | 2.6 co-morbidities STANDARD_DEVIATION 1.6 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 28 Participants | 55 Participants | 27 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Modified Falls Efficacy Scale | 136.3 units on a scale STANDARD_DEVIATION 10.5 | 136.4 units on a scale STANDARD_DEVIATION 10.1 | 136.5 units on a scale STANDARD_DEVIATION 9.9 |
| Quadriceps strength | 89.5 foot pounds STANDARD_DEVIATION 20.4 | 89.5 foot pounds STANDARD_DEVIATION 22.8 | 89.5 foot pounds STANDARD_DEVIATION 25.6 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 53 Participants | 25 Participants |
| Region of Enrollment United States | 28 participants | 55 participants | 27 participants |
| Sex: Female, Male Female | 2 Participants | 4 Participants | 2 Participants |
| Sex: Female, Male Male | 26 Participants | 51 Participants | 25 Participants |
| Sit and reach flexibility | 16.2 Centimeters STANDARD_DEVIATION 9.4 | 15.8 Centimeters STANDARD_DEVIATION 11.1 | 15.4 Centimeters STANDARD_DEVIATION 12.8 |
| Six minute walk | 545 meters STANDARD_DEVIATION 102 | 545 meters STANDARD_DEVIATION 96 | 546 meters STANDARD_DEVIATION 90 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 27 | 0 / 28 |
| serious Total, serious adverse events | 0 / 27 | 1 / 28 |
Outcome results
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.
Time frame: 4 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Falls Prevention Training | Number of Participants Who Fell on a Tripping Test | 2 participants |
| Attention Control | Number of Participants Who Fell on a Tripping Test | 4 participants |
Comparison: The number of participants who fell on the tripping trial in each group were compared using Chi-square analysisp-value: 0.45Chi-squared