Trial Outcomes & Findings for Fall Prevention Program for Older Adults (NCT NCT00714051)

Last Updated: 2014-10-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

55 participants

Primary outcome timeframe

4 weeks

Results posted on

2014-10-08

Participant Flow

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. .

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

Participant milestones

Participant milestones
Measure	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.	Control The control group participated in four weekly treadmill walking sessions at a self-selected speed.
Overall Study STARTED	27	28
Overall Study COMPLETED	26	27
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	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.	Control The control group participated in four weekly treadmill walking sessions at a self-selected speed.
Overall Study Withdrawal by Subject	1	0
Overall Study Death	0	1

Baseline Characteristics

Fall Prevention Program for Older Adults

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Falls Prevention Training Group n=27 Participants 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.	Control Group n=28 Participants The control group participated in four weekly treadmill walking sessions at a self-selected speed.	Total n=55 Participants Total of all reporting groups
Age, Continuous	73.0 years STANDARD_DEVIATION 4.2 • n=5 Participants	70.9 years STANDARD_DEVIATION 4.3 • n=7 Participants	71.9 years STANDARD_DEVIATION 4.3 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	2 Participants n=7 Participants	4 Participants n=5 Participants
Sex: Female, Male Male	25 Participants n=5 Participants	26 Participants n=7 Participants	51 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) White	25 Participants n=5 Participants	28 Participants n=7 Participants	53 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	27 Participants n=5 Participants	28 Participants n=7 Participants	55 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	27 participants n=5 Participants	28 participants n=7 Participants	55 participants n=5 Participants
Co-morbidities	2.6 co-morbidities STANDARD_DEVIATION 1.6 • n=5 Participants	3.1 co-morbidities STANDARD_DEVIATION 2.2 • n=7 Participants	2.9 co-morbidities STANDARD_DEVIATION 1.9 • n=5 Participants
Bone mineral density	0.94 gm/cm2 STANDARD_DEVIATION 0.1 • n=5 Participants	0.90 gm/cm2 STANDARD_DEVIATION 0.11 • n=7 Participants	0.92 gm/cm2 STANDARD_DEVIATION 0.11 • n=5 Participants
Six minute walk	546 meters STANDARD_DEVIATION 90 • n=5 Participants	545 meters STANDARD_DEVIATION 102 • n=7 Participants	545 meters STANDARD_DEVIATION 96 • n=5 Participants
Modified Falls Efficacy Scale	136.5 units on a scale STANDARD_DEVIATION 9.9 • n=5 Participants	136.3 units on a scale STANDARD_DEVIATION 10.5 • n=7 Participants	136.4 units on a scale STANDARD_DEVIATION 10.1 • n=5 Participants
Sit and reach flexibility	15.4 Centimeters STANDARD_DEVIATION 12.8 • n=5 Participants	16.2 Centimeters STANDARD_DEVIATION 9.4 • n=7 Participants	15.8 Centimeters STANDARD_DEVIATION 11.1 • n=5 Participants
Quadriceps strength	89.5 foot pounds STANDARD_DEVIATION 25.6 • n=5 Participants	89.5 foot pounds STANDARD_DEVIATION 20.4 • n=7 Participants	89.5 foot pounds STANDARD_DEVIATION 22.8 • n=5 Participants

PRIMARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Falls Prevention Training n=26 Participants 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.	Attention Control n=27 Participants The control group participated in four weekly treadmill walking sessions at a self-selected speed.
Number of Participants Who Fell on a Tripping Test	2 participants	4 participants

Adverse Events

Falls Prevention Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Attention Control

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Falls Prevention Training n=27 participants at risk 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.	Attention Control n=28 participants at risk The control group participated in four weekly treadmill walking sessions at a self-selected speed.
Cardiac disorders Death	0.00% 0/27	3.6% 1/28 • Number of events 1

Other adverse events

Adverse event data not reported

Additional Information

Eileen Collins PhD, RN

Edward Hines Jr., VA Hospital

Phone: 708-202-3525

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place