Effects of a Falls Prevention Program Following Hospital Discharge



Status:Recruiting
Healthy:No
Age Range:60 - Any
Updated:1/10/2019
Start Date:November 2016
End Date:November 2020
Contact:Edgar R Vieira, PhD
Email:evieira@fiu.edu
Phone:3053480568

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Effects of a Falls Prevention Program Following Hospital Discharge From a Neuroscience Unit

A randomized, control trial will be conducted to evaluate the effects of a post-discharge
falls prevention program in patients with neurological diseases and disorders. The objective
of this study is to evaluate if implementing a falls prevention program is effective in
reducing subsequent falls and re-hospitalizations, and improving gait, strength and balance
in older adults after hospital discharge. Patients from Baptist Health Neuroscience Center
will be randomized on the day of discharge to receive an exercise falls prevention program,
delivered by Baptist Health physical therapists, or an educational pamphlet on falls
prevention. Baseline and follow up assessments for gait, balance, and strength will be
completed at regular intervals to examine effects of the exercise program. In addition,
participants will be surveyed to find out about recent falls and hospitalizations. This is a
minimal risk study such that the assessments involve conditions in which subjects likely
encounter on a daily basis. The risks of the exercise intervention also are no more than one
might expect from a community exercise program. Potential benefits include reduced
hospitalizations and/or emergency visits related to falls in the intervention group,
increased activity levels and improved falls efficacy in the intervention group, and
increased system capacity at Baptist Health to deliver a falls prevention program.

After signing the consent form, eligible participants will complete a health-related
questionnaire and undergo a gait, balance and strength testing at the time of discharge and
then be randomly referred to an intervention (n=30) or to a control group (n=30).
Participants will be recruited until the target sample (n=60) is reached. Randomization will
be by coin flip.

Measures (intervention and control groups): The evaluation involves non-invasive assessments
of physical functioning conducted by physical therapists including balance, gait, and lower
limb strength testing. Both groups will be tested by physical therapists at baseline 3, and 6
months post-discharge. A 12-month follow-up call will be made to all participants to ask
about falls and physical activity. The physical therapists that conduct the testing will be
different from the physical therapists that deliver the intervention (Otago Exercise
Program). All tests will be completed in 60-90 minute sessions at Baptist Outpatient
Rehabilitation Center. The participants will complete a questionnaire including information
on health and falls history, falls self-efficacy (Falls Efficacy Scale), hospitalizations,
doctors' visits, and emergency department visits. The participants will also complete a
physical assessment including gait analysis using an instrumented mat (GaitRite) to collect
data on the temporo-spatial parameters of gait during preferred gait speed and gait during
street crossing simulation with regular time: 7 seconds. Street crossing regular time
allowance was calculated based on the pre-programmed pedestrian street signals, which give
pedestrians 20 seconds to cross a four-lane street. The GaitRite is a thin mat with pressure
sensors; an integrated software and web-cam that measures and calculates the gait
temporo-spatial parameters. The videos are used only as a visual reference to inspect the
task for quality control during data collection and review and will not be used in the
analysis or in any other way. The physical assessment will also include the BalanceMaster
(Natus Medical, Inc.), a fixed force plate to measure the vertical forces exerted through the
feet to measure center of gravity position and postural control, Tinneti Balance Assessment,
lower limb strength testing using the 30-second chair stand test, and the Timed Up and Go
(TUG) assessment for mobility testing.

Procedures (intervention and control groups): The participants will complete the gait,
balance and chair-rise tests in random order. They will be asked a priori to wear non-slip
socks provided by the research team. During the preferred gait speed condition, the
participants will be instructed to walk on the GAITRite® at their preferred speed as they
usually do during their daily activities. During the simulated street crossing condition, the
participants will be instructed to cross the street when the pedestrian lights turn green and
complete the crossing within the time allowed as displayed by the pedestrian lights on the
video. The video includes audio of traffic noise for a more realistic road crossing
environment, and it displays an intersection situation in which the subject will be
positioned at the intersection, on the sidewalk looking at the oncoming motor vehicle traffic
from both directions. A pedestrian light with countdown will also be displayed on the screen.
Thus, a functional dual-task paradigm will be used including visual cues and the participants
will have to interpret those cues and adjust their gait accordingly. A familiarization trial
will be completed, followed by three recording trials under each condition. The order of gait
conditions will be randomized for each participant. Participants are free to stop
participating at anytime without needing to provide a reason.

Exercise Intervention (intervention group only): The intervention is a comprehensive program
addressing aging-related functional decline, fear of falling and inactivity. It targets
adults with a history of falls or at-risk for falls. Following the assessments, the
participants will be assigned to a control group who will receive the standard educational
information on falls prevention, or to an individualized exercise program prescribed and
delivered by physical therapists (Otago Exercise Program for Falls Prevention). The program
is an easy-to-implement and affordable exercise program for individuals with high risk for
falls. The program design model is person-centered and customized to the individual needs. It
includes a set of leg muscle strengthening and balance retraining exercises, and a walking
plan. Subjects will go to Baptist Outpatient Rehabilitation Center before discharge for the
baseline assessment and exercise prescription, then biweekly during the first 2 months (4
times) for exercise progressions and follow ups, once at month 3 for the first re-assessment,
then again at 6 months for a booster session and second re-assessment. At 12 months a phone
call follow up will be done to ask about falls and physical activity. The assessments and
sessions will be covered by the Baptist Health Neuroscience Center and Rehabilitation
Services. As part of the program, the participants will do 30 minutes of exercise three times
per week, and walk continuously or not for 30 minutes at least two times per week for six
months. Participants record (physical activity log) the days they exercise and walk and
provide the information to the physical therapists during subsequent visits and/or calls.

Physical therapists will prescribe the exercises based on a large selection available on the
program manual. The participants receive an illustration with explanations of the exercises
they need to do. They receive a booklet with exercise instructions and ankle cuff weights.
The physical therapists will do exercise progressions by increasing intensity and/or
difficulty during the subsequent client visits to Baptist Outpatient Rehabilitation Center.
The program also includes monthly telephone calls from study staff to maintain motivation,
collect information on any falls, and answer questions between visits.

Inclusion Criteria:

- Discharged from the hospital after being treated for a fall-related injury;

- Able to engage in an exercise program for falls prevention (sufficient physical and
cognitive health);

- Competent to provide consent.

Exclusion Criteria:

- Wheelchair bound;

- Has contraindications for engaging in an exercise program based on the patient
records;

- Does not pass the Mini Cog test (brief cognitive screening tool)

- Does not have reliable transportation for follow-up visits.
We found this trial at
1
site
Miami, Florida 33176
Principal Investigator: Edgar R Vieira, PhD
Phone: 786-596-1825
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mi
from
Miami, FL
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