Improving Balance and Mobility



Status:Active, not recruiting
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:65 - Any
Updated:12/8/2018
Start Date:June 1, 2015
End Date:December 31, 2018

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Improving Balance and Mobility in Older Veterans

Falls are dangerous leading to injuries and even death. The VA has made fall prevention a
priority, but effective programs only reduce falls by 30%. Tai Chi, a standing exercise
program, has been effective at improving balance but may not prevent falls. Most falls occur
during walking when an individual experiences a slip or a trip. Programs that focus on
walking, stepping, and recovery from a slip may be more effective at fall reduction. This
study will compare Tai Chi to a novel multimodal balance intervention (MMBI). MMBI focuses on
standing balance, walking, stepping, strength training, and recovery from a slip. The
Investigators believe that the MMBI program will be more effective than Tai Chi at improving
balance and preventing falls in older Veterans and the Investigators will use the results of
this study to develop a larger study on fall prevention in older Veterans.

Background: Falls are currently the leading cause of injurious death and non-fatal injuries
for adults over the age of 65. Older Veterans may be at greater risk for falls due to their
high burden of medical co-morbidity. The VA has made research into fall prevention a high
priority. Falls are complex with numerous deficits including impaired balance, decreased
postural control, muscle weakness, and an inability to successfully negotiate environmental
hazards. Tai Chi is currently considered to be one of the most effective fall prevention
exercise interventions, with an endorsement from the Centers for Disease Control and
Prevention (CDC) which widely influences health care policy. However, there are few studies
comparing Tai Chi with another active intervention. Tai Chi may generally improve balance,
decrease fall risk, and provides a general lower body strengthening. However, Tai Chi may not
sufficiently improve gait and dynamic mobility and does little to target obstacle
negotiation, one of the largest contributors to a fall. The majority of falls occur during
walking, with slips and trips being the most common causes and targeted interventions focused
on improving stepping and walking ability may be even more effective at improving balance and
reducing falls.

The Investigators plan to enroll 56 older (age > 65 years) community dwelling Veterans with a
history of a fall in the last year who are at high risk for a recurrent fall. After baseline
testing participants will be randomized to either MMBI or a Tai Chi intervention modeled
after the Tai Chi Moving for Better Balance Program. All participants will participate in a
group exercise class in their assigned intervention for 1 hour, 3 times per week for 24
weeks. After the completion of 24 weeks of exercise group changes will be compared for 1)
balance (4-square step test), 2) mobility and fall risk (functional gait assessment, clinical
gait assessment and gait variability on a GAITrite), 4) questionnaires (falls efficacy and
ABC) 5) lower extremity isometric strength testing (biodex), 6) a whole body dual-energy
X-ray absorptiometry (DXA) and CT scan of the abdomen, hips and thighs for determination of
lower extremity and core muscle composition. The investigators also plan for follow all
participants for 6 months after completion of the intervention to examine differences in fall
rates after the cessation of the program between the groups.

Impact: This research directly benefits Veterans as it may lead to new and effective
interventions that could reduce fall risk, injury-related hospitalization and death in older
Veterans. MMBI is also readily exportable to the community and with minimal resources could
be widely implemented at other VAs as part of standard of care, similar to MOVE!. Results
from this SPIRE grant will be used to power a larger randomized clinical trial that will
examine the effectiveness of the two interventions to reduce rate of falls and risk of
falling in older Veterans at high risk for falls.

Inclusion Criteria:

- 65 years of age and older

- Mobility and balance limitations as demonstrated by a self-reported fall within the
past year or requiring greater than 8 seconds to complete the 4-square step test

Exclusion Criteria:

- Cardiovascular Risks: Poorly controlled hypertension (>160/100); Class III or IV
congestive heart failure (CHF); or patient report of: symptomatic angina at rest or
during exercise, syncope without known resolution of cause, or a significant coronary
event (such as a MI) in the past six months

- Chronic obstructive pulmonary disease (COPD) requiring home oxygen

- Contraindications to resistance training, including a self-reported history of
intracranial or retinal bleeding in the last year or Diabetes with active
proliferative retinopathy

- Patient report of significant spinal stenosis that would limit participation in the
exercise intervention -Dementia (on medical record review or mini-mental status exam
score <24).

- Non-ambulatory mobility status or a transtibial or transfemoral amputation

- Other severe medical illness or condition that would preclude safe participation in
the study as determined by the study team
We found this trial at
1
site
Baltimore, Maryland 21201
Principal Investigator: Leslie Ira Katzel, MD PhD
Phone: (410) 605-7248
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from
Baltimore, MD
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