Clinical trial NCT02374463: Improving Balance and Mobility
Official title: Improving Balance and Mobility in Older Veterans
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Postural Balance
Accidental Falls
Mobility Limitation
Keywords: Balance
Fall Risk
Older Adults
Tai Chi
Multimodal Balance Intervention
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2015-02-27
Enrollment: 41
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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); 3) rate of falls; 4) lower extremity isometric strength testing (biodex); and 5) body 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 Managing Overweight and/or Obesity for Veterans Everywhere! (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.

Eligibility criteria: 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

Primary outcomes:
measure: Balance and Lateral Mobility Assessed by the Four Square Step Test
timeFrame: The FSST was assessed at 6 month (post) and at baseline (pre)
Secondary outcomes:
measure: Functional Gait Analysis
timeFrame: FGA ws measured at 6 months (post) and at baseline (pre)
measure: Change in Strength R Knee Biodex
timeFrame: Strength at the R knee was assessed at 6 months (post) and at baseline (pre)
measure: Number of Subjects Who Reported Falls
timeFrame: 6 months
measure: Change in Strength R Hip Using Biodex
timeFrame: Strength in the R hip was assessed at 6 months (post) and at baseline (pre)
Other outcomes:
measure: Percent Body Fat
timeFrame: 6 months
Locations:
city: Baltimore
country: United States
facility: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
state: Maryland
Study officials:
affiliation: Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
name: Leslie Ira Katzel, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dite W, Temple VA. A clinical test of stepping and change of direction to identify multiple falling older adults. Arch Phys Med Rehabil. 2002 Nov;83(11):1566-71. doi: 10.1053/apmr.2002.35469.
citation: Wrisley DM, Marchetti GF, Kuharsky DK, Whitney SL. Reliability, internal consistency, and validity of data obtained with the functional gait assessment. Phys Ther. 2004 Oct;84(10):906-18.