Improving Balance and Mobility in Older Veterans — SPIRE  

Accidental Falls Clinical Trial

Official title: Improving Balance and Mobility in Older Veterans

Status Not yet recruiting

Clinical Trial 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 the investigators new multimodal balance intervention (MMBI). MMBI focuses on standing balance, walking, stepping, strength training, and recovery from a slip. A multimodal program will most likely 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.

Clinical Trial 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 contributing. Tai Chi is currently considered to be one of the most effective fall prevention exercise interventions, with an endorsement from the CDC that 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 Individuals 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 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. ;

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor)

Related Conditions & MeSH terms

• Accidental Falls
• Distorted; Balance

• NCT number: NCT02234817
• Study type: Interventional
• Source: Baltimore VA Medical Center
• Contact: Gregory Steinbrenner, MS
• Phone: 4106057000
• Email: Gregory.Steinbrenner@va.gov
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2015
• Completion date: December 2018