Improving Balance and Mobility in Older Veterans

Accidental Falls Clinical Trial

— SPIRE  

Official title:

Improving Balance and Mobility in Older Veterans

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02234817
• Other study ID #: 1I21RX001574-01A1
• Status: Not yet recruiting
• Phase: N/A
• First received: September 5, 2014
• Last updated: September 8, 2014
• Start date: January 2015
• Est. completion date: December 2018

Study information

• Verified date: September 2014
• Source: Baltimore VA Medical Center
• Contact: Gregory Steinbrenner, MS
• Phone: 4106057000
• Email: Gregory.Steinbrenner[@]va.gov
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 56
• Est. completion date: December 2018
• Est. primary completion date: December 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

Inclusion Criteria:

• Veterans

• 65 years of age and older

• History of fall in past year or fear of falling

• Balance dysfunction as indexed by four square step test (FSST) >10 sec

Exclusion Criteria:

• Poorly controlled hypertension (>160/100); Coronary event in past 6 months; Class III or IV CHF; symptomatic angina at rest or during exercise; Syncope in past year, without known resolution of cause;

• COPD requiring home oxygen Contraindications to resistance training, including:

history of intracranial or retinal bleeding; Diabetes with active proliferative retinopathy

• History of significant spinal osteoarthritis or spinal stenosis.

• Dementia (on medical record review or mini-mental status exam score <24).

• Conditions limiting response to strength or balance training, such as :severe vestibular disorders, prior stroke with residual weakness or other progressive neurologic disorders (e.g. Parkinson's disease, myasthenia gravis);Non-ambulatory; Prosthetic joint in prior year; transtibial or above the knee amputation

• Other severe medical illness, examples include: chemotherapy or radiation therapy for active cancer; diabetes with HgbA1c > 10; chronic wounds on legs; thrombocytopenia; peripheral vascular disease with claudication limiting the ability to walk; anemia with HCT <30%.

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

Intervention

Other:
• Tai Chi
Tai Chi 3 times per week for 6 months
• Multi modal exercise
center-based exercise three times per week for 6 months

Locations

Country	Name	City	State
United States	Baltimore VAMC	Baltimore	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Baltimore VA Medical Center	VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	strength	Assessment of change in strength using biodex	6 month	No
Primary	Four square step test	Tests balance and lateral mobility, measure of fall risk	6 month	Yes
Secondary	Fall rate	rate of self-reported falls	12 month	Yes