Improving Balance and Mobility

Accidental Falls Clinical Trial

— MMBI  

Official title:

Improving Balance and Mobility in Older Veterans

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02374463
• Other study ID #: E1574-P
• Secondary ID: 1I21RX001574-01A
• Status: Completed
• Phase: N/A
• Start date: June 1, 2015
• Est. completion date: December 31, 2018

Study information

• Verified date: March 2020
• Source: VA Office of Research and Development
• Contact: n/a
• Is FDA regulated: No
• 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 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.

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.

Other known NCT identifiers

• NCT02234817

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: December 31, 2018
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Accidental Falls
• Mobility Limitation
• Postural Balance

Intervention

Behavioral:
• MMBI
Multimodality Balance Intervention (MMBI): Our MMBI will be held 3-times a week for an hour and will consist of a group dynamic balance class (30 minutes), a supervised obstacle course (10 minutes), and lower extremity and core strengthening (20 minutes). The group exercise classes will focus on dynamic weight shifts with an emphasis on the lateral and diagonal directions. Over the 6 months of class, the exercises will gradually increase in difficulty to challenge balance. A skilled instructor will lead each class and 1-2 assistants will be present to assist with fall risk prevention. The supervised obstacle course will focus on obstacle negotiation, gait over challenging surfaces, and moving in lateral, diagonal, and backward directions. Finally, strength training of the lower extremities and core will focus on strengthening major muscles of the lower extremity and core utilizing commonly available gym equipment, ankle weights and body weight.
• Tai Chi
Tai Chi Intervention: The supervised Tai Chi class will be held 3-times a week for one hour. All Tai Chi classes will be taught in a group setting by an experienced instructor. The emphasis during the class will be on standing movements, body alignment, weight shift and changes of direction. Movements will be adapted as the class progresses to increase the difficulty of weight shift and change in direction over time so that participants balance is continually challenged throughout the 6 months. Chairs or hand rails will be available for the participants to use as needed for balance recovery.

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Percent Body Fat	change in total body fat measured using Dual-energy X-ray absorptiometry (DXA). Value was calculated as value at 6 months (post) - value at baseline (pre)	6 months
Primary	Balance and Lateral Mobility Assessed by the Four Square Step Test	the Four Square Step Test assesses dynamic balance and coordination through stepping forwards, sideways, and backwards in a timed fashion. The four square step test is timed in seconds. Higher scores are associated with worse outcome. Individuals with higher scores are at increased risk of falling with some using a score of 15 seconds or higher as being at high risk for falls. The minimum value one would see in young healthy populations for this test is 5 seconds. The maximum value is 60 seconds. If they are deemed unable to complete the value is not reported	The FSST was assessed at 6 month (post) and at baseline (pre)
Secondary	Functional Gait Analysis	The Functional Gait Assessment (FGA) is designed to assess postural stability during gait. The measure is calculated by summing the scores for 10 gait related tasks. Each task is scored from 3 to 0, where 3 is the best possible performance (normal) and 0 indicates severe impairment related to the task. The best possible score is 30 and the worst possible score is 0. Higher values are associated with better outcome. A value of 22/30 and below is associated with high risk of falling in the community.	FGA ws measured at 6 months (post) and at baseline (pre)
Secondary	Change in Strength R Knee Biodex	Change in isometric strength R knee assessed using the biodex measured before and after intervention. Change was calculated as value at 6 months (post)-value at baseline (pre).Higher values are a better outcome	Strength at the R knee was assessed at 6 months (post) and at baseline (pre)
Secondary	Number of Subjects Who Reported Falls	This is the number of subjects who self-reported at least one fall, and does not include trips or near falls. This measure does not include the total number of falls as there were several participants who reported more than one fall.	6 months
Secondary	Change in Strength R Hip Using Biodex	Assessment of change in strength using biodex. Higher values are associated with better outcome	Strength in the R hip was assessed at 6 months (post) and at baseline (pre)

External Links

•   Exercise and Physical Fitness
•   Falls