Improving Balance and Mobility

NCT02374463 | Completed Results DMC

• 2 other identifiers: E1574-P1I21RX001574-01A1
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Balance; Accidental Falls; Mobility Limitation

Keywords

Balance; Fall Risk; Older Adults; Tai Chi; Multimodal Balance Intervention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Functional Gait Analysis

  FGA ws measured at 6 months (post) and at baseline (pre)

• Change in Strength R Knee Biodex

  Strength at the R knee was assessed at 6 months (post) and at baseline (pre)

• Number of Subjects Who Reported Falls

  6 months

• Change in Strength R Hip Using Biodex

  Strength in the R hip was assessed at 6 months (post) and at baseline (pre)

Other Outcomes (1)

• Percent Body Fat

  6 months

Study Arms (2)

Multimodality Balance Intervention (MMBI)

EXPERIMENTAL

Multimodality Balance Intervention (MMBI)

Behavioral: MMBI

Tai Chi

ACTIVE COMPARATOR

Tai Chi Intervention

Behavioral: Tai Chi

Interventions

MMBI BEHAVIORAL

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.

Multimodality Balance Intervention (MMBI)

Tai Chi BEHAVIORAL

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.

Tai Chi

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

Related 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. doi: 10.1053/apmr.2002.35469.

  PMID: 12422327 BACKGROUND

• 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.

  PMID: 15449976 BACKGROUND

Related Links

• Exercise and Physical Fitness
• Falls

MeSH Terms

Conditions

Mobility Limitation

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Limitations and Caveats

Interpretation of the results is limited by the modest sample size.

Results Point of Contact

• Title: Leslie Katzel, MD, PhD
• Organization: Baltimore VA Medical Center

leslie.katzel@va.gov

410-605-7248

Study Officials

• Leslie Ira Katzel, MD PhD

  Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: February 27, 2015
• Study Start: June 1, 2015
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2018
• Last Updated: March 27, 2020
• Results First Posted: March 27, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)