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Trial record 72 of 8113 for:    balance

Improving Balance and Mobility (MMBI)

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ClinicalTrials.gov Identifier: NCT02374463
Recruitment Status : Completed
First Posted : February 27, 2015
Last Update Posted : October 28, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Postural Balance Accidental Falls Mobility Limitation Behavioral: MMBI Behavioral: Tai Chi Not Applicable

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, 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 dual-energy X-ray absorptiometry (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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Improving Balance and Mobility in Older Veterans
Actual Study Start Date : June 1, 2015
Actual Primary Completion Date : December 31, 2018
Actual Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Falls

Arm Intervention/treatment
Experimental: MMBI
Multimodality Balance Intervention (MMBI): The Investigator's MMBI class 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.
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.

Active Comparator: 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.
Behavioral: 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.




Primary Outcome Measures :
  1. Balance and lateral mobility assessed by the four square step test [ Time Frame: 6 month ]
    Tests balance and lateral mobility, measure of fall risk


Secondary Outcome Measures :
  1. Fall rate [ Time Frame: 12 month ]
    rate of self-reported falls


Other Outcome Measures:
  1. Change in strength using Biodex [ Time Frame: 6 month ]
    Assessment of change in strength using biodex



Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02374463


Locations
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United States, Maryland
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Leslie Ira Katzel, MD PhD Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Additional Information:
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT02374463     History of Changes
Obsolete Identifiers: NCT02234817
Other Study ID Numbers: E1574-P
1I21RX001574-01A1 ( U.S. NIH Grant/Contract )
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: October 28, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by VA Office of Research and Development:
Balance
Fall Risk
Older Adults
Tai Chi
Multimodal Balance Intervention
Additional relevant MeSH terms:
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Mobility Limitation
Signs and Symptoms