Balance Intervention for Falling

(Virtual MMBI Trial)

Overseen By Jeffrey P Beans, BS

Age: 65+

Sex: Any

Trial Phase: Academic

Sponsor: VA Office of Research and Development

Disqualifiers: Hypertension, Home oxygen, Cognitive impairment, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if adding a special home-based balance exercise, known as the Multimodal Balance Intervention, can better prevent falls in older Veterans compared to a standard wellness program called Gerofit. The exercise focuses on strengthening the hip muscles, which are crucial for balance. The study will compare two groups: one performing the new balance exercises before joining Gerofit, and the other joining Gerofit directly. Veterans aged 65 or older, who receive care through the VA Maryland Health Care System and are at risk of falling, might be suitable candidates for this trial. As an unphased trial, it offers Veterans the chance to contribute to innovative research that could improve fall prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this exercise intervention is safe for older Veterans?

Research has shown that programs combining balance and strength exercises are generally safe and well-tolerated. In these studies, participants experienced fewer falls, with some reporting a 17% reduction in fall incidents. No major negative effects resulted from the exercises, indicating safety for participants.

This trial includes a program called Gerofit, a virtual wellness program featuring warm-ups, aerobic exercises (beneficial for heart and lung health), and general strength training. Although specific safety data for Gerofit isn't provided, it is considered a best practice program for veterans, having been used safely in similar situations.

Overall, evidence from previous studies suggests that both the balance and strength exercises and Gerofit are likely safe options for reducing falls. Participants can feel confident about the safety of these treatments based on the available data. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Balance Intervention for Falling because it combines a virtual multi-modality balance program targeting hip abductors with the established Gerofit wellness program. Unlike traditional balance training, which often involves in-person sessions, this intervention leverages virtual formats, making it accessible and convenient for participants. This approach not only enhances balance through targeted exercises but also integrates general fitness and strength training over a longer period, potentially offering more comprehensive benefits for fall prevention.

What evidence suggests that this trial's treatments could be effective for fall risk reduction?

Research has shown that exercise programs focusing on balance and strength can greatly lower the risk of falls. Exercises involving sudden movements to improve balance recovery have enhanced stability and reduced falls in some groups. In this trial, participants may receive the Multimodal Balance Intervention (MMBI) combined with Gerofit, a virtual wellness program. Programs that combine different types of physical activities have improved balance, strength, and overall function in adults, thereby lowering their risk of falling. One study found this type of exercise program as effective as other specialized programs in reducing falls. This suggests that exercises focused on balance can effectively reduce fall risks in older adults. ^{1 4 6 7 8}

Who Is on the Research Team?

Odessa R. Addison, PhD DPT

Principal Investigator

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

Are You a Good Fit for This Trial?

This trial is for older veterans at risk of falling. Participants should be able to engage in exercises aimed at improving balance by strengthening hip muscles. The study will evaluate if a virtual multimodal balance intervention before joining the Gerofit program offers greater benefits in reducing fall risks and enhancing muscle and mobility function.

Inclusion Criteria

VA primary Care provider

Enrolled in the VA Maryland Health Care System for health care

I am at risk for falling.

Exclusion Criteria

Home oxygen use

My high blood pressure is not well-managed.

Significant cognitive impairment

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants engage in a virtual multi-modality balance intervention targeting hip abductors for 3 months

12 weeks

Virtual sessions

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Extension

Participants continue with 9 months of virtual Gerofit program

9 months

What Are the Treatments Tested in This Trial?

Interventions

• Multimodal Balance Intervention

Trial Overview The study tests whether a live, home-based exercise program targeting hip abductors can reduce falls when done before starting the Gerofit health promotion program. It compares the effectiveness of this pre-Gerofit intervention with just participating in Gerofit alone.

How Is the Trial Designed?

Group I: MMBI + Gerofit Experimental Treatment 2 Interventions

Participation in a virtual multi-modality balance intervention that targets the hip abductors for 3-months followed by 9 months participation in virtual Gerofit

Group II: Gerofit Active Control 1 Intervention

Participation in a virtual wellness program that consists of a warm up, aerobic training, and general strength training

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10435089/

Effectiveness of exercise interventions on fall prevention in ... Perturbation-based balance exercises showed improvement in local dynamic stability and balance recovery with effects lasting for a week after the intervention, ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT02234817

Study Details | NCT02234817 | Improving Balance and Mobility 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%.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40153408/

Multimodal Exercise Program of Balance and Strength ... The program significantly improved balance, functionality, fall risk, and strength in adults with haemophilia, potentially enhancing mobility ...

4. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2701631

Tai Ji Quan vs a Multimodal Exercise Intervention ... Thus, of the 3 exercise interventions, TJQMBB yielded the greatest reduction in number of falls, whereas both TJQMBB and multimodal exercise ...

5. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/hae.70040?af=R

Multimodal Exercise Program of Balance and Strength ... Based on the results, the MBSTP has been shown to be effective in improving balance, functionality, risk of falls and strength. However, it ...

6. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/63/NCT02374463/Prot_SAP_000.pdf

E1574-P NCT02374463 Improving Balance and Mobility ( ... We hypothesize that veterans at increased fall risk will have sarcopenia and dynapenia. Training should increase muscle mass and improve muscle quality as ...

7. bmcsportsscimedrehabil.biomedcentral.com bmcsportsscimedrehabil.biomedcentral.com/articles/10.1186/s13102-025-01214-2

Effects of a multi-modal static and dynamic balance and hand ... This study aims to investigate whether a combined balance and hand training program can provide programmatic references and empirical evidence ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1873959814000647

Original Article Effects of Simple Balance Training on ... Balance training of any type reduced falls by 17%, and the multimodal intervention that trained balance, strength, corrected environment, and medications was ...