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FallsVirtual MMBINCT07109466

Targeting the Hip Abductors to Reduce Falls in Older Veterans Through A Virtual Multimodal Balance Intervention

A study testing Mulit-modality Balance Intervention and Gerofit in people with Falls, run by VA Office of Research and Development at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Falls are a major health concern and a leading cause of injurious death and non-fatal injuries in older Veterans who are at greater risk for falls than non-Veterans. This in-person exercise intervention targeting changes in the hip muscles, known to play a major role in balance, has been effective at reducing falls in… Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Falls
What is being tested?
Mulit-modality Balance Intervention and Gerofit
Could I receive a placebo?
No, everyone receives an active treatment
How many people
110 participants
Where
1 siteUnited States
Study dates
28 Sep 2026to 3 Nov 2031
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • Veteran Status
  • VA Primary Care Provider
  • Enrolled in the VA Maryland Health Care System for health care
  • At risk for falls

Who cannot join

  • Poorly controlled hypertension
  • Home oxygen use
  • Contraindications to exercise or resistance exercise
  • Significant cognitive impairment
  • Other medical condition precluding patient participation in this study as per medical judgment of study team

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Bailey Rammling, MS contact

(443) 488-3749

bailey.rammling@va.gov

United States1 site, 1 recruiting
  • Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    Baltimore, Maryland, 21201

    Odessa R Addison, PhD DPT, (410) 605-7000 ext. 5393, Odessa.Addison@va.gov

    Jeffrey P Beans, BS, (410) 605-7000 ext. 4168, jeffrey.beans@va.gov

    Recruiting

Other trials in United States

About this study

Falls are a major health concern and a leading cause of injurious death and non-fatal injuries in older Veterans who are at greater risk for falls than non-Veterans. This in-person exercise intervention targeting changes in the hip muscles, known to play a major role in balance, has been effective at reducing falls in older Veterans. Gerofit is a VA best practice health promotion program that demonstrates good success in engaging Veterans in exercise. However, the role of Gerofit in fall prevention is unknown. Some Veterans may require additional training prior to participation in Gerofit to maximize the benefits of Gerofit. The proposed intervention will use novel home-based methods of exercise to improve hip muscles prior to participating in Gerofit. The goal of this study is to evaluate if a live virtual home-based multimodal balance intervention done prior to Gerofit compared to Gerofit alone will have a greater benefit on fall risk reduction and improved muscle and mobility function.

Read the detailed description

Falls are multifactorial in origin, with a failure to negotiate environmental hazards, muscle weakness, impaired postural control, and gait and balance deficits among the top contributors. Common between these is impaired lower extremity function, including difficulties during walking, incident slips and trips, or an inability to effectively recover after a loss of balance. The multifactorial origin of falls requires a multimodal approach to effectively reduce risk. The CDC currently includes 17 exercise interventions targeting fall reduction, and most of these programs reportedly decrease fall risk by ~30%. The investigators' MMBI program, developed over the last ten years, is unique in its approach to exercise for fall prevention. It has been developed in older Veterans at high risk for falls, who suffer an average of 16 comorbid health conditions. Further, the target of the hip abductors and multiple planes of movement with functional exercises and progressive lower extremity strengthening is unique to the MMBI program. While some programs have been widely studied, the majority do not have validated benefit to mechanistic outcomes, such as changes in muscle quality or intermuscular adipose tissue. In an on-going systematic review of studies that utilize a live-virtual format for fall prevention, the investigators found only 4 of 16 studies looked at falls at baseline and post-intervention. No studies utilizing the live virtual format followed individuals for a year after intervention to assess the long-term intervention effects. Most falls occur during walking, after incident slips and trips, such that targeted interventions to avoid loss of balance focused on stepping, obstacle negotiation, and walking ability -while also strengthening the muscles critical for balance recovery- are critical to reducing falls. Recent guidelines also suggest that any older adults with impaired gait or balance (slow gait speed or high TUG or FSST time) should be offered tailored exercise focused on balance, gait and strength to prevent future falls. This MMBI program is unique in that it targets not only strengthening but also functional movements in multiple plans to target the hip abductors, improve balance and reduce falls.

This study will address several important knowledge gaps, first by simply assessing the effect of the live virtual Gerofit program on balance and falls. It will also determine whether proven methods of improving balance and hip abductor strength can be safely and effectively translated to novel home delivery for Veterans, using an established standard of care control, and clinically important outcomes of fall rate, muscle strength, and muscle quality via CT scan. This will provide critical information for future fall prevention studies in the VA. In prior studies examining the effects of resistance training on balance, less than 30% of all trials included any resistance training of the hip abductors. Further, the investigators are unaware of any trial that currently targets the hip abductors with a virtual or home-based fall risk reduction intervention in a group that are at increased risk for falls. Understanding mechanistic contributions of the hip abductors to balance and mobility, and finding targeted means to improve their function without the need for center-based exercise opens important new treatment options for older Veterans with mobility limitations at increased fall risk. The investigators will do this through the following Aims.

Aim 1: Determine the 12-week effects of vMMBI vs vGerofit alone on clinical measures of fall risk, physical function, and fear of falling. It is hypothesized greater improvements in fall risk (four-square step test [primary outcome]) following 12 weeks of vMMBI compared to 12 weeks of vGerofit.

Aim 2: Determine the 12-week effects of vMMBI vs vGerofit alone on hip abductor mechanisms of fall prevention, including hip abductor function, hypertrophy, and quality. It is hypothesized that Veterans in the vMMBI group will demonstrate greater improvements in hip abductor (gluteus minimus/medius) function (muscle strength - determined with hand-held dynamometer [primary outcome]) due to the synergistic effects of resistance training combined with balance and mobility exercises, which may enhance muscle hypertrophy of the hip abductors (cross-sectional area) and improve muscle quality (% intramuscular fat by computed tomography).

Clinical Translational Aim: Determine the efficacy of participation in vMMBI+vGerofit vs vGerofit alone as indicated by the incidence of falls and exercise adherence.

Conditions
Falls
Being tested
Mulit-modality Balance Intervention, Gerofit
Keywords
Fall

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Mulit-modality Balance InterventionOther

    Also called MMI

    Participants will attend a virtual group balance class that focuses on movement and obstacle negotiation 3 times per week for 3-months

  • GerofitOther

    Participation in a virtual wellness program that consists of a warm up, aerobic training, and general strength training 3-times per week for up to 12 months

Study groups in NCT07109466
Study groupRoleWhat they receive
MMBI + GerofitExperimentalParticipation in a virtual multi-modality balance intervention that targets the hip abductors for 3-months followed by 9 months participation in virtual Gerofit
Receives: Other: Mulit-modality Balance Intervention; Other: Gerofit
GerofitActive comparatorParticipation in a virtual wellness program that consists of a warm up, aerobic training, and general strength training
Receives: Other: Gerofit

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Balance

    The four-square step test will be used as a measure of balance. The change in the amount of time it takes to complete the four-square step test comparing pre and post-intervention.

    Measured: 3-months

  2. Isometric Hip Abductor Strength

    A measure of the maximal isometric muscle strength produced in hip abductor muscles will be assessed with a handheld dynamometer device. Pre-test levels will be compared to post-intervention levels.

    Measured: 3-months

Secondary outcomes (1)
  1. Mobility

    The Timed up and Go will be used as a measure of mobility. The change in the amount of time it takes to complete the timed up and go test is comparing pre to post-intervention levels.

    Measured: 3-months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Aug 2025
  2. Study start28 Sep 2026
  3. Primary completion1 Nov 2030 (estimated)
  4. Study completion3 Nov 2031 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
110 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07109466
Sponsor's protocol ID
RRD6-005-24W
Other IDs
I01RD000434
Acronym
Virtual MMBI
Status last verified
Sep 2026
First submitted
31 Jul 2025
Last updated
2 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Mulit-modality Balance Intervention and Gerofit in people with Falls, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 2 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Jeffrey P Beans, BS ((410) 605-7000 ext. 4168, jeffrey.beans@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Balance (time frame: 3-months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2026.

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