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.
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.
United States1 site, 1 recruiting
- 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
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 group | Role | What they receive |
|---|---|---|
| MMBI + Gerofit | Experimental | Participation 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 |
| Gerofit | Active comparator | Participation 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.
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
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)
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.
- First posted7 Aug 2025
- Study start28 Sep 2026
- Primary completion1 Nov 2030 (estimated)
- Study completion3 Nov 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FallsStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Odessa R. Addison, PhD DPT, Principal investigator, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Targeting the Hip Abductors to Reduce Falls in Older Veterans Through A Virtual Multimodal Balance Intervention
- ClinicalTrials.gov ID
- NCT07109466
- Acronym / sponsor ID
- Virtual MMBI / RRD6-005-24W
- Conditions
- Falls
- Keywords
- Fall
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 1 Nov 2030 (estimated)
- Study completion
- 3 Nov 2031 (estimated)
- First posted
- 7 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MMBI + Gerofit | Experimental | Other: Mulit-modality Balance Intervention, Other: GerofitParticipation in a virtual multi-modality balance intervention that targets the hip abductors for 3-months followed by 9 months participation in virtual Gerofit |
| Gerofit | Active comparator | Other: GerofitParticipation in a virtual wellness program that consists of a warm up, aerobic training, and general strength training |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (4 listed)
- Veteran Status
- VA Primary Care Provider
- Enrolled in the VA Maryland Health Care System for health care
- At risk for falls
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mulit-modality Balance InterventionAlso: MMIParticipants will attend a virtual group balance class that focuses on movement and obstacle negotiation 3 times per week for 3-months | Other | MMBI + Gerofit |
| GerofitParticipation 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 | Other | Gerofit, MMBI + Gerofit |
Primary outcome
Balance
Time frame: 3-months
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.
Isometric Hip Abductor Strength
Time frame: 3-months
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.
1 secondary outcome
Mobility
Time frame: 3-months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Odessa R. Addison, PhD DPT principal investigator
Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD
1 site in 1 country: see every site and its status.
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.