NCT07109466

Brief 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 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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable

Timeline
62mo left

Started Oct 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 7, 2025

Completed
1.2 years until next milestone

Study Start

First participant enrolled

October 1, 2026

Expected
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2030

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

November 3, 2031

Last Updated

April 9, 2026

Status Verified

April 1, 2026

Enrollment Period

4.1 years

First QC Date

July 31, 2025

Last Update Submit

April 3, 2026

Conditions

Keywords

Fall

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    3-months

Secondary Outcomes (1)

  • Mobility

    3-months

Study Arms (2)

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

Other: Mulit-modality Balance InterventionOther: Gerofit

Gerofit

ACTIVE COMPARATOR

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

Other: Gerofit

Interventions

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

Also known as: MMI
MMBI + Gerofit
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

GerofitMMBI + Gerofit

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • Veteran Status
  • years or older
  • VA primary Care provider
  • Enrolled in the VA Maryland Health Care System for health care
  • At risk for Falls

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Baltimore, Maryland, 21201, United States

Location

Study Officials

  • Odessa R. Addison, PhD DPT

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

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jeffrey P Beans, BS

CONTACT

Rhianna Patel, MS

CONTACT

Study Design

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

Study Record Dates

First Submitted

July 31, 2025

First Posted

August 7, 2025

Study Start (Estimated)

October 1, 2026

Primary Completion (Estimated)

November 1, 2030

Study Completion (Estimated)

November 3, 2031

Last Updated

April 9, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations