NCT04969094

Brief Summary

Falls are dangerous leading to injuries, hospital admissions and even death. Fall prevention is a priority but effective programs only reduce falls by 30%. Weak hip muscles may be one reasons individuals experience a loss of balance. However individuals who have weak hip muscles may be unable to exercise at sufficient intensities to improve their hip muscle strength. The purpose of this study is to utilize a common physical therapy method, neuromuscular electrical stimulation (NMES), on the hip muscles to improve hip muscle strength and improve balance. The new program focuses on using NMES during a resistance training program along with exercise to improve standing balance, walking and stepping over objects. This study will test the additive effect of NMES applied to the hip muscles during a balance and strengthening program to improve balance and mobility, and ultimately reduce the risk of falls in older Veterans at high risk for falls.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
9mo left

Started Jan 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress86%
Jan 2022Jan 2027

First Submitted

Initial submission to the registry

July 7, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 20, 2021

Completed
6 months until next milestone

Study Start

First participant enrolled

January 4, 2022

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2026

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2027

Expected
Last Updated

March 30, 2026

Status Verified

March 1, 2026

Enrollment Period

4.1 years

First QC Date

July 7, 2021

Last Update Submit

March 24, 2026

Conditions

Falls

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 biodex device. Pre-test levels will be compared to post-intervention levels.

    3-months

Secondary Outcomes (4)

  • Mobility

    3-months

  • Muscle composition

    3-months

  • Balance

    12-months after Exercise completion

  • Isometric Hip Abductor Strength

    12-months after Exercise completion

Study Arms (2)

NMES + MMBI

EXPERIMENTAL

Neuromuscular electrical stimulation applied to hip abductors along with participation in a multi-modality balance intervention

Other: Neuromuscular electrical stimulation (NMES)Other: Multi-Modality Balance Intervention (MMBI)

MMBI

ACTIVE COMPARATOR

Participation in a multi-modality balance intervention

Other: Multi-Modality Balance Intervention (MMBI)

Interventions

Multi-Modality Balance Intervention (MMBI)OTHER

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

MMBINMES + MMBI
Neuromuscular electrical stimulation (NMES)OTHER

Participants will receive NMES to the hip abductors while performing strength training 3 times per week for 3-months

NMES + MMBI

Eligibility Criteria

Age55 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years or older
  • At risk for falls

You may not qualify if:

  • Poorly controlled hypertension
  • Home oxygen use
  • Contraindications to resistance exercise
  • Contraindications for NMES use
  • Dementia
  • 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

Related Publications (1)

  • Friedman B, Beamer BA, Beans J, Gray V, Alon G, Ryan A, Katzel LI, Sorkin JD, Addison O. Neuromuscular Electrical Stimulation to Maximize Hip Abductor Strength and Reduce Fall Risk in Older Veterans: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2025 May 1;14:e68082. doi: 10.2196/68082.

    PMID: 40312027DERIVED

Study Officials

  • Odessa R. Addison, PhD DPT

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

    PRINCIPAL INVESTIGATOR

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 7, 2021

First Posted

July 20, 2021

Study Start

January 4, 2022

Primary Completion

January 30, 2026

Study Completion (Estimated)

January 29, 2027

Last Updated

March 30, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)