Reducing Fall Risk With NMES

NCT ID: NCT04969094

Last Updated: 2026-01-08

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 81 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-04
• Study Completion Date: 2027-01-29

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.

Detailed Description

Falls are a leading cause of disability in older adults. Decreased lower extremity muscle mass and strength contribute to balance and mobility limitations. More recent work also suggests that in addition to the traditional targets of muscle mass of the thigh and leg muscles, dysfunction of the hip abductors may contribute to balance and mobility limitations resulting in increased fall risk. Older adults with impaired hip abductor muscles demonstrate increased amounts of intramuscular fat (IMAT) in and around the muscles, decreased hip abductor strength, lower balance scores, increased gait variability (a predictor of future falls), and poor stepping mechanics when recovering from a balance perturbation. Increased IMAT and muscle dysfunction of the hip abductors may contribute to poor hip abductor muscle recruitment and make changing these muscle during a traditional intervention difficult. Neuromuscular electrical stimulation (NMES) is one method to improve muscle mass, strength and quality in older adults, but has not traditionally been used on the hip abductors. The investigator's central hypothesis is that the addition of NMES applied to the primary hip abductors during a multimodality balance intervention (MMBI) will result in greater reduction in fall risk and larger improvements in muscle and mobility function than MMBI alone. The investigators will test this hypothesis with the following specific aims:

Aim 1: To determine the 3-month effects of a multimodality balance intervention with and without NMES on fall risk.

Aim 2: To examine the 3-month effects of a multimodality balance intervention with and without NMES on functional outcomes including muscle function and composition.

Aim 3: To evaluate the retention of balance, muscle changes and reduced falls after a multimodality balance intervention with and without NMES

Conditions

Falls

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

NMES + MMBI

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

Group Type: EXPERIMENTAL

Neuromuscular electrical stimulation (NMES)

Intervention Type: OTHER

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

Multi-Modality Balance Intervention (MMBI)

Intervention Type: OTHER

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

MMBI

Participation in a multi-modality balance intervention

Group Type: ACTIVE_COMPARATOR

Multi-Modality Balance Intervention (MMBI)

Intervention Type: OTHER

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

Interventions

Neuromuscular electrical stimulation (NMES)

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

Intervention Type: OTHER

Multi-Modality Balance Intervention (MMBI)

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 55 years or older
• At risk for falls

Exclusion Criteria

• 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

• Minimum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Odessa R. Addison, PhD DPT

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 40312027 (View on PubMed)

Other Identifiers

RX003484

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

E3484-R

Identifier Type: -

Identifier Source: org_study_id