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NCT Number: NCT04969094

Reducing Fall Risk With NMES

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Age range

55 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Baltimore, Maryland, 21201, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular electrical stimulation (NMES)

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)

Other

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

Primary outcomes

  1. 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.

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

Secondary outcomes

  1. Mobility

    Time frame: 3-months

    The modified physical performance test is a mobility measure that utilizes 9 tasks scored 0-4 (total possible score 36) to determine functional status. Pre-test scores will be compared to post intervention test scores.

  2. Muscle composition

    Time frame: 3-months

    A measure of the amount of muscle and fat in the muscle using a CT scan of the hips. Pre-test levels will be compared to post intervention levels

  3. Balance

    Time frame: 12-months after Exercise completion

    The change in the amount of time it takes to complete the four-square step test comparing post-intervention to 12-months after the cessation of exercise.

  4. Isometric Hip Abductor Strength

    Time frame: 12-months after Exercise completion

    A measure of the maximal isometric muscle strength produced in hip abductor muscles will be assessed with a biodex device.. Post-intervention levels will be compared to 12 months after the cessation of exercise.

Sponsors and collaborators

Lead sponsor

VA Office of Research and Development

Fed

Registry information

Official study title

Reducing Fall Risk With the Use of Neuromuscular Electrical Stimulation to Maximize the Hip Abductor Muscles in Older Veterans

Acronym: NMES

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
Jul 20, 2021
Registry last updated
Mar 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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