Reducing Fall Risk With the Use of Neuromuscular Electrical Stimulation to Maximize the Hip Abductor Muscles in Older Veterans
| Registry | NCT04969094, acronym NMES |
|---|---|
| Status | Active not recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, treatment |
| Enrollment | 81 (Actual) |
| Sponsor | VA Office of Research and Development (Fed) |
| Conditions | Falls |
| Interventions | Neuromuscular electrical stimulation (NMES), Multi-Modality Balance Intervention (MMBI) (Other) |
| Dates | start 2022-01-04, primary completion 2026-12-20 (estimated), completion 2026-12-20 (estimated), first posted 2021-07-20, last updated 2026-08-06 |
| Locations | 1 site in United States |
Related Papers Related Patents Related Grants Related Experts
All trials for Falls All trials of Neuromuscular electrical stimulation (NMES) All trials of Multi-Modality Balance Intervention (MMBI)
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.
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
| Arm | Type | Interventions | Description |
|---|---|---|---|
| NMES + MMBI | Experimental | Other: Neuromuscular electrical stimulation (NMES); Other: Multi-Modality Balance Intervention (MMBI) | Neuromuscular electrical stimulation applied to hip abductors along with participation in a multi-modality balance intervention |
| MMBI | Active comparator | Other: Multi-Modality Balance Intervention (MMBI) | Participation in a multi-modality balance intervention |
Sex: All, ages: 55 Years to any
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
| Facility | City | Country | Status |
|---|---|---|---|
| Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD | Baltimore, Maryland | United States |