Reducing Fall Risk With NMES

Falls Clinical Trial

— NMES  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04969094
• Other study ID #: E3484-R
• Secondary ID: RX003484
• Status: Recruiting
• Phase: N/A
• Start date: January 4, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: VA Office of Research and Development
• Contact: Jeffrey P Beans, BS
• Phone: (410) 605-7000
• Email: jeffrey.beans[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Falls

Intervention

Other:
• Neuromuscular electrical stimulation (NMES)
Participants will receive NMES to the hip abductors while performing strength training 3 times per week for 3-months
• 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

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Mobility	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.	3-months
Secondary	Muscle composition	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-months
Secondary	Balance	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.	12-months after Exercise completion
Secondary	Isometric Hip Abductor Strength	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.	12-months after Exercise completion