Reducing Fall Risk With NMES

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Recruiting
CT.gov ID
NCT04969094
Collaborator
(none)
80
1
2
47.9
1.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Neuromuscular electrical stimulation (NMES)
  • Other: Multi-Modality Balance Intervention (MMBI)
N/A

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

Study Design

Study Type:
Interventional
Anticipated Enrollment :
80 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Reducing Fall Risk With the Use of Neuromuscular Electrical Stimulation to Maximize the Hip Abductor Muscles in Older Veterans
Actual Study Start Date :
Jan 4, 2022
Anticipated Primary Completion Date :
Dec 31, 2024
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
Experimental: NMES + MMBI

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

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

Active Comparator: MMBI

Participation in a multi-modality balance intervention

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

Outcome Measures

Primary Outcome Measures

  1. Balance [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 [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 Outcome Measures

  1. Mobility [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 [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 [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD Baltimore Maryland United States 21201

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Odessa R. Addison, PhD DPT, Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT04969094
Other Study ID Numbers:
  • E3484-R
  • RX003484
First Posted:
Jul 20, 2021
Last Update Posted:
Jan 24, 2022
Last Verified:
Jan 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
No
Keywords provided by VA Office of Research and Development

Study Results

No Results Posted as of Jan 24, 2022