NMES to Improve Hip Abductor Strength and Balance (IMAGINE+NMES)

Neuromuscular Electrical Stimulation as an Adjunct to Improve Hip Abductor Muscle Quality and Reduce Fall Risk

This study will examine the addition of neuromuscular electrical stimulation (NMES) on the hip abductors during strength training and a fall prevention program for improving muscle strength and improving balance. All individuals in this study will receive NMES to their hip abductors and will participate in a fall reduction program.

Study Overview

• Status: Completed
• Conditions: Postural Balance
• Intervention / Treatment: Other: Neuromuscular electrical stimulation (NMES); Other: Multi-Modality Balance Intervention (MMBI)

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. Our 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. We propose that a targeted multimodality balance intervention (MMBI) focused on the lateral and diagonal stepping and hip abductor strengthening when combined with NMES will result in improvements in mobility and balance.

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21201
      • Baltimore VA Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

Mobility and balance limitations as demonstrated by a self-reported fall within the past year or requiring greater than 8 seconds to complete the 4-square step test

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Exclusion Criteria:

1. Cardiovascular Risks: Poorly controlled hypertension (>160/100); or patient report of: symptomatic angina at rest or during exercise, syncope without known resolution of cause, or a significant coronary event (such as a MI) in the past six months
2. COPD requiring home oxygen
3. Contraindications to resistance training, including a self-reported history of intracranial or retinal bleeding in the last year or Diabetes with active proliferative retinopathy
4. Patient report of significant spinal stenosis that would limit participation in the exercise intervention
5. Non-ambulatory mobility status or a transtibial or transfemoral amputation
6. Dementia (on medical record review or mini-mental status exam score <24).
7. Other severe medical illness or condition that would preclude safe participation in the study as determined by the study team

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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 24 weeks; 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 24 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mobility	Mobility will be measured with the use of the mini-BesTest	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Balance	Balance will be measured with the four-square step test	6-months
Muscle Strength	Muscle strength will be measured as hip abductor strength quantified by use of a biodex	6-months

Collaborators and Investigators

• Sponsor: Baltimore VA Medical Center
• Investigators: Study Director: Les Katzel, MD, PhD, Director Baltmore GRECC; Principal Investigator: Odessa Addison, DPT, PhD, Research Scientist

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2017
• Primary Completion (ACTUAL): October 1, 2021
• Study Completion (ACTUAL): December 31, 2022

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 13, 2016
• First Posted (ESTIMATE): December 14, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 8, 2023
• Last Update Submitted That Met QC Criteria: February 6, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Keywords: Hip; Muscle; Skeletal/physiopathology
• Other Study ID Numbers: HP-00072630

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No