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Clinical Trials/NCT02992275
NCT02992275CompletedNot Applicable

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

Baltimore VA Medical Center1 site in 1 country14 target enrollmentStarted: June 1, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
14
Locations
1
Primary Endpoint
Mobility

Study Overview

Brief Summary

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.

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 Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
60 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Exclusion Criteria

  • •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
  • •COPD requiring home oxygen
  • •Contraindications to resistance training, including a self-reported history of intracranial or retinal bleeding in the last year or Diabetes with active proliferative retinopathy
  • •Patient report of significant spinal stenosis that would limit participation in the exercise intervention
  • •Non-ambulatory mobility status or a transtibial or transfemoral amputation
  • •Dementia (on medical record review or mini-mental status exam score <24).
  • •Other severe medical illness or condition that would preclude safe participation in the study as determined by the study team

Arms & Interventions

NMES + MMBI

Experimental

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

Intervention: Neuromuscular electrical stimulation (NMES) (Other)

NMES + MMBI

Experimental

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

Intervention: Multi-Modality Balance Intervention (MMBI) (Other)

Outcomes

Primary Outcomes

Mobility

Time Frame: 6 months

Mobility will be measured with the use of the mini-BesTest

Secondary Outcomes

  • Balance(6-months)
  • Muscle Strength(6-months)

Investigators

Sponsor Class
Fed
Responsible Party
Principal Investigator
Principal Investigator

Odessa Addison

Research Scientist

Baltimore VA Medical Center

Study Sites (1)

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