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Completed

NCT Number: NCT02992275

NMES to Improve Hip Abductor Strength and Balance

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.

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Key information

Conditions

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Neuromuscular electrical stimulation (NMES)

Other

Participants will receive NMES to the hip abductors while performing strength training 3 times per week for 24 weeks

Multi-Modality Balance Intervention (MMBI)

Other

Participants will attend a group balance class that focuses on movement and obstacle negotiation 3 times per week for 24 weeks

Primary outcomes

  1. Mobility

    Time frame: 6 months

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

Secondary outcomes

  1. Balance

    Time frame: 6-months

    Balance will be measured with the four-square step test

  2. Muscle Strength

    Time frame: 6-months

    Muscle strength will be measured as hip abductor strength quantified by use of a biodex

Sponsors and collaborators

Lead sponsor

Baltimore VA Medical Center

Fed

Registry information

Official study title

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

Acronym: IMAGINE+NMES

Important dates

Study start
2017
Primary completion
2021
Study completion
2022
First posted
Dec 14, 2016
Registry last updated
Feb 8, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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