NMES to Improve Hip Abductor Strength and Balance

NCT02992275 | Completed DMC

• 1 other identifier: HP-00072630
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Postural Balance

Keywords

Hip; Muscle; Skeletal/physiopathology

Outcome Measures

Primary Outcomes (1)

• Mobility

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

  6 months

Secondary Outcomes (2)

• Balance

  6-months

• Muscle Strength

  6-months

Study Arms (1)

NMES + MMBI

EXPERIMENTAL

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

Other: Neuromuscular electrical stimulation (NMES); Other: Multi-Modality Balance Intervention (MMBI)

Interventions

Neuromuscular electrical stimulation (NMES) OTHER

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

NMES + MMBI

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

NMES + MMBI

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Baltimore VA Medical Center: lead

Study Sites (1)

Baltimore VA Medical Center

Baltimore, Maryland, 21201, United States

Location

Study Officials

• Les Katzel, MD, PhD

  Director Baltmore GRECC

  STUDY DIRECTOR

• Odessa Addison, DPT, PhD

  Research Scientist

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Scientist

Study Record Dates

• First Submitted: December 12, 2016
• First Posted: December 14, 2016
• Study Start: June 1, 2017
• Primary Completion: October 1, 2021
• Study Completion: December 31, 2022
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)