NMES to Improve Hip Abductor Strength and Balance

Postural Balance Clinical Trial

— IMAGINE+NMES  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02992275
• Other study ID #: HP-00072630
• Status: Completed
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 31, 2022

Study information

• Verified date: February 2023
• Source: Baltimore VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: December 31, 2022
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 60 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Postural 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
• 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

Locations

Country	Name	City	State
United States	Baltimore VA Medical Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
Baltimore VA Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mobility	Mobility will be measured with the use of the mini-BesTest	6 months
Secondary	Balance	Balance will be measured with the four-square step test	6-months
Secondary	Muscle Strength	Muscle strength will be measured as hip abductor strength quantified by use of a biodex	6-months