Postural BalanceIMAGINE+NMESNCT02992275
NMES to Improve Hip Abductor Strength and Balance
A study testing Neuromuscular electrical stimulation (NMES) and Multi-Modality Balance Intervention (MMBI) in people with Postural Balance, run by Baltimore VA Medical Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Postural Balance
- What is being tested?
- Neuromuscular electrical stimulation (NMES) and Multi-Modality Balance Intervention (MMBI)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jun 2017to 31 Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- -
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Baltimore VA Medical Center
Baltimore, Maryland, 21201
About this study
Official title: 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.
Read the 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.
- Conditions
- Postural Balance
- Being tested
- Neuromuscular electrical stimulation (NMES), Multi-Modality Balance Intervention (MMBI)
- Keywords
- Hip, Muscle, Skeletal/physiopathology
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| NMES + MMBI | Experimental | Neuromuscular electrical stimulation applied to hip abductors along with participation in a multi-modality balance intervention Receives: Other: Neuromuscular electrical stimulation (NMES); Other: Multi-Modality Balance Intervention (MMBI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mobility
Mobility will be measured with the use of the mini-BesTest
Measured: 6 months
Secondary outcomes (2)
Balance
Balance will be measured with the four-square step test
Measured: 6-months
Muscle Strength
Muscle strength will be measured as hip abductor strength quantified by use of a biodex
Measured: 6-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Dec 2016 (estimated)
- Study start1 Jun 2017
- Primary completion1 Oct 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postural BalanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baltimore VA Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Odessa Addison, Baltimore VA Medical Center
- Investigators
- Les Katzel, MD, PhD, Study director, Director Baltmore GRECCOdessa Addison, DPT, PhD, Principal investigator, Research Scientist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02992275
- Sponsor's protocol ID
- HP-00072630
- Acronym
- IMAGINE+NMES
- Status last verified
- Feb 2023
- First submitted
- 12 Dec 2016
- Last updated
- 8 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neuromuscular Electrical Stimulation as an Adjunct to Improve Hip Abductor Muscle Quality and Reduce Fall Risk
- ClinicalTrials.gov ID
- NCT02992275
- Acronym / sponsor ID
- IMAGINE+NMES / HP-00072630
- Conditions
- Postural Balance
- Keywords
- Hip, Muscle, Skeletal/physiopathology
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Baltimore VA Medical CenterUS federal agency
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 14 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NMES + MMBI | Experimental | Other: Neuromuscular electrical stimulation (NMES), Other: Multi-Modality Balance Intervention (MMBI)Neuromuscular electrical stimulation applied to hip abductors along with participation in a multi-modality balance intervention |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
- -
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulation (NMES)Participants will receive NMES to the hip abductors while performing strength training 3 times per week for 24 weeks | Other | NMES + MMBI |
| 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 | Other | NMES + MMBI |
Primary outcome
Mobility
Time frame: 6 months
Mobility will be measured with the use of the mini-BesTest
2 secondary outcomes
Balance
Time frame: 6-months
Muscle Strength
Time frame: 6-months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Les Katzel, MD, PhD study director
Director Baltmore GRECC
Odessa Addison, DPT, PhD principal investigator
Research Scientist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuromuscular electrical stimulation (NMES) and Multi-Modality Balance Intervention (MMBI) in people with Postural Balance, run by Baltimore VA Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mobility (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2023.