Neuromuscular Electrical Stimulation and Physical Function in Older Adults

April 16, 2018 updated by: Joni Mettler, Texas State University

Impact of Neuromuscular Electrical Stimulation on Physical Function in Older Adults

The purpose of this placebo controlled clinical trial is to examine the effects of of neuromuscular electrical stimulation (NMES) training on physical activity, muscle function, self-efficacy, and blood markers [e.g., brain-derived neurotrophic factor (BDNF)] in older adults.

It is hypothesized that 4-weeks of NMES will increase 1) physical activity, 2) muscle function, 3) self-efficacy, and 4) BDNF in older adults.

Sarcopenia is a destructive progressive cycle of impaired physical function resulting in loss of muscle mass, strength, and self-confidence in ability to perform physical activities, compounded by difficulty walking and ultimately reduced physical activity levels for many older adults. Neuromuscular electrical stimulation (NMES) is a common therapeutic modality used to create involuntary muscle contractions as a means to increase muscle strength, and may be an effective treatment for improving muscle function and physical activity levels in older adults with sarcopenia. Thus, it is critical to explore viable and effective alternative therapies to increase physical activity. The goal of the investigators' is to determine the effectiveness of neuromuscular electrical stimulation (NMES) at increasing physical activity and related biological, psychological, and muscle function factors. This placebo controlled clinical trial will use a pre-test - post-test randomized experimental design.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Older healthy adults (60 and older) will participate in this study. Participants will undergo 4 weeks of neuromuscular electrical stimulation (NMES) training. Participants will be randomized into the one of two groups 1) NMES-millicurrent or 2) NMES microcurrent. Participants will undergo pre- and post-training testing for muscle function, physical function, and psychological variables related to physical activity. Blood samples will also be obtained pre- and post-training.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

60 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • generally healthy men and women
  • ages 60 and older

Exclusion Criteria:

  • 1) they have participated in regular resistance training exercise or physical rehabilitation of the lower extremity within 2 months of the study
  • 2) contraindicating conditions for electrical stimulation are present (i.e., swollen, infected or inflamed areas including open wounds, or painful areas on the lower limbs, implanted electronics including cardiac pacemakers, electronic infusion pumps, implanted stimulators, or surgical hardware in the lower limbs)
  • 3) they have current knee injury or knee pain
  • 4) have a neuromuscular disease
  • 5) currently taking insulin for diabetes regulation
  • 6) they have a history of seizures

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
EXPERIMENTAL: NMES-Millicurrent Group
NMES-millicurrent group will receive the NMES experimental treatment. Stimulating electrodes will be applied to the quadriceps muscle of each leg 3 times a week for 4 weeks (12 sessions) for 40min on each leg.
Other: NMES-Millicurrent
Stimulating electrodes will be applied to the quadriceps muscle of each leg 3 times a week for 4 weeks (12 sessions) for 40min per leg.
SHAM_COMPARATOR: NMES-Microcurrent Group
The NMES-microcurrent group will receive the Sham Treatment. The Sham Treatment will consist of electrode pad application for 40 mins on each leg, but electrical current will not be delivered. Otherwise all procedures will be the same as the NMES-millicurrent experimental group. Participants will be informed they are receiving microcurrent stimulation which is typically not felt by patients. Microcurrent stimulation is an actual type of electrical stimulation that is used therapeutically and is typically not felt by patients, however, participants will not receive this treatment. Participants will be informed of the actual treatment received at the study conclusion. Those in the Sham Group will be given the opportunity to receive the treatment at the conclusion of the study.
Other: NMES-Millicurrent
Stimulating electrodes will be applied to the quadriceps muscle of each leg 3 times a week for 4 weeks (12 sessions) for 40min per leg.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change in Physical Activity
Time Frame: Physical activity levels will be assessed for 1 week before the intervention and for 1 week after the intervention period. The change in physical activity will be compared between these two time-periods.
Physical activity will be measured from accelerometer data.
Physical activity levels will be assessed for 1 week before the intervention and for 1 week after the intervention period. The change in physical activity will be compared between these two time-periods.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in Muscle Strength
Time Frame: Muscle strength will be assessed prior to the first day of the intervention, after 2-weeks of the intervention, and two days after the completion of the 4-week intervention.
Muscle strength will be measured by maximal voluntary contraction on a dynamometer.
Muscle strength will be assessed prior to the first day of the intervention, after 2-weeks of the intervention, and two days after the completion of the 4-week intervention.
Change in Muscle Endurance
Time Frame: Muscle endurance will be assessed prior to the first day of the intervention and 2 days after the completion of the 4-week intervention.
Muscle endurance time will be measured on a dynamometer.
Muscle endurance will be assessed prior to the first day of the intervention and 2 days after the completion of the 4-week intervention.
Pre-training NMES-related change in glucose
Time Frame: Blood glucose will be measured immediately before and immediately after the application of the intervention on the first (training Day 1) NMES intervention day.
Fasting blood glucose levels will be measured.
Blood glucose will be measured immediately before and immediately after the application of the intervention on the first (training Day 1) NMES intervention day.
Post-training NMES-related change in glucose
Time Frame: Blood glucose will be measured immediately before and immediately after the application of the intervention on the last day (training day 12) of the NMES intervention.
Fasting blood glucose levels will be measured.
Blood glucose will be measured immediately before and immediately after the application of the intervention on the last day (training day 12) of the NMES intervention.
Pre-training NMES-related change in Brain-derived Neurotrophic Factor (BDNF) levels
Time Frame: BDNF levels will be measured immediately before and immediately after the application of the intervention on the first (training Day 1) NMES intervention day.
Brain-derived neurotrophic factor, a marker of neuronal growth, will be obtained from a blood sample.
BDNF levels will be measured immediately before and immediately after the application of the intervention on the first (training Day 1) NMES intervention day.
Post-intervention change in Brain-derived Neurotrophic Factor (BDNF) levels
Time Frame: BDNF levels will be measured immediately before and immediately after the application of the intervention on the last day (training day 12) of the NMES intervention.
Brain-derived neurotrophic factor, a marker of neuronal growth, will be obtained from a blood sample.
BDNF levels will be measured immediately before and immediately after the application of the intervention on the last day (training day 12) of the NMES intervention.
Change in self-efficacy of activities of daily living
Time Frame: Self-efficacy will be measured prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Self-efficacy will be measured by survey.
Self-efficacy will be measured prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in motor activation
Time Frame: Motor activation will be measured prior to the first day of the intervention and two days after the completion of the 4-week intervention.
Motor activation will be measured by surface electromyography measures.
Motor activation will be measured prior to the first day of the intervention and two days after the completion of the 4-week intervention.
Change in perception of pain
Time Frame: Perceptions of pain will be measured immediately after the NMES treatment on the first (training day 1) and last day (training day 12) of the 4-week intervention.
Perceived pain experienced during the NMES treatment will be measured by survey.
Perceptions of pain will be measured immediately after the NMES treatment on the first (training day 1) and last day (training day 12) of the 4-week intervention.
Physical activity during the 4-week intervention
Time Frame: Physical activity levels will be measured during the 4 weeks of the intervention (from the first day of the intervention through the last day of the intervention).
Physical activity will be measured from accelerometer data.
Physical activity levels will be measured during the 4 weeks of the intervention (from the first day of the intervention through the last day of the intervention).
Change in timed up and go test
Time Frame: Timed up and go test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
The timed up and go test will measure the time it takes to stand up from a chair, walk a few meters, turn around and sit back down.
Timed up and go test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in stair climb test
Time Frame: The stair cimb test test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
The stair climb test will assess the time it takes to safely ascend 10 stairs.
The stair cimb test test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in five repetition sit-to-stand test
Time Frame: The five repetition sit-to-stand test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
The five repetition sit-to-stand test will assess the time it take to stand up and sit down on a chair 5 times.
The five repetition sit-to-stand test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in 6-min walk test
Time Frame: The 6-min walk test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
The 6-min walk test will assess the distance an individual can walk in 6 minutes.
The 6-min walk test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in grip strength
Time Frame: The grip strength test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
The grip strength test will measure the maximal hand grip strength of both hand using a grip strength dynamometer.
The grip strength test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
Change in arm curl test
Time Frame: The arm curl test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.
The arm curl test will measure the number of repetitions completed with a dumbbell.
The arm curl test will be assessed prior to the first day of the intervention and 4 days after the last day of the 4-week intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Texas State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Joni A Mettler, PhD, Texas State University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 7, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 26, 2018

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 26, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • REPFY18

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

We do not plan to share data with other researches until the data are published in journals and presented at conferences.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Sarcopenia

Clinical Trials on NMES-Millicurrent

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings