AgingNCT06689618
Effects of Whole-body Electrical Muscle Stimulation Exercise on Spinal Motoneuronal Activation in Older Adults
A study testing Exercise in people with Aging and Sarcopenia, run by University of Missouri-Columbia at 1 site in United States.
Trial summary
During this pilot study, the investigators will examine the effects of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) on motoneuronal activation in healthy adults, which typically decreases with age. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Sarcopenia, Sarcopenia in Elderly
- What is being tested?
- Exercise
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2025to 30 Jun 2026
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age (65 years or older) for healthy older adults and between 18-39 for healthy younger adults
- Ambulatory without an assistive device
- More than anti-gravity strength in major muscle groups as assessed by manual muscle testing
- Medical clearance to participate in an exercise program
- Ability to conform to the requirements of the study (i.e. attendance at assessment and intervention visits, maintain current level of non-study physical activity for the duration of the study, no intention to relocate mid-study)
Who cannot join
- Regular use of an assistive device for mobility (i.e. cane, walker, wheelchair)
- Presence of a pacemaker, metal implants, or other implanted medical devices that could impact participant safety during WB-EMS intervention
- Known pregnancy at the time of screening
- Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease cardia arrhythmia, neoplasm, uncontrolled hypertension)
- Presence of terminal disease (i.e. receiving hospice services)
- Current of previous use of any drugs known to influence muscle mass or performance within 6 months; these may include but are not limited to anabolic steroids, IGF01, growth hormone, replacement and androgen therapy, anti-androgen therapy.
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- Known neuromuscular or neurologic condition affecting somatosensory or motor function/control (i.e. motor neuron disease, muscle disease, severe peripheral neuropathy, NMJ disease, Parkinson's disease, Multiple Sclerosis, h/o stroke, TBI, SCI, ataxia, apraxia, hemiplegia, etc.)
- Musculoskeletal condition or surgery in the past year that would confound results of exercise interventions (i.e. TKA, THA, RTC repair, spinal fusion)
- Other medical conditions, signs, or symptoms that would interfere with study conduct or interpretation of results as determined by a PI
Trial locations and contacts
1 site in 1 country.
United States1 site
NextGen Precision Health Building, Clinical and Translational Science Unit
Columbia, Missouri, 65211
About this study
During this pilot study, the investigators will examine the effects of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) on motoneuronal activation in healthy adults, which typically decreases with age. The investigators will also test whether WB-EMS Exercise will improve measures of physical function. Participants will undergo clinical and electrophysiologic testing before and after the WB-EMS Exercise intervention. The WB-EMS Exercise intervention will be delivered two times per week for four weeks. The hypothesis is that whole-body electrical muscle stimulation combined with physical exercise (WB-EMS Exercise) could bypass the problem of insufficient motoneuronal activation to improve exercise effect in older adults.
Read the detailed description
During this pilot study, the investigators will examine the effects of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) on motoneuronal activation in healthy adults, which typically decreases with age. The investigators will also test whether WB-EMS Exercise will improve measures of physical function. The intervention consists of WB-EMS Exercise twice a week for four weeks. The investigators will use decomposition electromyography, interpolated twitch technique, and clinical measures to assess pre- and post-treatment motoneuronal activation and physical functioning. Correlation matrices will be performed associating the measures of motoneuronal activation to the measures of physical function (pre-intervention values, post-intervention values, and change values). At the conclusion of the study, expected outcomes include that whole-body electrical muscle stimulation combined with physical exercise (WB-EMS Exercise) could bypass the problem of insufficient motoneuronal activation to improve exercise effect in older adults. This project represents early work to uncover motoneuronal mechanisms of WB-EMS Exercise in older adults. An intervention that combines voluntary and involuntary activation of motoneurons to enhance the effectiveness of exercise could have significant impact in maximizing the functional independence of an aging population.
- Conditions
- Aging, Sarcopenia, Sarcopenia in Elderly
- Being tested
- Exercise
- Keywords
- Aging, Motoneuronal Activation, Electrical Stimulation, Whole-Body Stimulation, Sarcopenia, Exercise Intervention, Exercise
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseDevice
Also called Whole-Body Electrical Stimulation
The WB-EMS Device is a fitness device that delivers whole-body electrical muscle stimulation in conjunction with exercise programs. After donning a base layer consisting of fitted shorts and shirt, a vest, shorts, and arm straps with integrated electrodes mapped to major muscle groups (biceps, triceps, pectorals, abdominals, periscapular musculature, paraspinal musculature, gluteus musculature, quadriceps, and hamstrings) are donned. The suit connects to an impulse pack that communicates with the Katalyst iPad App to deliver the programmed stimulation to the participant. Within the Katalyst App, there are leveled exercise programs where low levels (i.e. Level 1 and 2) are simple movements and higher levels (i.e. Levels 3, 4, and 5) have more complex and dynamic movements. There is complete user control of the stimulation level of each individual muscle group to tailor to participant responses and tolerance.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Adults | Experimental | All participants will receive the WB-EMS Exercise intervention 2 times per week for 4 weeks. Participants will only perform leveled exercise programs in the "Strength" Training Mode. These programs are 20-minute videos led by exercise professionals. They are full-body workouts with no one muscle group receiving more attention than another. They consist of 10-12 exercises performed for 14 repetitions. Each repetition takes 4 seconds to complete (the time that the stimulation is "on") and is followed by a 4 second rest (the time that the stimulation is "off"). All exercises occur in a double-limb stance position. Most exercises occur with feet in wide base of support, hips width or more apart. All exercises are modifiable by the healthcare professional administering and monitoring the intervention based on participant's safe and available range of motion (i.e. arm movements, torso positions, extent of knee bend). Receives: Device: Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from baseline in motor unit firing rates of the vastus lateralis using decomposition electromyography (dEMG)
Decomposition electromyography (dEMG) is a measurement of motor unit activity; a surface electrode will be placed over the vastus lateralis in the thigh and participants will be asked to activate that muscle.
Measured: Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Mean change from baseline in central activation ratio of the vastus lateralis using interpolated twitch technique (ITT)
The central activation ratio (CAR) is a representation of how completely a person can voluntarily access their maximum force production capacity. Surface electrodes will be placed over the vastus lateralis in the thigh and participants will be asked to activate that muscle.
Measured: Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Secondary outcomes (3)
Mean change from baseline in mobility testing
To capture changes in common functional movements relevant to maintenance of independence for older adults, the investigators will collect data on gait speed (10-m walk/run test), stair negotiation (4-stair ascent and descent), rising from/lowering to a chair (30 second sit to stand), and lowering to/rising from the floor (floor transfer test).
Measured: Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Mean change from baseline in balance testing
The Balance Outcome Measure for Elder Rehabilitation (BOOMER) is an older adult-specific measure of balance. It is a composite test consisting of a Step Test (tapping a step with one foot as many times as safely possible in 15 seconds), the Timed Up and Go (TUG; rise from a chair, walk 3 meters, turn around, and return to sitting in chair), the Functional Reach Test (FRT; standing forward reach with arms outstretched as far as a person can control), and a Timed Static Stance (narrow stance, eyes closed for up to 90 seconds). Participants will also complete the Single Leg Hop test and the Star Excursion Test.
Measured: Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Treatment Feedback Questionnaire
The Treatment Feedback Questionnaire was created by the principal investigator to systematically collect meaningful feedback from the participants regarding their opinions, impressions, and recommendations about the WB-EMS Exercise intervention. This is part of an ongoing effort to develop exercise interventions that are effective and patient-centered and can be adopted and sustained to promote long-term health.
Measured: Measured within 3 days of completing the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start18 Aug 2025
- Primary completion5 May 2026
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- More trials run by University of Missouri-ColumbiaThe sponsor's other registered studies.
- 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
- Model description
- Enrolled participants will undergo pre-test assessments within 2-4 days before and after the intervention period. The pre-test assessment visit will be scheduled for 3.5 hours, and the post-test assessment visit for 2.5 hours, reflecting that the pre-test visit will incorporate consenting and screening procedures. The intervention will consist of 2 visits per week for 4 weeks; each intervention visit will be scheduled for 1.5 hours.
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Missouri-Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristina Kelly, University of Missouri-Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689618
- Sponsor's protocol ID
- 2116666
- Status last verified
- Feb 2026
- First submitted
- 13 Nov 2024
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Whole-body Electrical Muscle Stimulation Exercise on Spinal Motoneuronal Activation in Older Adults
- ClinicalTrials.gov ID
- NCT06689618
- Acronym / sponsor ID
- 2116666
- Conditions
- Aging, Sarcopenia, Sarcopenia in Elderly
- Keywords
- Aging, Motoneuronal Activation, Electrical Stimulation, Whole-Body Stimulation, Sarcopenia, Exercise Intervention, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Missouri-ColumbiaUniversity, hospital or other
- Study start
- 18 Aug 2025 (actual)
- Primary completion
- 5 May 2026 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 14 Nov 2024 (actual)
- 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.
During this pilot study, the investigators will examine the effects of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) on motoneuronal activation in healthy adults, which typically decreases with age. The investigators will also test whether WB-EMS Exercise will improve measures of physical function. Participants will undergo clinical and electrophysiologic testing before and after the WB-EMS Exercise intervention. The WB-EMS Exercise intervention will be delivered two times per week for four weeks. The hypothesis is that whole-body electrical muscle stimulation combined with physical exercise (WB-EMS Exercise) could bypass the problem of insufficient motoneuronal activation to improve exercise effect in older adults.
Detailed description
During this pilot study, the investigators will examine the effects of whole-body electrical muscle stimulation exercise (WB-EMS Exercise) on motoneuronal activation in healthy adults, which typically decreases with age. The investigators will also test whether WB-EMS Exercise will improve measures of physical function. The intervention consists of WB-EMS Exercise twice a week for four weeks. The investigators will use decomposition electromyography, interpolated twitch technique, and clinical measures to assess pre- and post-treatment motoneuronal activation and physical functioning. Correlation matrices will be performed associating the measures of motoneuronal activation to the measures of physical function (pre-intervention values, post-intervention values, and change values). At the conclusion of the study, expected outcomes include that whole-body electrical muscle stimulation combined with physical exercise (WB-EMS Exercise) could bypass the problem of insufficient motoneuronal activation to improve exercise effect in older adults. This project represents early work to uncover motoneuronal mechanisms of WB-EMS Exercise in older adults. An intervention that combines voluntary and involuntary activation of motoneurons to enhance the effectiveness of exercise could have significant impact in maximizing the functional independence of an aging population.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Enrolled participants will undergo pre-test assessments within 2-4 days before and after the intervention period. The pre-test assessment visit will be scheduled for 3.5 hours, and the post-test assessment visit for 2.5 hours, reflecting that the pre-test visit will incorporate consenting and screening procedures. The intervention will consist of 2 visits per week for 4 weeks; each intervention visit will be scheduled for 1.5 hours.
| Arm | Type | Receives |
|---|---|---|
| Healthy Adults | Experimental | Device: ExerciseAll participants will receive the WB-EMS Exercise intervention 2 times per week for 4 weeks. Participants will only perform leveled exercise programs in the "Strength" Training Mode. These programs are 20-minute videos led by exercise professionals. They are full-body workouts with no one muscle group receiving more attention than another. They consist of 10-12 exercises performed for 14 repetitions. Each repetition takes 4 seconds to complete (the time that the stimulation is "on") and is followed by a 4 second rest (the time that the stimulation is "off"). All exercises occur in a double-limb stance position. Most exercises occur with feet in wide base of support, hips width or more apart. All exercises are modifiable by the healthcare professional administering and monitoring the intervention based on participant's safe and available range of motion (i.e. arm movements, torso positions, extent of knee bend). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age (65 years or older) for healthy older adults and between 18-39 for healthy younger adults
- Ambulatory without an assistive device
- More than anti-gravity strength in major muscle groups as assessed by manual muscle testing
- Medical clearance to participate in an exercise program
- Ability to conform to the requirements of the study (i.e. attendance at assessment and intervention visits, maintain current level of non-study physical activity for the duration of the study, no intention to relocate mid-study)
Key exclusion criteria (9 listed)
- Regular use of an assistive device for mobility (i.e. cane, walker, wheelchair)
- Presence of a pacemaker, metal implants, or other implanted medical devices that could impact participant safety during WB-EMS intervention
- Known pregnancy at the time of screening
- Presence of unstable acute or chronic disease (i.e. renal failure, rheumatologic disease cardia arrhythmia, neoplasm, uncontrolled hypertension)
- Presence of terminal disease (i.e. receiving hospice services)
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 |
|---|---|---|
| ExerciseAlso: Whole-Body Electrical StimulationThe WB-EMS Device is a fitness device that delivers whole-body electrical muscle stimulation in conjunction with exercise programs. After donning a base layer consisting of fitted shorts and shirt, a vest, shorts, and arm straps with integrated electrodes mapped to major muscle groups (biceps, triceps, pectorals, abdominals, periscapular musculature, paraspinal musculature, gluteus musculature, quadriceps, and hamstrings) are donned. The suit connects to an impulse pack that communicates with the Katalyst iPad App to deliver the programmed stimulation to the participant. Within the Katalyst App, there are leveled exercise programs where low levels (i.e. Level 1 and 2) are simple movements and higher levels (i.e. Levels 3, 4, and 5) have more complex and dynamic movements. There is complete user control of the stimulation level of each individual muscle group to tailor to participant responses and tolerance. | Device | Healthy Adults |
Primary outcome
Mean change from baseline in motor unit firing rates of the vastus lateralis using decomposition electromyography (dEMG)
Time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Decomposition electromyography (dEMG) is a measurement of motor unit activity; a surface electrode will be placed over the vastus lateralis in the thigh and participants will be asked to activate that muscle.
Mean change from baseline in central activation ratio of the vastus lateralis using interpolated twitch technique (ITT)
Time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention
The central activation ratio (CAR) is a representation of how completely a person can voluntarily access their maximum force production capacity. Surface electrodes will be placed over the vastus lateralis in the thigh and participants will be asked to activate that muscle.
3 secondary outcomes
Mean change from baseline in mobility testing
Time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Mean change from baseline in balance testing
Time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention
Treatment Feedback Questionnaire
Time frame: Measured within 3 days of completing the intervention
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 6 Nov 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Aging and Sarcopenia, run by University of Missouri-Columbia 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 5 inclusion and 9 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 6 Nov 2026. 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?
Mean change from baseline in motor unit firing rates of the vastus lateralis using decomposition electromyography (dEMG) (time frame: Measured within 3 days of starting the intervention and within 3 days of completing the intervention). The study lists 2 primary outcomes in all. 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 6 Nov 2026.