Effects of Whole-body Electrical Muscle Stimulation Exercise on Spinal Motoneuronal Activation in Older Adults

NCT06689618 | Recruiting FDA Device

• 1 other identifier: 2116666
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Sarcopenia; Aging; Sarcopenia in Elderly

Keywords

Aging; Motoneuronal Activation; Electrical Stimulation; Whole-Body Stimulation; Sarcopenia; Exercise Intervention; Exercise

Outcome Measures

Primary Outcomes (2)

• 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 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 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

  Measured within 3 days of starting the intervention and within 3 days of completing the intervention

• Mean change from baseline in balance testing

  Measured within 3 days of starting the intervention and within 3 days of completing the intervention

• Treatment Feedback Questionnaire

  Measured within 3 days of completing the intervention

Study Arms (1)

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).

Device: Exercise

Interventions

Exercise DEVICE

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.

Also known as: Whole-Body Electrical Stimulation

Healthy Adults

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

NextGen Precision Health Building, Clinical and Translational Science Unit

Columbia, Missouri, 65211, United States

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Motor Activity

Interventions

Exercise Therapy

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Central Study Contacts

Kristina Kelly, DPT, MS

CONTACT

5738842596; kristina.kelly@health.missouri.edu

W. David Arnold, MD

CONTACT

Study Design

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

Model Details: 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.

Study Record Dates

• First Submitted: November 13, 2024
• First Posted: November 14, 2024
• Study Start: August 18, 2025
• Primary Completion: May 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)