Fitness Training Using WBEMS Among Individuals With SCI

Study Overview
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Brief Summary
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Up to 15 individuals living with chronic SCI will be recruited for this study. Each participant will complete an initial clinical assessment before starting a 10-week training program. The training program will consist of three 45-minute Whole-Body Electrical Muscle Stimulation (WBEMS)-augmented exercise training sessions for 10 weeks. At each training session, all adverse events (pain, redness, injury, etc.) will be recorded along with participants' comments concerning comfort (i.e. Objective 1). The investigators hypothesize that the use of a WBEMS will result in no serious adverse effect during and following the training sessions and that it will take less than 10 minutes to don and doff the suit. At the fifth session, after participants have had the opportunity to become familiar with the WBEMS intervention, the immediate effects of the intervention on physiological responses will be assessed (i.e. Objective 2). It is hypothesized that during a single training session consisting of WBEMS and exercise, physiological responses and energy expenditure (EE) will be significantly improved in participants with SCI compared to a training session consisting solely of exercises without WBEMS. At the end of the training program, participants will complete the final clinical assessment to evaluate the therapeutic benefit of the WBEMS-augmented exercise intervention (i.e. Objective 3). Three months after the end of the training program, the participants will be asked to complete a semi-structured interview and questionnaire to evaluate the perceived benefits of the training program (i.e. Objective 3).It is also hypothesized that participants will perceive benefits of the 10-week training program such as decreased spasticity, increased energy and improved mood.

Official Title
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Physical Fitness Training Using Whole-Body Electrical Muscle Stimulation Among Individuals Living With Chronic Spinal Cord Injury

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: StimaWell®EMS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: have a motor complete SCI (i.e., American Spinal Injury Association Impairment Scale grade A or B which means complete motor paralysis below the level of injury) at the neurological level T7 or below (i.e., to avoid triggering autonomic dysreflexia). The participants will have complete motor function of their arms but not of their legs; be at least one year post-injury (i.e., chronic injury); be between 18 and 65 years of age; be cleared for physical activity based on The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)34 be able to provide informed, written consent. Exclusion Criteria: 1) Contraindications for EMS35,36. Electrical stimulation should not be applied: if implanted electronic devices, including cardiac pacemakers if coronary stents are present if cosmetics and other implants are present in the application region to pregnant women on the regions of known or suspected malignancy if active deep vein thrombosis or thrombophlebitis to actively bleeding tissue or to persons with untreated hemorrhagic disorders to infected tissues, tuberculosis, or wounds with underlying osteomyelitis if inflammation is present in the region of application to recently radiated tissues to the chest in persons with cardiac disease, arrhythmias, or heart failure to the neck or head region of persons known to have seizures transcranially without specialized training to areas near reproductive organs or genitalia without specialized training to areas near or over eyes to anterior neck or carotid sinus to damaged or at-risk skin areas that would result in uneven conduction of current (excluding open wounds where the specific intent is to use electrical stimulation for tissue healing)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: StimaWell®EMS|The StimaWell®EMS device is a 12-channel medium-frequency device with modulated low frequency using a high-tech stimulation suit for the trunk and strap electrodes for the arms and legs allowing whole-body stimulation. The device has 70 preprogramed training programs based on goals (e.g., strengthening, endurance training, aerobic training).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of Training Session | Time in minutes | For the 30 training sessions spread over 10 weeks | 
| Intensity of Training Session | Type of activity; repetitions; weight resistance | For the 30 training sessions spread over 10 weeks | 
| Adverse Events | All adverse events, even minor, will be reported in the intervention CRF, and compiled in a specific document (Adverse Event Report Form) all along the study to be analyzed as an outcome of the study | For the 30 training sessions spread over 10 weeks, if necessary | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight |  | Up to 10 weeks | 
| Height |  | Up to 10 weeks | 
| Body Mass Index |  | Up to 10 weeks | 
| Anthropometric data | Circumference of the waist, abdominal region, thighs, legs, arms and forearms | Up to 10 weeks | 
| Maximal Isometric Voluntary Strength | Maximal strength of the major muscle groups of upper extremity (i.e., flexors, extensors and abductors of the shoulder, and flexors and extensors of the elbow) will be measured using hand-held dynamometer | Up to 10 weeks | 
| Exercise Self-Efficacy Questionnaire | Used to assess the perception and confidence to do leisure time physical activity | Up to 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Physical Fitness, Whole body electrical muscle stimulation