Clinical trial NCT04307017: Fitness Training Using WBEMS Among Individuals With SCI
Official title: Physical Fitness Training Using Whole-Body Electrical Muscle Stimulation Among Individuals Living With Chronic Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Physical Fitness
Whole body electrical muscle stimulation
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Université de Montréal
First posted: 2020-03-13
Enrollment: 1
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

1. 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;
2. be at least one year post-injury (i.e., chronic injury);
3. be between 18 and 65 years of age;
4. be cleared for physical activity based on The Physical Activity Readiness Questionnaire for Everyone (PAR-Q+)34
5. 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)

Primary outcomes:
measure: Duration of Training Session
timeFrame: For the 30 training sessions spread over 10 weeks
measure: Intensity of Training Session
timeFrame: For the 30 training sessions spread over 10 weeks
measure: Adverse Events
timeFrame: For the 30 training sessions spread over 10 weeks, if necessary
Secondary outcomes:
measure: Weight
timeFrame: Up to 10 weeks
measure: Height
timeFrame: Up to 10 weeks
measure: Body Mass Index
timeFrame: Up to 10 weeks
measure: Anthropometric data
timeFrame: Up to 10 weeks
measure: Maximal Isometric Voluntary Strength
timeFrame: Up to 10 weeks
measure: Exercise Self-Efficacy Questionnaire
timeFrame: Up to 10 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: Lyndhurst Centre, Toronto Rehabilitation Institute-UHN
state: Ontario
Study officials:
References: