Fitness Training Using WBEMS Among Individuals With SCI

NCT04307017 | Completed

• 1 other identifier: 19-5246
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Physical Fitness; Whole body electrical muscle stimulation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (6)

• Weight

  Up to 10 weeks

• Height

  Up to 10 weeks

• Body Mass Index

  Up to 10 weeks

• Anthropometric data

  Up to 10 weeks

• Maximal Isometric Voluntary Strength

  Up to 10 weeks

Interventions

StimaWell®EMS OTHER

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).

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \) 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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Université de Montréal: collaborator

Study Sites (1)

Lyndhurst Centre, Toronto Rehabilitation Institute-UHN

Toronto, Ontario, M4G 3V9, Canada

Location

MeSH Terms

Conditions

Spinal Cord Injuries

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 5, 2020
• First Posted: March 13, 2020
• Study Start: February 1, 2020
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: April 1, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)