Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury (FES)

Development of a Spinal Cord Injury-specific Exercise-based Capacity

Currently, those with spinal cord injury (SCI) demonstrate increased prevalence of obesity (75%) cardiovascular disease (30 - 50%), type II diabetes (21%) and osteoporosis in the legs (100%) when compared to the general population. It is important to identify the modes and intensities of exercise most likely to generate a reduction in these inactivity-related diseases in this population.

Therefore, the main purpose of this pilot research project is to implement and test a form of a spinal cord injury-specific exercise, known as FES rowing (FES: functional electrical stimulation).

Study Overview

• Status: Unknown
• Conditions: Spinal Cord Injury; Tetraplegia; Paraplegia
• Intervention / Treatment: Device: Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower)

• Study Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada
      • University of Manitoba

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Have a spinal cord injury, C5-T12 (level), AIS A-D (severity)
• Be aged 18-75 for duration of study
• Medically stable and healthy enough to complete exercise requirements
• Willing and able to complete the at-home training requirements as prescribed
• Willing and able to complete the exercise sessions as prescribed
• Willing and able to complete the VO2 testing throughout the study
• Willing and able to complete the DEXA (Dual-energy X-ray absorptiometry) scans during the study
• Able to understand and follow written or verbal instructions from study staff

Exclusion Criteria:

• Current pressure ulcer(s) at sites of electrical stimulation
• Previous spontaneous or low-impact leg fracture
• Previous diagnosis of cardiovascular disease (ie enlarged heart, heart murmur)
• Unsatisfactory results of EKG (electrocardiogram) screening test
• Known thyroid dysfunction
• Kidney disease
• Cancer
• Blood pressure > 140/90 mmHg
• Currently taking blood pressure medication
• History of epilepsy
• Current hand, arm or shoulder injury
• Current deep vein thrombosis
• Implanted electronic cardiac device (pace maker, defibrillator, etc)
• Ventilator-dependent
• Unable to follow written and verbal instructions

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Functional electrical stimulation rowing; Using an Odstock 4 channel neuromuscular stimulator with Concept 2 Rower

Device: Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower); Participants will strengthen their quadriceps and hamstrings using electrical stimulation for up to 12 weeks (using an Odstock 4 channel neuromuscular stimulator). Then participants will use a seated rower (Concept 2 Rower, fitted with a backrest that allows those with spinal cord injury to engage in rowing) in conjunction with the electrical stimulation for 12-24 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak VO2 (volume oxygen) output during exercise	Peak VO2 testing will be performed before beginning rower training and again at the end of the 24 weeks of training. Testing will be performed with an arm ergometer, rowing without electrical stimulation, and rowing with electrical stimulation. This will assess energy use, time to fatigue, and perceived exertion.	24 weeks compared to baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body composition	Participants will have their body composition (specifically leg percent fat and muscle, and bone mineral density) measured before beginning training and at the end of the 24 weeks of training.	24 weeks compared to baseline
Leg EMG (electromyogram) while rowing	Participants will perform the rowing exercise while having EMG of multiple leg muscles.	Throughout study (up to 36 weeks)

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Kristine Cowley, PhD, University of Manitoba

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2015
• Primary Completion (Anticipated): December 1, 2021
• Study Completion (Anticipated): September 1, 2022

Study Registration Dates

• First Submitted: November 5, 2015
• First Submitted That Met QC Criteria: November 9, 2015
• First Posted (Estimate): November 11, 2015

Study Record Updates

• Last Update Posted (Actual): June 26, 2020
• Last Update Submitted That Met QC Criteria: June 24, 2020
• Last Verified: June 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Trauma, Nervous System; Spinal Cord Diseases; Paralysis; Wounds and Injuries; Spinal Cord Injuries; Quadriplegia; Paraplegia
• Other Study ID Numbers: H2014:174

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No