Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury

Study Overview
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Brief Summary
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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).

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

Conditions
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Spinal Cord Injury, Paraplegia, Tetraplegia

Intervention / Treatment
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* Device: Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Functional electrical stimulation rowing<br>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)<br>* 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.<br>|

What is the study measuring?
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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) |