Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury

Not Applicable

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

• Registration Number: NCT02602639
• Lead Sponsor: University of Manitoba

Brief Summary

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).

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2015-10
• Study First Submitted: 2015-11-05
• Study First Submitted QC: 2015-11-09
• Study First Posted: 2015-11-11
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-26
• Primary Completion: 2021-12
• Study Completion: 2022-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Functional electrical stimulation rowing	Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower)	Using an Odstock 4 channel neuromuscular stimulator with Concept 2 Rower

Primary Outcome Measures

Name	Time	Method
Peak VO2 (volume oxygen) output during exercise	24 weeks compared to baseline	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.

Secondary Outcome Measures

Name	Time	Method
Leg EMG (electromyogram) while rowing	Throughout study (up to 36 weeks)	Participants will perform the rowing exercise while having EMG of multiple leg muscles.
Body composition	24 weeks compared to baseline	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.

Trial Locations

Locations (1)

University of Manitoba; 🇨🇦 Winnipeg, Manitoba, Canada