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

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ClinicalTrials.gov Identifier: NCT02602639
Recruitment Status : Enrolling by invitation
First Posted : November 11, 2015
Last Update Posted : June 26, 2020
Sponsor:
Information provided by (Responsible Party):
Kristine Cowley, 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).


Condition or disease Intervention/treatment Phase
Spinal Cord Injury Paraplegia Tetraplegia Device: Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Development of a Spinal Cord Injury-specific Exercise-based Capacity
Actual Study Start Date : October 2015
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : September 2022

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Peak VO2 (volume oxygen) output during exercise [ Time Frame: 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 :
  1. Body composition [ Time Frame: 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.

  2. Leg EMG (electromyogram) while rowing [ Time Frame: Throughout study (up to 36 weeks) ]
    Participants will perform the rowing exercise while having EMG of multiple leg muscles.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02602639


Locations
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Canada, Manitoba
University of Manitoba
Winnipeg, Manitoba, Canada
Sponsors and Collaborators
University of Manitoba
Investigators
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Principal Investigator: Kristine Cowley, PhD University of Manitoba
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Responsible Party: Kristine Cowley, Assistant Professor, University of Manitoba
ClinicalTrials.gov Identifier: NCT02602639    
Other Study ID Numbers: H2014:174
First Posted: November 11, 2015    Key Record Dates
Last Update Posted: June 26, 2020
Last Verified: June 2020
Additional relevant MeSH terms:
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Spinal Cord Injuries
Quadriplegia
Paraplegia
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Paralysis
Neurologic Manifestations