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

Primary Purpose

Spinal Cord Injury, Paraplegia, Tetraplegia

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower)
Sponsored by
University of Manitoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Spinal Cord Injury

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Manitoba

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Functional electrical stimulation rowing

Arm Description

Using an Odstock 4 channel neuromuscular stimulator with Concept 2 Rower

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Leg EMG (electromyogram) while rowing
Participants will perform the rowing exercise while having EMG of multiple leg muscles.

Full Information

First Posted
November 5, 2015
Last Updated
June 24, 2020
Sponsor
University of Manitoba
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1. Study Identification

Unique Protocol Identification Number
NCT02602639
Brief Title
Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury
Acronym
FES
Official Title
Development of a Spinal Cord Injury-specific Exercise-based Capacity
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 2015 (Actual)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
September 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Manitoba

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injury, Paraplegia, Tetraplegia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Functional electrical stimulation rowing
Arm Type
Experimental
Arm Description
Using an Odstock 4 channel neuromuscular stimulator with Concept 2 Rower
Intervention Type
Device
Intervention Name(s)
Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower)
Intervention Description
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 Measure Information:
Title
Peak VO2 (volume oxygen) output during exercise
Description
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.
Time Frame
24 weeks compared to baseline
Secondary Outcome Measure Information:
Title
Body composition
Description
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.
Time Frame
24 weeks compared to baseline
Title
Leg EMG (electromyogram) while rowing
Description
Participants will perform the rowing exercise while having EMG of multiple leg muscles.
Time Frame
Throughout study (up to 36 weeks)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kristine Cowley, PhD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba
City
Winnipeg
State/Province
Manitoba
Country
Canada

12. IPD Sharing Statement

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Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury

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