NCT02602639

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 5, 2015

Completed
6 days until next milestone

First Posted

Study publicly available on registry

November 11, 2015

Completed
6.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 26, 2020

Status Verified

June 1, 2020

Enrollment Period

6.2 years

First QC Date

November 5, 2015

Last Update Submit

June 24, 2020

Conditions

Spinal Cord InjuryParaplegiaTetraplegia

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Body composition

    24 weeks compared to baseline

  • Leg EMG (electromyogram) while rowing

    Throughout study (up to 36 weeks)

Study Arms (1)

Functional electrical stimulation rowing

EXPERIMENTAL

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)

Interventions

Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower)DEVICE

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.

Functional electrical stimulation rowing

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Manitoba

Winnipeg, Manitoba, Canada

Location

MeSH Terms

Conditions

Spinal Cord InjuriesParaplegiaQuadriplegia

Condition Hierarchy (Ancestors)

Spinal Cord DiseasesCentral Nervous System DiseasesNervous System DiseasesTrauma, Nervous SystemWounds and InjuriesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Kristine Cowley, PhD

    University of Manitoba

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

November 5, 2015

First Posted

November 11, 2015

Study Start

October 1, 2015

Primary Completion

December 1, 2021

Study Completion

September 1, 2022

Last Updated

June 26, 2020

Record last verified: 2020-06

Locations

CA(1)