Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury

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Brief Title

Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury

Official Title

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

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).
    



Study Type

Interventional


Primary Outcome

Peak VO2 (volume oxygen) output during exercise

Secondary Outcome

 Body composition

Condition

Spinal Cord Injury

Intervention

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

Study Arms / Comparison Groups

 Functional electrical stimulation rowing
Description:  Using an Odstock 4 channel neuromuscular stimulator with Concept 2 Rower

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

6

Start Date

October 2015

Completion Date

September 2022

Primary Completion Date

December 2021

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
      

Gender

All

Ages

18 Years - 75 Years

Accepts Healthy Volunteers

No

Contacts

Kristine Cowley, PhD, , 

Location Countries

Canada

Location Countries

Canada

Administrative Informations


NCT ID

NCT02602639

Organization ID

H2014:174


Responsible Party

Principal Investigator

Study Sponsor

University of Manitoba


Study Sponsor

Kristine Cowley, PhD, Principal Investigator, University of Manitoba


Verification Date

June 2020