Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury

NCT ID: NCT02602639

Last Updated: 2020-06-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

6 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-31

Study Completion Date

2022-09-30

Brief Summary

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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

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Conditions

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Spinal Cord Injury Paraplegia Tetraplegia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Functional electrical stimulation rowing

Using an Odstock 4 channel neuromuscular stimulator with Concept 2 Rower

Group Type EXPERIMENTAL

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

Intervention Type 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.

Interventions

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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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Manitoba

OTHER

Sponsor Role lead

Responsible Party

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Kristine Cowley

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kristine Cowley, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Manitoba

Locations

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University of Manitoba

Winnipeg, Manitoba, Canada

Site Status

Countries

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Canada

Other Identifiers

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H2014:174

Identifier Type: -

Identifier Source: org_study_id

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