Spinal Cord InjuryFESNCT02602639
Functional Electrical Stimulation With Rowing as Exercise After Spinal Cord Injury
A study testing Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower) in people with Spinal Cord Injury and Paraplegia, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Spinal Cord Injury, Paraplegia, Tetraplegia
- What is being tested?
- Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteCanada
- Study dates
- Oct 2015to Sep 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Development of a Spinal Cord Injury-specific Exercise-based Capacity
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).
- Conditions
- Spinal Cord Injury, Paraplegia, Tetraplegia
- Being tested
- Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower)
- Medical subject headings
- Spinal Cord Injuries, Paraplegia, Quadriplegia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Functional electrical stimulation rowing | Experimental | Using an Odstock 4 channel neuromuscular stimulator with Concept 2 Rower Receives: Device: Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 24 weeks compared to baseline
Secondary outcomes (2)
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.
Measured: 24 weeks compared to baseline
Leg EMG (electromyogram) while rowing
Participants will perform the rowing exercise while having EMG of multiple leg muscles.
Measured: Throughout study (up to 36 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2015 (estimated)
- Study startOct 2015
- Primary completionDec 2021 (estimated)
- Study completionSep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kristine Cowley, University of Manitoba
- Investigators
- Kristine Cowley, PhD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02602639
- Sponsor's protocol ID
- H2014:174
- Acronym
- FES
- Status last verified
- Jun 2020
- First submitted
- 5 Nov 2015
- Last updated
- 26 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Spinal Cord Injury-specific Exercise-based Capacity
- ClinicalTrials.gov ID
- NCT02602639
- Acronym / sponsor ID
- FES / H2014:174
- Conditions
- Spinal Cord Injury, Paraplegia, Tetraplegia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 11 Nov 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Functional electrical stimulation rowing | Experimental | Device: Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower)Using an Odstock 4 channel neuromuscular stimulator with Concept 2 Rower |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Functional electrical stimulation rowing |
Primary outcome
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.
2 secondary outcomes
Body composition
Time frame: 24 weeks compared to baseline
Leg EMG (electromyogram) while rowing
Time frame: Throughout study (up to 36 weeks)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kristine Cowley, PhD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Functional electrical stimulation rowing (Odstock 4 channel neuromuscular stimulator with Concept 2 Rower) in people with Spinal Cord Injury and Paraplegia, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak VO2 (volume oxygen) output during exercise (time frame: 24 weeks compared to baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2020.