Spinal Cord InjuryFES-RNCT02008149
FES Rowing for Skeletal Health After SCI
A study testing Rowing exercise in people with Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.
Trial summary
Following a complete spinal cord injury (SCI), individuals experience progressive bone loss, especially in the legs, with up to 70% of persons with SCI sustaining a fracture at some point during their lifetime. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injury
- What is being tested?
- Rowing exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2014to 4 Dec 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects in the rowing groups:
- male and female SCI outpatients or inpatients
- have a C7 to T12, ASIA-A or ASIA-B, spinal cord injury
- be at least 18 years old
- have their physician's clearance to exercise
- between 3 and 24 months post spinal cord injury*
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- minimum passive hip flexion range of motion (ROM) from 20 to 100 deg
- minimum passive knee flexion ROM from 20 to 100 deg
- minimum passive ankle ROM from +10 deg (dorsi-flexion) to -15 deg (plantar-flexion)
- currently use a manual wheelchair
- be able to perform independent and safe transfers to and from their wheelchair *There is no time post injury restriction for subjects in the experience rower group
- Subjects in the control group:
- male and female SCI outpatients or inpatients
- have a C5 to T12, ASIA-A or ASIA-B, spinal cord injury
- be at least 18 years old
- between 3 and 24 months post spinal cord injury
- be able to perform safe transfers to and from their wheelchair, either independently or with assistance
Who cannot join
- pregnant women
- women of childbearing potential not practicing a reliable method of contraception
- women who are post-menopausal
- have mechanical instability of the spine
- resting blood pressure higher than 140/90
- a grade 1 or greater, sacral, gluteal or ischial pressure ulcer
Show all 22Show fewer
- history of low trauma, lower limb fracture since SCI
- renal disease
- current osteomyelitis
- current thrombosis/hemorrhage
- cancer
- other neurological disease (i.e. stroke, peripheral neuropathy, myopathy)
- any implanted electronic device
- active treatment for epilepsy
- regular use of tobacco
- known coronary artery disease
- family history of sudden cardiac death
- current use of cardioactive medications, e.g., for treatment of congestive heart failure or arrhythmia
- current use of medications that can affect bone density and fracture risk including:
- bisphosphonates
- parathyroid hormone (PTH) and PTH analogs
- androgenic steroids
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
Official title: Using Musculoskeletal Models to Assess FES Rowing for Skeletal Health After SCI
Following a complete spinal cord injury (SCI), individuals experience progressive bone loss, especially in the legs, with up to 70% of persons with SCI sustaining a fracture at some point during their lifetime. Fractures following SCI are costly to treat and more than half of patients experience a medical complication, requiring extended hospitalization, resulting in a substantial impact on their quality of life. To reduce the incidence of fractures, more effective rehabilitation strategies to prevent bone loss are needed. The goal of this research is to determine if bone health can be preserved using an indoor rowing exercise program in which the leg muscles are electrically stimulated using several, small surface electrode pads that are placed on the skin on the front and back thigh muscles. An encouraging case study has recently shown remarkable bone preservation in one individual with SCI who participated in an electrical stimulation rowing program, however, whether other individuals with SCI can achieve the same benefit is currently unknown.
Read the detailed description
In this study the investigators expect to enroll a total of 10 participants with SCI. Five participants will be assigned to a Standard-of-Care (control) group and five participants will be assigned to an FES-rowing intervention group. Group assignment will be partly based on the preference of each potential participant and their willingness to make the necessary time commitment required for participation in a given group, with the added goal, to the extent possible, of matching the two groups for age, gender and time since injury. Only those individuals who have a strong desire to participate in a regular exercise program and who express a willingness to travel to VA Palo Alto the necessary number of times per week to perform FES-rowing will be potential candidates for inclusion in the rowing group.
Bone density measurements for both the Standard-of-Care group and the FES-rowing group will be performed using Dual energy X-ray Absorptiometry (DXA) and peripheral Quantitative Computed Tomography (pQCT). The Standard-of-Care group will undergo no other research procedures.
The muscle conditioning program is accomplished through electrical stimulation of the quadriceps and hamstring muscles using a 4-channel electrical stimulator that applies stimulation using surface electrodes adhered using gel to the skin overlying the quadriceps and hamstrings muscles. The muscle strengthening initially takes place three times per week, sixty minutes per session, progressing up to five sessions per week, for approximately 8 weeks. The muscle strengthening program ensures that subjects have sufficient muscle strength and endurance before they embark on the rowing program. Following the 8-week muscle strengthening program, subjects will begin FES-rowing, with three sessions per week, thirty minutes per session for the following 28 weeks. In the FES-rowing group, the investigators will measure isometric knee extension strength at the start of week 0, and at the end of weeks 12, 24 and 36.
For the rowing group, the investigators will capture 3D kinetics and kinematics in the motion capture laboratory during FES-rowing at the end of weeks 12, 24 and 36. Kinematics during rowing will be collected from fifty passive retro-reflective markers that will be placed on each participant to capture the position and orientation of the 12 interconnected body segments used to represent each subject.
- Conditions
- Spinal Cord Injury
- Being tested
- Rowing exercise
- Keywords
- Osteoporosis
- Medical subject headings
- Spinal Cord Injuries, Osteoporosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rowing exerciseOther
Individuals with SCI will use the rowing exerciser to see if there is a benefit to skeletal health in the lower limbs.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care group | No intervention | SCI individuals receiving conventional rehab |
| FES-rowing group | Experimental | Individuals with SCI participating in an FES-rowing program Receives: Other: Rowing exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone Mineral Density
Bone mineral density at the distal femur at 0, 16, 29 and 43 weeks measured using peripheral quantitative computed tomography scanning.
Measured: 0, 16, 29 and 43 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study start1 Nov 2014
- Primary completion4 Dec 2018
- Study completion4 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Group assignment will be based on the preference of potential subjects. Subjects can either participate in the FES-rowing group or they can participate in the standard-of-care group. The standard-of-care group will not perform FES-rowing; they will only receive periodic bone density measurements over a 36-week period, with a total time commitment of approximately 10 hours. Subjects in the FES-rowing group will participate in rowing sessions requiring a 2 to 3 hour time commitment per week for the duration of the participation.
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Gary Beaupre, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02008149
- Sponsor's protocol ID
- B1410-P
- Other IDs
- 5I21RX001410-02
- Acronym
- FES-R
- Status last verified
- Oct 2019
- First submitted
- 27 Nov 2013
- Last updated
- 25 Oct 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lambach RL, Stafford NE, Kolesar JA, Kiratli BJ, Creasey GH, Gibbons RS, Andrews BJ, Beaupre GS. Bone changes in the lower limbs from participation in an FES rowing exercise program implemented within two years after traumatic spinal cord injury. J Spinal Cord Med. 2020 May;43(3):306-314. doi: 10.1080/10790268.2018.1544879. Epub 2018 Nov 26.
PubMed 30475172
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Musculoskeletal Models to Assess FES Rowing for Skeletal Health After SCI
- ClinicalTrials.gov ID
- NCT02008149
- Acronym / sponsor ID
- FES-R / B1410-P
- Conditions
- Spinal Cord Injury
- Keywords
- Osteoporosis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Nov 2014 (actual)
- Primary completion
- 4 Dec 2018 (actual)
- Study completion
- 4 Dec 2018 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Posted 25 Oct 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Following a complete spinal cord injury (SCI), individuals experience progressive bone loss, especially in the legs, with up to 70% of persons with SCI sustaining a fracture at some point during their lifetime. Fractures following SCI are costly to treat and more than half of patients experience a medical complication, requiring extended hospitalization, resulting in a substantial impact on their quality of life. To reduce the incidence of fractures, more effective rehabilitation strategies to prevent bone loss are needed. The goal of this research is to determine if bone health can be preserved using an indoor rowing exercise program in which the leg muscles are electrically stimulated using several, small surface electrode pads that are placed on the skin on the front and back thigh muscles. An encouraging case study has recently shown remarkable bone preservation in one individual with SCI who participated in an electrical stimulation rowing program, however, whether other individuals with SCI can achieve the same benefit is currently unknown.
Detailed description
In this study the investigators expect to enroll a total of 10 participants with SCI. Five participants will be assigned to a Standard-of-Care (control) group and five participants will be assigned to an FES-rowing intervention group. Group assignment will be partly based on the preference of each potential participant and their willingness to make the necessary time commitment required for participation in a given group, with the added goal, to the extent possible, of matching the two groups for age, gender and time since injury. Only those individuals who have a strong desire to participate in a regular exercise program and who express a willingness to travel to VA Palo Alto the necessary number of times per week to perform FES-rowing will be potential candidates for inclusion in the rowing group.
Bone density measurements for both the Standard-of-Care group and the FES-rowing group will be performed using Dual energy X-ray Absorptiometry (DXA) and peripheral Quantitative Computed Tomography (pQCT). The Standard-of-Care group will undergo no other research procedures.
The muscle conditioning program is accomplished through electrical stimulation of the quadriceps and hamstring muscles using a 4-channel electrical stimulator that applies stimulation using surface electrodes adhered using gel to the skin overlying the quadriceps and hamstrings muscles. The muscle strengthening initially takes place three times per week, sixty minutes per session, progressing up to five sessions per week, for approximately 8 weeks. The muscle strengthening program ensures that subjects have sufficient muscle strength and endurance before they embark on the rowing program. Following the 8-week muscle strengthening program, subjects will begin FES-rowing, with three sessions per week, thirty minutes per session for the following 28 weeks. In the FES-rowing group, the investigators will measure isometric knee extension strength at the start of week 0, and at the end of weeks 12, 24 and 36.
For the rowing group, the investigators will capture 3D kinetics and kinematics in the motion capture laboratory during FES-rowing at the end of weeks 12, 24 and 36. Kinematics during rowing will be collected from fifty passive retro-reflective markers that will be placed on each participant to capture the position and orientation of the 12 interconnected body segments used to represent each subject.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Group assignment will be based on the preference of potential subjects. Subjects can either participate in the FES-rowing group or they can participate in the standard-of-care group. The standard-of-care group will not perform FES-rowing; they will only receive periodic bone density measurements over a 36-week period, with a total time commitment of approximately 10 hours. Subjects in the FES-rowing group will participate in rowing sessions requiring a 2 to 3 hour time commitment per week for the duration of the participation.
| Arm | Type | Receives |
|---|---|---|
| Standard of care group | No intervention | –SCI individuals receiving conventional rehab |
| FES-rowing group | Experimental | Other: Rowing exerciseIndividuals with SCI participating in an FES-rowing program |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- male and female SCI outpatients or inpatients
- have a C7 to T12, ASIA-A or ASIA-B, spinal cord injury
- be at least 18 years old
- have their physician's clearance to exercise
- between 3 and 24 months post spinal cord injury*
Key exclusion criteria (22 listed)
- pregnant women
- women of childbearing potential not practicing a reliable method of contraception
- women who are post-menopausal
- have mechanical instability of the spine
- resting blood pressure higher than 140/90
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 |
|---|---|---|
| Rowing exerciseIndividuals with SCI will use the rowing exerciser to see if there is a benefit to skeletal health in the lower limbs. | Other | FES-rowing group |
Primary outcome
Bone Mineral Density
Time frame: 0, 16, 29 and 43 weeks
Bone mineral density at the distal femur at 0, 16, 29 and 43 weeks measured using peripheral quantitative computed tomography scanning.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30475172Lambach RL, Stafford NE, Kolesar JA, Kiratli BJ, Creasey GH, Gibbons RS, Andrews BJ, Beaupre GS. Bone changes in the lower limbs from participation in an FES rowing exercise program implemented within two years after traumatic spinal cord injury. J Spinal Cord Med. 2020 May;43(3):306-314. doi: 10.1080/10790268.2018.1544879. Epub 2018 Nov 26.
- Individual participant dataSharing planned: No
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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.
Gary Beaupre, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rowing exercise in people with Spinal Cord Injury, run by VA Office of Research and Development at 1 site in United States.
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 17 inclusion and 22 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: finished, as of the sponsor's last update on 25 Oct 2019. 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 United States. 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?
Yes. Results are posted in the registry (first posted 25 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Bone Mineral Density (time frame: 0, 16, 29 and 43 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02008149, which also lists 1 linked publication.
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 25 Oct 2019.