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| ID | Type | Description | Link |
|---|---|---|---|
| 5I21RX001410-02 | U.S. NIH Grant/Contract | View source |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of care group | No Intervention | SCI individuals receiving conventional rehab | |
| FES-rowing group | Experimental | Individuals with SCI participating in an FES-rowing program |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rowing exercise | Other | Individuals with SCI will use the rowing exerciser to see if there is a benefit to skeletal health in the lower limbs. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Bone Mineral Density | Bone mineral density at the distal femur at 0, 16, 29 and 43 weeks measured using peripheral quantitative computed tomography scanning. | 0, 16, 29 and 43 weeks |
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Inclusion Criteria:
Subjects in the rowing groups:
Subjects in the control group:
Exclusion Criteria:
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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Gary Beaupre, PhD | VA Palo Alto Health Care System, Palo Alto, CA | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California | 94304-1290 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30475172 | Result | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | FES-Rowers | Individuals with complete SCI participating in a 90-session FES-rowing program. |
| FG001 | Standard-of-Care Controls | Individuals with complete SCI undergoing bone density scanning at four time points over 9 months. |
| FG002 | Experienced FES-Rower | An individual with more than 10 years of FES-Rowing experience. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | FES-Rowers | Individuals with complete SCI participating in a 90-session FES-rowing program. |
| BG001 | Standard-of-Care Controls | Individuals with complete SCI undergoing bone density scanning at four time points over 9 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Bone Mineral Density | Bone mineral density at the distal femur at 0, 16, 29 and 43 weeks measured using peripheral quantitative computed tomography scanning. | The only participant in the Stanford-of-Care Control group self-withdrew after 12 weeks of participation, after having a baseline measurement and one other bone density measurement. The participant in the Experienced FES-Rower group was only measured at baseline. | Posted | Mean | Full Range | g/cm^3 | 0, 16, 29 and 43 weeks |
|
1 year
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FES-Rowers | Individuals with complete SCI participating in a 90-session FES-rowing program. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Muscle strain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Muscle strain from hand cycling unrelated to study |
Small number of FES-rowers was due to the time commitment of approximately 138 hours over a 9-12 month period..
Small number of subjects in the Standard-of-Care group was due to the 9-12 month time commitment and the lack of perceived benefits.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Gary S. Beaupre | Department of Veterans Affairs | (650) 493-5000 | 64272 | Gary.Beaupre@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Sep 2, 2015 | Oct 2, 2019 | Prot_SAP_ICF_000.pdf |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D010024 | Osteoporosis |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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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.
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| BG002 | Experienced FES-Rower | An individual with more than 10 years of FES-Rowing experience. |
| BG003 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Baseline Bone Mineral Density | 4% distal femur bone mineral density (g/cm^3) from peripheral quantitative computed tomography scanning | Mean | Full Range | g/cm^3 |
|
| OG002 | Experienced FES-Rower | An individual with more than 10 years of FES-Rowing experience. |
|
|
| 0 |
| 7 |
| 0 |
| 7 |
| 1 |
| 7 |
| EG001 | Standard-of-Care Controls | Individuals with complete SCI undergoing bone density scanning at four time points over 9 months. | 0 | 1 | 0 | 1 | 0 | 1 |
| EG002 | Experienced FES-Rower | An individual with more than 10 years of FES-Rowing experience. | 0 | 1 | 0 | 1 | 0 | 1 |
|
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| D014947 | Wounds and Injuries |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |