N/A
N=9
FES Rowing for Skeletal Health After SCI
Spinal Cord Injury
Bottom Line
View on ClinicalTrials.gov: NCT02008149 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcome: Primary: Bone Mineral Density — 184.0; 174.9; 188.5 g/cm^3
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Rowing exercise (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Bone Mineral Density |
184.0; 174.9; 188.5 | — |
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. 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.
Eligibility Criteria
Inclusion Criteria
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*
- 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
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:
- bisphosphonates
- parathyroid hormone (PTH) and PTH analogs
- androgenic steroids
Data sourced from ClinicalTrials.gov (NCT02008149). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.