FES Rowing for Skeletal Health After SCI

NCT02008149 | Completed Results

• 2 other identifiers: B1410-P5I21RX001410-02
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Spinal Cord Injury

Keywords

Osteoporosis

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Standard of care group

NO INTERVENTION

SCI individuals receiving conventional rehab

FES-rowing group

EXPERIMENTAL

Individuals with SCI participating in an FES-rowing program

Other: Rowing exercise

Interventions

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.

FES-rowing group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Related Publications (1)

• 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.

  PMID: 30475172 RESULT

MeSH Terms

Conditions

Spinal Cord Injuries; Osteoporosis

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Bone Diseases, Metabolic; Bone Diseases; Musculoskeletal Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Gary S. Beaupre
• Organization: Department of Veterans Affairs

Gary.Beaupre@va.gov

(650) 493-5000

Study Officials

• Gary Beaupre, PhD

  VA Palo Alto Health Care System, Palo Alto, CA

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: November 27, 2013
• First Posted: December 11, 2013
• Study Start: November 1, 2014
• Primary Completion: December 4, 2018
• Study Completion: December 4, 2018
• Last Updated: October 25, 2019
• Results First Posted: October 25, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)