Hybrid-FES Exercise to Prevent Cardiovascular Declines in Acute SCI



Status:Recruiting
Conditions:Hospital, Hospital, Orthopedic
Therapuetic Areas:Orthopedics / Podiatry, Other
Healthy:No
Age Range:20 - 40
Updated:6/17/2017
Start Date:December 2013
End Date:September 2019
Contact:Glen Picard, M.A.
Email:gpicard@partners.org
Phone:617-758-5511

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Hybrid-FES Exercise to Prevent Cardiovascualr Declines in Acute SCI

Each year, 11,000 people suffer a spinal cord injury (SCI) in the U.S. Within the first
year, there are profound declines in physiologic function, forming the underlying substrate
for future cardiovascular disease . In fact, acquired cardiovascular disease is an
increasingly recognized consequence of SCI and is the leading cause of death in SCI. Though
incompletely understood, the almost 10-fold prevalence of cardiovascular disease results in
part from profound physiologic 'detraining' resulting from motor impairment and immobility.
Currently, effective interventions preventing acute declines that lead to cardiovascular
compromise and increased risk in SCI are lacking - exercise therapy for those with SCI is
challenging and when employed, is typically limited to the upper body. Recently, the
investigators refined a unique form of exercise for those with SCI that specifically mirrors
exercise performed by those without SCI. Functional Electrical Stimulation (FES) Row
Training (RT) couples volitional arm and electrically controlled leg exercise, resulting in
a hemodynamic profile that produces the beneficial cardiac loading conditions of large
muscle mass exercise. As such, FES-RT may be a safe and effective way to attenuate
cardiovascular declines following SCI. The investigators aims are to test the overall
hypotheses that FES-RT will: 1) mitigate against increased visceral adiposity and reduced
insulin sensitivity, 2) prevent worsening lipid profile and compromised baroreflex function,
and 3) counter ventricular wall thickening and declining ventricular function occurring with
acute SCI, and that these effects will be greater than that observed with an arms-only
exercise group. Changes with FES-RT will be compared to a time (wait-list) control and to
arms-only-RT. Individuals with an SCI within the last 3-6 months will be randomized to
immediate FES-RT, to a time control beginning FES-RT after a 6 month wait, or 6 months of
arms-only-RT followed by FES-RT. Measures will be made at baseline and every 3 months. The
investigators work will provide results that clearly delineate potential health benefits of
FES-RT, and if FES-RT is effective in a majority of those with SCI, its application,
implementation, and integration could be easily replicated.


Inclusion Criteria:

- Spinal cord injured outpatients aged 20-40

- medically stable

- body mass index 18.5-30.0

- 3-6 months post SCI

- ASIA scale A, B or C at neurological level C5-T12

- able to follow directions

- leg muscles responsive to FES

Exclusion Criteria:

- hypertension

- significant arrhythmias

- coronary artery disease

- diabetes

- renal disease

- cancer

- epilepsy

- current use of cardioactive medications

- current grade 2 or greater pressure ulcers at relevant contact sites

- other neurological disease

- peripheral nerve compressions or rotator cuff tears that limit ability to row

- history of bleeding disorder
We found this trial at
1
site
Cambridge, Massachusetts 02138
Principal Investigator: J. Andrew Taylor, Ph.D.
Phone: 617-758-5511
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Cambridge, MA
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