Spinal Cord Injury Exercise and Nutrition Conceptual Engagement
| Status: | Recruiting |
|---|---|
| Conditions: | Hospital, Hospital, Neurology, Orthopedic, Endocrine |
| Therapuetic Areas: | Endocrinology, Neurology, Orthopedics / Podiatry, Other |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 3/7/2019 |
| Start Date: | January 3, 2019 |
| End Date: | July 2022 |
Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)
Evaluate and compare the health benefits of an at home exercise program using functional
electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group
in adults with spinal cord injury.
electrical stimulation (FES) for lower extremity exercise with diet versus a diet alone group
in adults with spinal cord injury.
The purpose of this proposal is to evaluate and compare the health benefits of home-based
functional electrical stimulation leg cycle ergometry plus diet (HBFESLCE + Diet) to
home-based (HB) Diet alone. This is a randomized, baseline-controlled, prospective,
interventional trial to assess the impact of a 16-week exercise and/or diet intervention on
selected fitness parameters in adults with high SCI. Primary outcome measures will include
body composition by iDXA, insulin sensitivity, glucose effectiveness and BMR, while secondary
outcomes will include lower extremity BMC and density, lipid profiles, and hsCRP determined
before and after the 16-week interventions. Subjects will be randomly assigned to either
HBFES LCE + Diet on an RT300 ergometer or Home-based (HB) Diet Alone intervention. Both
groups will be routinely monitored via telemedicine while at home.
functional electrical stimulation leg cycle ergometry plus diet (HBFESLCE + Diet) to
home-based (HB) Diet alone. This is a randomized, baseline-controlled, prospective,
interventional trial to assess the impact of a 16-week exercise and/or diet intervention on
selected fitness parameters in adults with high SCI. Primary outcome measures will include
body composition by iDXA, insulin sensitivity, glucose effectiveness and BMR, while secondary
outcomes will include lower extremity BMC and density, lipid profiles, and hsCRP determined
before and after the 16-week interventions. Subjects will be randomly assigned to either
HBFES LCE + Diet on an RT300 ergometer or Home-based (HB) Diet Alone intervention. Both
groups will be routinely monitored via telemedicine while at home.
Inclusion Criteria:
- C4-T4 motor complete (AIS A&B) spinal cord injury for duration greater than 12 months
- <5% change in body weight over the past 12 months
- Women of child-bearing potential who agree to refrain from getting pregnant during the
trial
- Fluent in written and spoken English
Exclusion Criteria:
- <22% body fat
- Unresponsive to surface neurostimulation
- Those who have participated in an FES or ACE exercise program (>60 minutes/week)
within the past 3 months
- Known orthopedic limitations
- Coronary artery disease
- Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus
(fasting glucose>126 or HgbA1c>7.0)
- Uncompensated hypothyroidism (Stable on medication >1 year or not on medication)
- Renal disease
- Uncontrolled autonomic dysreflexia, recent (within 3 months)
- Deep Vein Thrombosis
- Pressure ulcers > Grade II
- Pregnant or nursing woman
- Decisional impairment
- Prisoner
- Open Wounds
- Any potential causes of autonomic dysreflexia at the discretion of the PI
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