# Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE)

> **NIH NIH R01** · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · 2021 · $415,063

## Abstract

Project Summary:
Problem: There are an estimated 1.2 million persons in the United States with spinal cord injury (SCI) or
dysfunction and recent literature would imply that more than 2/3 are overweight or obese by BMI standards,
and more than 50% of them are glucose intolerant, with one out of five is frankly diabetic. This special
population already has significant functional deficits including reduced mobility, myocardial atrophy, neurogenic
lung dysfunction, bowel and bladder dysfunction, and a high risk for skin breakdown. The additional deficits of
visual impairment, gastroparesis, renal disease, peripheral polyneuropathy, and impaired wound healing
associated with obesity and diabetes impacts independence to a much greater extent in spinal cord injured
(SCI) than in the able-bodied population. Specific Aims: The specific objectives for the current proposal are
to assess the impact of Home-based functional electrical stimulation leg-cycle exercise HBFES LCE + Diet
versus Diet Alone on (Primary Variables) body composition (%Body Fat, Fat Mass and Fat-Free Mass), insulin
sensitivity(SI), glucose effectiveness (SG), and Basal Metabolic Rate (BMR), as well as (Secondary Variables)
lower extremity bone mineral density (BMD), lipid profiles, and hsCRP in adults with motor complete SCI
between C4-T4. Methods: Forty 18-65 y.o. individuals with C4-T4 motor complete (AIS A&B) spinal cord
injury will be recruited over 48 months to participate in a randomized, baseline-controlled, prospective,
interventional trial to assess the impact of a 16-week telemonitored exercise and/or diet intervention on
selected fitness parameters in adults with SCI. Primary outcome measures will include body composition
assessment, insulin sensitivity, glucose effectiveness and BMR, while secondary outcomes will include BMD,
lipid profiles, and hsCRP determined before and after the 16-week interventions. Subjects will be randomly
assigned to either HBFES LCE plus Diet on an RT300 ergometer (Restorative Therapeutics, Inc., Baltimore,
MD) or Diet Alone intervention as determined by a random number generator. Impact: The potential to
reverse and prevent obesity, diabetes and heart disease in this population has tremendous implications on
quality of life and reduced health care costs. Further, the “side-effects” associated with exercise and diet
intervention, including improved cardiovascular fitness, improved cholesterol profiles, improved functional
mobility, reduced body fat, improved gastric motility, and reduced spasticity will also positively impact the SCI
person's ability to maintain a greater degree of independence and contribute longer to the work force and
society. Home-based telemonitored Exercise and Diet to reduce obesity has tremendous potential, therefore,
to improve health and quality of life, while reducing health care costs for persons with high paraplegia and
tetraplegia.

## Key facts

- **NIH application ID:** 9996746
- **Project number:** 5R01HD091278-04
- **Recipient organization:** UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
- **Principal Investigator:** DAVID R GATER
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $415,063
- **Award type:** 5
- **Project period:** 2017-09-01 → 2022-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9996746

## Citation

> US National Institutes of Health, RePORTER application 9996746, Spinal Cord Injury Exercise and Nutrition Conceptual Engagement (SCIENCE) (5R01HD091278-04). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9996746. Licensed CC0.

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