# Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury

> **NIH NIH R01** · BRIGHAM AND WOMEN'S HOSPITAL · 2022 · $998,300

## Abstract

Over 250,000 Americans are living with paralysis resulting from spinal cord injury (SCI), one of the most
grievous events in a person's life. Inter-linked deficits in multiple physiologic organ systems in persons with SCI
contribute to a vicious cycle of progressively declining musculoskeletal and cardiometabolic health, and
wellbeing. In recognition of the profoundly deleterious effects of chronic SCI on an individual's health, the
National Center for Medical Rehabilitation Research (NCMRR) has deemed “pharmaceutical, stimulation, and
exercise…strategies to improve the motor function and health of SCI patients” a priority area of research. The
NCMRR has further emphasized efficacy trials of multicomponent interventions, as this application proposes to
accomplish. There is evidence - mostly from nonrandomized studies - that arm ergometry and functional
electrical stimulation of the lower extremity during leg cycling (FES-LC) improve physical capacity of SCI
patients. However, the aerobic demands and workloads achieved by arm ergometry or FES-LC alone are often
not of sufficient intensity to induce optimal musculoskeletal and metabolic adaptations. SCI is associated with
high prevalence of androgen deficiency, which further contributes to muscle loss, metabolic dysregulation, and
low mood. By combining FES-LC with concurrent arm ergometry (“hybrid” training), substantially higher levels
of exercise intensity can be achieved than with either intervention alone. The effects of hybrid exercise on
muscle mass, strength, and function are augmented by androgen administration. Furthermore, androgen may
have additional beneficial effects in improving mood, wellbeing, pain sensitivity, and metabolic outcomes.
We hypothesize that a Home-Based Multimodality Functional Recovery and Metabolic Health Enhancement
Program that includes concurrent FES-LC and arm ergometry, and an androgen (19-nortestosterone
decanoate, 19ND) would be more efficacious than arm ergometry alone in improving aerobic capacity, muscle
mass and strength, metabolic health, self-reported function and mobility, and wellbeing. This hypothesis will be
tested in a randomized trial in 84 persons with C7 to T12 SCI, AIS grade A, B or C, 6 months or later after SCI.
Participants will be randomized to either the multi-modality intervention or arm ergometry alone for 16 weeks.
After 2-weeks of training in the exercise laboratory, the intervention will be conducted in the participant's home,
using video monitoring of the home exercise. Primary outcome is peak aerobic capacity. Secondary outcomes
include self-reported function and mobility assessed using computerized adaptive test version of Spinal Cord
Injury-Functional Index; muscle mass, strength and fatigability; fat mass and distribution; metabolism (insulin
sensitivity; lipids; inflammatory markers); wellbeing (mood, anxiety, pain, and life satisfaction). An inter-
disciplinary team, access to a large patient pool, rigorous trial design, assidu...

## Key facts

- **NIH application ID:** 10398790
- **Project number:** 5R01HD093724-05
- **Recipient organization:** BRIGHAM AND WOMEN'S HOSPITAL
- **Principal Investigator:** SHALENDER BHASIN
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $998,300
- **Award type:** 5
- **Project period:** 2018-08-21 → 2024-04-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10398790

## Citation

> US National Institutes of Health, RePORTER application 10398790, Multimodality Intervention to Improve Function and Metabolism in Spinal Cord Injury (5R01HD093724-05). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10398790. Licensed CC0.

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