Hybrid HIIT-FES Cycling Program on Individuals With Spinal Cord Injury to Improve Health

Summary

Project Summary/Abstract Obesity and metabolic syndrome (obesity, dyslipidemia, hyperglycemia, hypertension) are epidemic in the spinal cord injured (SCI) population. A recent study assessing the body composition and metabolic syndrome rates of 72 motor complete chronic SCI individuals revealed an obesity rate of over 90% and a metabolic syndrome rate of 60%. These results are significantly higher than in the general population. As such individuals with SCI typically have systemic inflammation and an accelerated trajectory towards cardiometabolic disease, and early mortality. Although the accelerated trajectory is multi-factorial, substantial evidence implicates sedentary behavior and low physical activity levels as significant contributing factors. Exercise strategies for individuals with SCI have included upper body arm crank exercise (ACE), functional electrical stimulation leg cycling exercise (FES-LCE), or a combination of the two (FES Hybrid Exercise). These modalities have yielded modest improvements in physical fitness and cardiometabolic risk profiles in individuals with SCI. FES-LCE reportedly increased lean-to-fat mass ratio, enhanced peripheral blood flow and vasoreactivity, and increased bone mass in the paralyzed legs. In addition, FES-LCE improves metabolic function as evidenced by increased glucose disposal. There is evidence that high-intensity interval training exercise can increase muscle mass and improve cardiovascular fitness with considerably less time commitment than non-interval activities. However, given many individuals with SCI respond poorly to the onset of training a primer exercise program for the extremely deconditioned muscles is recommended for optimal results. The investigators intend to investigate the optimization of benefits by using a novel hybrid FES cycling protocol (FES legs cycling plus voluntary arms cycling) combined with high intensity interval training (HIIT) and preceded by a preparatory muscle strengthening program called "peripheral remodeling intermittent muscular exercise (PRIME) to prepare the deconditioned muscles for the more intense exercise in the hybrid HIIT-FES cycling program. The investigators hypothesize that individuals in the PRIME + hybrid HIIT-FES cycling program will demonstrate significantly greater cardiometabolic health and functional benefits than the control group receiving standard of care range of motion exercises.

Conditions

• Spinal Cord Injuries

Interventions

OTHER

Muscle strengthening exercise followed by Hybrid FES cycling Exercise

Resistance exercise with arms and electrical stimulation to legs (4 sets of 10 repetitions twice weekly for 4 weeks followed by Hybrid FES cycling which is functional electrical stimulation cycling with the legs and voluntary cycling with the arms for 20-30 minutes twice weekly for 8 weeks.

OTHER

Active ROM exercise with arms and Passive ROM exercise with legs

Active ROM exercise with arms and Passive ROM exercise with legs both 4 sets of 10 repetitions twice weekly

Sponsors & Collaborators

• William Carey University

  lead OTHER

Principal Investigators

• David R Dolbow, DPT, PhD · William Caery University

Study Design

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

21 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-03-03

Primary Completion

2027-08-31

Completion

2027-08-31

Countries

• United States

Study Locations