Can electrical leg biking and diet beat metabolic syndrome in spinal cord injury?

NCT ID NCT03495986

Disease control Sponsor: University of Miami Source: ClinicalTrials.gov ↗

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether a home exercise program using electrical stimulation to move the legs, combined with a personalized diet, could improve body composition and metabolism in adults with spinal cord injury. Twenty-six participants were assigned to either exercise plus diet or diet alone for 16 weeks. Researchers measured changes in body fat, lean mass, and insulin sensitivity.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: Functional electrical stimulation leg cycle ergometry and individualized dietary plan
What this could lead to: If successful, this approach could help manage weight and reduce metabolic disease risk in people with spinal cord injury.
What could go wrong: This is a small, completed study with only 26 participants, so results may not apply to everyone. The exercise device and diet plan require significant commitment.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

26 people

The number who actually took part.

Started

Jun 2021

Finished

Jul 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria: * Adults 18-65 years of age (inclusive) * Sex: male or female * Women of child-bearing potential who agree to refrain from getting pregnant during the trial * 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 Exclusion criteria: * \<22% body fat * Unresponsive to neurostimulation * Those who have participated in an FES or ACE exercise program (\>60 minutes/week) within the past 3 months * Known orthopaedic 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 * Decisional impairment * Any potential causes of autonomic dysreflexia at the discretion of the PI * Prisoners * Pregnant or nursing women

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Conditions

The condition(s) this trial relates to.

abdominal obesity-metabolic syndrome metabolic syndrome X Motor Activity paraplegia quadriplegia spinal cord injury

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Dietary modification Metabolic syndrome Paraplegia Spinal cord injuries Tetraplegia

Can electrical leg biking and diet beat metabolic syndrome in spinal cord injury?

What the study statuses mean