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Behavioral Intervention

FES Exercise + Diet for Spinal Cord Injury (SCIENCE Trial)

N/A
Recruiting
Led By Eduard Tiozzo, PhD, MSCTI
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Adults 18-65 years of age (inclusive)
C4-T4 motor complete (AIS A&B) spinal cord injury for duration greater than 12 months
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 21 weeks
Awards & highlights

SCIENCE Trial Summary

This trial will 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.

Who is the study for?
Adults aged 18-65 with a stable body weight and C4-T4 motor complete spinal cord injury for over a year can join. They must not be pregnant, have severe diabetes, kidney disease, recent heart issues, or pressure sores above Grade II. Participation in similar exercise programs in the last 3 months is also disqualifying.Check my eligibility
What is being tested?
The trial tests an at-home health program combining leg exercises using electrical stimulation (FES) with dietary changes against just diet modifications alone to see which is more beneficial for adults with spinal cord injuries.See study design
What are the potential side effects?
Possible side effects may include skin irritation from electrodes used in FES, muscle fatigue or soreness from exercise, and digestive changes due to new diets. The severity of these side effects will vary among participants.

SCIENCE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have had a complete spinal cord injury above my chest for over a year.

SCIENCE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 21 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 21 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in Basal Metabolic Rate (BMR)
Change in Fat Mass
Change in Glucose effectiveness (Sg)
+2 more
Secondary outcome measures
Change in High Density Lipoprotein cholesterol (HDL-C) level
Change in High sensitivity C-Reactive Protein (hsCRP) level
Change in Lower Extremity Bone Mineral Density (BMD)
+1 more

SCIENCE Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Home-Based Exercise & Diet GroupExperimental Treatment2 Interventions
16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention
Group II: Home-Based Diet Alone GroupPlacebo Group1 Intervention
Diet intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diet
2000
Completed Phase 4
~15300

Find a Location

Who is running the clinical trial?

University of MiamiLead Sponsor
901 Previous Clinical Trials
409,926 Total Patients Enrolled
5 Trials studying Metabolic Syndrome
374 Patients Enrolled for Metabolic Syndrome
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,964 Previous Clinical Trials
2,674,670 Total Patients Enrolled
5 Trials studying Metabolic Syndrome
817 Patients Enrolled for Metabolic Syndrome
Eduard Tiozzo, PhD, MSCTIPrincipal InvestigatorUniversity of Miami

Media Library

Diet (Behavioral Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT03495986 — N/A
Metabolic Syndrome Research Study Groups: Home-Based Exercise & Diet Group, Home-Based Diet Alone Group
Metabolic Syndrome Clinical Trial 2023: Diet Highlights & Side Effects. Trial Name: NCT03495986 — N/A
Diet (Behavioral Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03495986 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are engaging in this experiment?

"Correct. The records hosted on clinicaltrials.gov demonstrate that this medical investigation, which was originally published on June 10th 2021, is still within its recruitment phase. Approximately 60 persons need to be accepted from a single site in order for the trial to continue."

Answered by AI

Are there still opportunities for patients to participate in this trial?

"Affirmative. The records available on clinicaltrials.gov demonstrate that this experiment is open for recruitment and commenced June 10, 2021 before being updated most recently May 23, 2022. Sixty participants are needed to partake in the research at a single site."

Answered by AI

Does the protocol for this research study permit participants below 30 years of age?

"The age range that is eligible for inclusion in this trial ranges from 18 to 65 years old."

Answered by AI

What are the primary aims of this experiment?

"This trial is primarily assessing the alteration of fat masses over a period of 21 weeks from baseline. Additionally, hsCRP levels in blood serum samples, Lower Extremity Bone Mineral Density (BMD) via DXA scans and High Density Lipoprotein cholesterol concentrations are also being evaluated for any changes."

Answered by AI

What criteria must be met to participate in this trial?

"For this medical trial, 60 individuals aged between 18 and 65 with metabolic syndrome are being accepted. Additionally, applicants must have not experienced a greater than 5% body weight fluctuation over the past year along with matching the specified gender demographic or agreeing to refrain from getting pregnant during the duration of the study."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Met criteria
~2 spots leftby May 2024