Your session is about to expire
← Back to Search
Behavioral Intervention
FES Exercise + Diet for Spinal Cord Injury (SCIENCE Trial)
N/A
Waitlist Available
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
Must not have
Coronary artery disease
Decisional impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, 21 weeks
Awards & highlights
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.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 18 and 65 years old.
Select...
I have had a complete spinal cord injury above my chest for over a year.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have been diagnosed with coronary artery disease.
Select...
I have difficulty making decisions due to a mental condition.
Select...
I have diabetes that requires insulin or is untreated with high blood sugar levels.
Select...
I have had a deep vein thrombosis.
Select...
My condition did not improve with nerve stimulation therapy.
Select...
I have known issues with my bones or joints.
Select...
I have severe bedsores deeper than just the skin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, 21 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, 21 weeks
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 moreSecondary 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 moreTrial 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
~15070
Find a Location
Who is running the clinical trial?
University of MiamiLead Sponsor
918 Previous Clinical Trials
412,590 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
1,988 Previous Clinical Trials
2,683,484 Total Patients Enrolled
5 Trials studying Metabolic Syndrome
817 Patients Enrolled for Metabolic Syndrome
Eduard Tiozzo, PhD, MSCTIPrincipal InvestigatorUniversity of Miami
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- Any potential reasons for autonomic dysreflexia as decided by the main doctor in charge.I am either male or female.I have been diagnosed with coronary artery disease.My thyroid condition is stable with medication for over a year or I am not on medication.I have kidney disease.I have difficulty making decisions due to a mental condition.I am between 18 and 65 years old.I have had a complete spinal cord injury above my chest for over a year.Your weight has not changed by more than 5% in the last year.I have diabetes that requires insulin or is untreated with high blood sugar levels.You have less than 22% body fat.I have not had uncontrolled autonomic dysreflexia in the last 3 months.I agree not to get pregnant during the trial.You have been in an exercise program for more than an hour a week in the last 3 months.I have had a deep vein thrombosis.My condition did not improve with nerve stimulation therapy.I have known issues with my bones or joints.I have severe bedsores deeper than just the skin.
Research Study Groups:
This trial has the following groups:- Group 1: Home-Based Exercise & Diet Group
- Group 2: Home-Based Diet Alone Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger