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FES Exercise + Diet for Spinal Cord Injury (SCIENCE Trial)
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.
SCIENCE Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSCIENCE Trial Timeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.SCIENCE Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Home-Based Exercise & Diet Group
- Group 2: Home-Based Diet Alone Group
- 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.
Frequently Asked Questions
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."
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."
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."
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."
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."
Who else is applying?
What state do they live in?
How old are they?
What portion of applicants met pre-screening criteria?
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