Functional Electrical Stimulation Leg Cycle Ergometry for Metabolic Syndrome
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.
- Metabolic Syndrome
- Spinal Cord Injury
- Dietary Modifications
5 Primary · 4 Secondary · Reporting Duration: Baseline, 21 weeks
2 Treatment Groups
Home-Based Exercise & Diet Group
1 of 2
Home-Based Diet Alone Group
1 of 2
60 Total Participants · 2 Treatment Groups
Primary Treatment: Functional Electrical Stimulation Leg Cycle Ergometry · Has Placebo Group · N/A
Who is running the clinical trial?
Age 18 - 65 · All Participants · 5 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
Who else is applying?
What state do they live in?
How old are they?
|18 - 65||100.0%|
What portion of applicants met pre-screening criteria?
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor