All > Metabolic Syndrome > Spinal Cord Injury

Functional Electrical Stimulation Leg Cycle Ergometry for Metabolic Syndrome

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
University of Miami, Miami, FLMetabolic Syndrome+4 MoreFunctional Electrical Stimulation Leg Cycle Ergometry - Device
Eligibility
18 - 65
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Metabolic Syndrome
  • Quadriplegia
  • Spinal Cord Injury
  • Paraplegia
  • Dietary Modifications

Treatment Effectiveness

Effectiveness Progress

1 of 3

Similar Trials

1
Conventional early exercise and mobility interventions
1
hybrid exercise
1
Neuromuscular Electrical Stimulation (NMES)

Study Objectives

5 Primary · 4 Secondary · Reporting Duration: Baseline, 21 weeks

Baseline, 21 weeks
Change in Basal Metabolic Rate (BMR)
Change in Fat Mass
Change in Glucose effectiveness (Sg)
Change in High Density Lipoprotein cholesterol (HDL-C) level
Change in High sensitivity C-Reactive Protein (hsCRP) level
Change in Insulin Sensitivity (Si)
Change in Lower Extremity Bone Mineral Density (BMD)
Change in percent Body fat
Cholesterol

Trial Safety

Safety Progress

1 of 3

Similar Trials

1
Conventional early exercise and mobility interventions
2
hybrid exercise
1
Neuromuscular Electrical Stimulation (NMES)

Trial Design

2 Treatment Groups

Home-Based Exercise & Diet Group
1 of 2
Home-Based Diet Alone Group
1 of 2

Experimental Treatment

Non-Treatment Group

60 Total Participants · 2 Treatment Groups

Primary Treatment: Functional Electrical Stimulation Leg Cycle Ergometry · Has Placebo Group · N/A

Home-Based Exercise & Diet GroupExperimental Group · 2 Interventions: Functional Electrical Stimulation Leg Cycle Ergometry, Diet · Intervention Types: Device, Behavioral
Home-Based Diet Alone Group
Behavioral
PlaceboComparator Group · 1 Intervention: Diet · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Diet
2000
Completed Phase 4
~15300

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, 21 weeks

Who is running the clinical trial?

University of MiamiLead Sponsor
806 Previous Clinical Trials
387,056 Total Patients Enrolled
4 Trials studying Metabolic Syndrome
124 Patients Enrolled for Metabolic Syndrome
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,843 Previous Clinical Trials
2,152,744 Total Patients Enrolled
4 Trials studying Metabolic Syndrome
560 Patients Enrolled for Metabolic Syndrome
David Gater, MD, PhD, MSPrincipal Investigator - University of Miami
University of Miami Hospital
University Of Arizona College Of Medicine (Medical School)
University Ca Davis Medical Center (Residency)
1 Previous Clinical Trials
16 Total Patients Enrolled

Eligibility Criteria

Age 18 - 65 · All Participants · 5 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Your weight has not changed by more than 5% in the past year.

Who else is applying?

What state do they live in?
Texas100.0%
How old are they?
18 - 65100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%
References

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer

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

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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