Clinical Trials Logo
NCT number NCT03495986
Study type Interventional
Source Milton S. Hershey Medical Center
Contact
Status Not yet recruiting
Phase N/A
Start date April 2018
Completion date July 2022

Clinical Trial Summary

Evaluate and 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.


Clinical Trial Description

The purpose of this proposal is to evaluate and compare the health benefits of home-based functional electrical stimulation leg cycle ergometry plus diet (HBFESLCE + Diet) to home-based (HB) Diet alone. This is a randomized, baseline-controlled, prospective, interventional trial to assess the impact of a 16-week exercise and/or diet intervention on selected fitness parameters in adults with high SCI. Primary outcome measures will include body composition by iDXA, insulin sensitivity, glucose effectiveness and BMR, while secondary outcomes will include lower extremity BMC and density, lipid profiles, and hsCRP determined before and after the 16-week interventions. Subjects will be randomly assigned to either HBFES LCE + Diet on an RT300 ergometer or Home-based (HB) Diet Alone intervention. Both groups will be routinely monitored via telemedicine while at home.


Study Design


Related Conditions & MeSH terms


See also
  Status Clinical Trial Phase
Recruiting NCT03227575 - Effects of Brisk Walking and Regular Intensity Exercise Interventions on Glycemic Control N/A
Recruiting NCT03241121 - Study of Eating Patterns With a Smartphone App and the Effects of Time Restricted Feeding in the Metabolic Syndrome N/A
Not yet recruiting NCT03259685 - Effect of Non-nutritive Sweeteners of High Sugar Sweetened Beverages on Metabolic Health and Gut Microbiome N/A
Recruiting NCT02743598 - Liraglutide for HIV-associated Neurocognitive Disorder Phase 4
Recruiting NCT02252406 - Impact of Ranolazine in Blood Markers in Women With Angina and Metabolic Syndrome Phase 4
Recruiting NCT02650830 - Seum Bile Acid Profile in Type 2 Diabetes and Association Between Bile Cid Profile and Adipokine or Oxidative Stress N/A
Active, not recruiting NCT02589756 - Fish or Nuts? Dietary Effects on Cardiometabolic Risk Factors and Persistent Organic Pollutants N/A
Active, not recruiting NCT02652975 - Anticancer Treatment of Breast Cancer Related to Cardiotoxicity and Dysfunctional Endothelium N/A
Completed NCT02867215 - Barley Bread and Metabolic Disease N/A
Recruiting NCT02430987 - Prevalence of Metabolic Syndrome in Postmenopause Woman With Hypoactive Sexual Desire Disorder N/A
Active, not recruiting NCT02600338 - Meta-analyses of the Effect of Legumes on Blood Pressure N/A
Completed NCT01911078 - Renal Sympathetic Denervation in Metabolic Syndrome (Metabolic Syndrome Study) N/A
Completed NCT02235805 - Magnesium and Vascular Stiffness N/A
Completed NCT03054779 - Canola Oil Multi-center Intervention Trial II N/A
Recruiting NCT01902654 - Osteoarthritis Cardiovascular Risk Factors N/A
Recruiting NCT01906957 - Cognition and Exercise Training N/A
Withdrawn NCT01839864 - Utilizing a Promotora Model for Rural Adult Hispanics Diagnosed With Metabolic Syndrome: A Clinical Trial N/A
Completed NCT01944579 - Blackberry Flavonoid Absorption and Effects on Intestinal Bacteria N/A
Not yet recruiting NCT01928355 - Cognitive Dysfunction in People Who Are Obese But Metabolically Healthy N/A
Completed NCT01675401 - Body Weight and Vascular Function N/A