EMS users in ESRD for Dialysis

N/A

Waitlist Available

Led By Bradley S Dixon, MD

Research Sponsored by Bradley S. Dixon

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, 8 weeks and 16 weeks while exercising, and 4 weeks post exercise

Awards & highlights

No Placebo-Only Group

Summary

The investigators propose a pilot feasibility study to determine if exercise delivered by passive electrical muscle stimulation (EMS) in patients with end stage renal disease (ESRD) on hemodialysis improves physical fitness and insulin resistance, outcome markers associated with morbidity and mortality in this population.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, 8 weeks and 16 weeks while exercising, and 4 weeks post exercise

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, 8 weeks and 16 weeks while exercising, and 4 weeks post exercise

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, 8 weeks and 16 weeks while exercising, and 4 weeks post exercise for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Insulin resistance as measured by the serum Leptin-Adiponectin ratio

Secondary study objectives

Quadriceps muscle strength measured by a belt-stabilized portable dynamometer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: EMS users in ESRDExperimental Treatment1 Intervention

Subjects then initiate passive electrical muscle stimulation (EMS) delivered by a commercially available FDA approved neuromuscular stimulator (EMPI 300PV or its replacement, EMPI Continuum device obtained from EMPI, Inc., St Paul MN) 3 times a week to the quadriceps muscle groups (15 minutes on each side, 30 minutes total) while on hemodialysis. The duration of training will last for 4 months. Subjects will be monitored at regular intervals during the training to make sure they are doing the training correctly and they are not experiencing any problems.

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