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Metabolic Health in Individuals With Spinal Cord Injury (SCI)

NCT03204240 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-03-27

No results posted yet for this study

Summary

Individuals with spinal cord injury (SCI) live longer than before and live to an age where metabolic disorders become highly prevalent. Due to loss of mobility and severe skeletal muscle atrophy, obesity, glucose intolerance, and peripheral insulin resistance develop soon after the onset of SCI. These abnormalities are thought to contribute to the increased diabetes disease risk and accelerated aging process in the SCI population. As a result of these trends, overall burden of complications, economic impact and reduced quality of life are increasing. Until there are effective treatments for SCI, it is imperative to develop effective interventions to mitigate metabolic disorders that develop in individuals with SCI. The proposed research project examines the impact of early utilization of a novel neuromuscular electrical stimulation (NMES) program on skeletal muscle metabolism and overall metabolic health in individuals with sub-acute, complete SCI.

Conditions

  • Spinal Cord Injuries
  • Skeletal Muscle Atrophy
  • Metabolic Disease

Interventions

OTHER

Neuromuscular electrical stimulation

NMES-RE will involve concentric/eccentric contractions of the quadriceps from a seated position. Briefly, each session will include four sets of 10 actions evoked using 50 Hz trains of 450 µs biphasic pulses. The protocol will be implemented using surface NMES. Upon completion of the NMES-RE session, participants will be given a short break (10-15 minutes) for recovery before starting aerobic training. NMES aerobic exercise will involve twitch electrical stimulation (pulse duration/interval=200/50 µs) applied to the quadriceps muscle via surface NMES. The current amplitude will set to 175 mA. The training will start with 10 minutes of twitch stimulation at 2 Hz. After the first weeks, the duration of the session will progressively increase up to 60 minutes at 10 Hz.

Sponsors & Collaborators

  • Ohio State University

    lead OTHER

Principal Investigators

  • Ceren Yarar-Fisher, PhD · OSU

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-01
Primary Completion
2022-08-29
Completion
2022-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03204240 on ClinicalTrials.gov