Metabolic Health in Individuals With Spinal Cord Injury (SCI)

NCT03204240 | Completed

• 1 other identifier: 000512788
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Spinal Cord Injury; Skeletal Muscle; Functional Electrical Stimulation; Diabetes

Outcome Measures

Primary Outcomes (3)

• Change in insulin sensitivity

  Liquid meal test will be given and blood samples will be collected before and after meal ingestion.

  Week1 and Week 6 of IPR

• Change in glucose tolerance

  Liquid meal test will be given and blood samples will be collected before and after meal ingestion.

  Week 1 and Week 6 of IPR

• Change in beta cell function

  Liquid meal test will be given and blood samples will be collected before and after meal ingestion.

  Week 1 and Week 6 of IPR

Secondary Outcomes (3)

• Change in metabolic signaling in skeletal muscle

  Week1 and Week 6 of IPR

• Change in muscle strength

  Week 1 and Week 6 of IPR

• Change in muscle fatigue

  Week 1 and Wekk 6 of IPR

Study Arms (2)

Intervention

EXPERIMENTAL

This group will receive electrical stimulation induced exercises in addition to their standard care during in-patient rehabilitation (IPR). Standard care will include respiration therapy, bed mobility, transfers, wheelchair mobility skills, bowel and bladder management, tone and spasticity management, and skills for performing other activities of daily living. Exercises will include neuromuscular electrical stimulation (NMES) induced-resistance exercise (RE) (1x/day) and NMES-aerobic exercise (1x/day) for 3 days/week.

Other: Neuromuscular electrical stimulation

Control

NO INTERVENTION

This group will receive standard care plus passive dynamic exercise of the lower legs (sham treatment for NMES-RE, 1x/day) and transcutaneous electrical nerve stimulation (TENS, sham treatment for NMES-aerobic exercise, 1x/day) during IPR.

Interventions

Neuromuscular electrical stimulation OTHER

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.

Intervention

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• between the ages of 18 and 60 years;
• diagnosis of traumatic SCI at the cervical or thoracic level (C5-T12) classified as AIS A (motor and sensory complete);
• within 14 days of the SCI and the first week of initial inpatient rehabilitation;
• medically stable at the time of testing;
• no history of metabolic syndrome and/or type 1 or type 2 diabetes.

You may not qualify if:

• Pregnant women
• Orthopedic condition that limits lower extremity function
• Neurological (other than SCI), vascular, or cardiac problems that may limit function and interfere with testing procedures
• Have 1 or more contraindications to NMES
• Have lidocaine or iodine allergy

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

UAB

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Muscular Atrophy; Metabolic Diseases; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases

Study Officials

• Ceren Yarar-Fisher, PhD

  OSU

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 14, 2017
• First Posted: June 29, 2017
• Study Start: January 1, 2018
• Primary Completion: August 29, 2022
• Study Completion: August 31, 2022
• Last Updated: March 27, 2023

Record last verified: 2023-03

Locations

US (1)