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Trial record 3 of 6 for:    spinal cord injury AND cycling | Open Studies

Skeletal Muscle Hypertrophy and Cardio-Metabolic Benefits After Spinal Cord Injury

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2016 by United States Department of Defense
Sponsor:
Collaborators:
Hunter Holmes McGuire VA Medical Center
Virginia Commonwealth University
James J. Peters Veterans Affairs Medical Center
Information provided by (Responsible Party):
Ashraf S. Gorgey, Department of Defense
ClinicalTrials.gov Identifier:
NCT02660073
First received: December 11, 2015
Last updated: August 1, 2016
Last verified: July 2016
  Purpose

Spinal cord injury (SCI) is a devastating medical problem that affects thousands of civilian and military personnel in the United States. Spinal cord injuries (SCI) predispose individuals to impaired fitness, obesity, glucose intolerance and insulin resistance, placing them at greater risk for diabetes and coronary artery disease. These are devastating problems that occur frequently because of changes in body composition and reduced level of physical activity. Skeletal muscle wasting plays a central role in altered metabolism after SCI. Functional electrical stimulation (FES) is an effective rehabilitation tool that has been used to train the paralyzed skeletal muscles and which has shown some ability to ameliorate the deleterious effects of SCI on metabolism, particularly on insulin sensitivity. However, its ability to reverse skeletal muscle wasting is modest; most studies report limited gains in muscle mass and workload with highly variables outcomes from one study to another. This proposal was stimulated by the findings that a program of neuromuscular electrical stimulation resistance exercise prior to initiating functional electrical stimulation lower extremity cycling (FES-LEC) improves the gains in muscle mass and workload observed with FES. The specific objectives for the current proposal are to compare the impact of FES following evoking skeletal muscle hypertrophy of the lower extremity versus initiating FES cycling without introducing the hypertrophy effects on insulin sensitivity, control of blood sugar levels, oxygen uptake and amounts of muscle tissue and fat deposition. These studies could potentially have significant effects on thousands of people that will experience an SCI in the future as well as those living with SCI where prolonged paralysis is a major quality of life issue.

There is a major need to investigate the mechanisms lead to maximize the benefits of FES applications and to understand cellular or molecular events that are associated with muscle hypertrophy and lead to promoting metabolic health after SCI. The designed study will provide a greater understanding regarding utilization of energy sources (like fats and sugars) in muscle


Condition Intervention
Spinal Cord Injuries
Device: NMES+FES
Device: Control+FES

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Skeletal Muscle Hypertrophy and Cardio-Metabolic Benefits After Spinal Cord Injury

Resource links provided by NLM:


Further study details as provided by United States Department of Defense:

Primary Outcome Measures:
  • Glucose uptake [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    by measuring glucose effectiveness

  • Insulin Sensitivity [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    By performing frequent blood drawing of 32 samples over 3 hour period while the patient is fasting.

  • Oxygen Uptake [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Skeletal Muscle Size [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Magnetic Resonance Imaging

  • Visceral Fat [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Magnetic Resonance Imaging


Other Outcome Measures:
  • Skeletal Muscle protein expressions [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Muscle Biopsy of the Vastus Lateralis Muscle. The Quantity of the Protein will be determined using Western Blot.

  • Mitochondrial Enzyme Activities [ Time Frame: 24 weeks ] [ Designated as safety issue: No ]
    Muscle Biopsy of the Vastus Lateralis Muscle. Mitochondrial enzyme activities will be determined using biochemical assays.


Estimated Enrollment: 48
Study Start Date: October 2015
Estimated Study Completion Date: September 2019
Estimated Primary Completion Date: March 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NMES+FES group
NMES+FES group (n=24; 2 days/week for 24 weeks); this group will undergo twice weekly of 12 weeks of surface NMES and ankle weights followed by 12 additional weeks of twice weekly of progressive FES-LEC using the RT300 bike. The total participation duration is 24 weeks +3 weeks for measurements.
Device: NMES+FES
12 weeks of electrically evoked resistance training followed by 12 weeks of functional electrical stimulation cycling.
Other Name: (NMES; Theratouch)+(FES; RTI300 Bike)
Experimental: Control+FES group
Control+FES group (n=24; 2 days/week for 24 weeks); this group will undergo twice weekly of 12 weeks of passive leg extension/flexion with no ankle weights followed by 12 additional weeks of twice weekly of progressive FES-LEC using the RT300 bike. The total participation duration is 24 weeks+3 weeks for measurements.
Device: Control+FES
12 weeks of passive movement followed by 12 weeks of functional electrical stimulation cycling.
Other Name: Control+(FES; RTI300 Bike)

Detailed Description:

Primary Objectives Aim #1: To determine the impact of 12+12 weeks of neuromuscular electrical stimulation (NMES)+FES-LEC on oxygen uptake, insulin sensitivity and glucose uptake in adults with SCI compared to control + FES-LEC.

Aim #2: To determine the impact of 12+12 weeks of NMES+FES-LEC on skeletal muscle size, infiltration of intramuscular fat, visceral adiposity as well as fatigue resistance compared to control+ FES-LEC.

. Aim #3 : To determine the impact of 12+12 weeks of NMES+FES-LEC on determinants of energy metabolism, protein molecules involved in insulin signaling, muscle hypertrophy and oxygen uptake (IRS-1, adenosine monophosphate kinase (AMPK), glucose transporter (GLUT-4), insulin like growth factor (IGF-1), Akt, mammalian target of rapamycin (mTOR) and Peroxisome proliferator-activated receptor coactivator (PGC-1 alpha) and electron transport chain proteins compared to control + FES-LEC only.

Subjects: Forty eight chronic (1 year or more post-injury) individuals with motor complete SCI will be recruited from the Hunter Holmes McGuire VA Spinal Cord Dysfunction registry and Virginia Commonwealth University over 4 years.

Inclusion Criteria

  1. All participants will be between 18-65 years old, men/women,
  2. greater than one year post SCI,
  3. Body mass index (BMI) < 30 Kg/m2.
  4. Participants must have C5-L2 level of injury, traumatic motor complete or incomplete SCI [American Spinal Injury Impairment Scale Classification (AIS A, B or C)].

Exclusion Criteria:

  1. Participants with any of the following pre-existing medical conditions will be excluded (cardiovascular disease, uncontrolled type II diabetes mellitus, uncontrolled hypertension, and those on insulin, pressures sores stage 3 or greater), hematocrit above 50% or urinary tract infection or symptoms.
  2. Participants with osteoporosis (T-score equal or worse than -2.5 according to the World Health recommendation) will be excluded.
  3. Pregnant women and women who will be involved and become pregnant during the course of the study will be excluded as well.

Study arms

  1. NMES+FES group (n =24; 2 days/week for 24 weeks); this group will undergo twice weekly of 12 weeks of surface NMES and ankle weights followed by 12 additional weeks of twice weekly of progressive FES-LEC using the RT300 bike. The total participation duration is 24 weeks +3 weeks for measurements.
  2. Control + FES group (n =24; 2 days/week for 24 weeks); this group will undergo twice weekly of 12 weeks of passive leg extension/flexion with no ankle weights followed by 12 additional weeks of twice weekly of progressive FES-LEC using the RT300 bike. The total participation duration is 24 weeks+3 weeks for measurements.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • All participants will be between 18-65 years old,
  • men/women,
  • Greater than one year post SCI,
  • with body mass index (BMI) < 30 Kg/m2. .
  • Participants must have traumatic motor complete or incomplete SCI C5-L2 level of injury, American Spinal Injury Impairment Scale Classification (AIS A, B or C).

Exclusion Criteria:

  • Participants with any of the following pre-existing medical conditions will be excluded (cardiovascular disease, uncontrolled type II DM, uncontrolled hypertension, and those on insulin, pressures sores stage 3 or greater), hematocrit above 50% or urinary tract infection or symptoms.
  • Participants with osteoporosis (T-score equal or worse than -2.5 according to the World Health recommendation) will be excluded.
  • Pregnant women and women who will be involved and become pregnant during the course of the study will be excluded as well.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02660073

Locations
United States, New York
James J. Peters VA Medical Center Active, not recruiting
Bronx, New York, United States
United States, Virginia
Hunter Holmes McGuire VA Medical Center Recruiting
Richmond, Virginia, United States, 23249
Contact: Ashraf S Gorgey, MPT,PhD, FACSM    804-675-5000 ext 3386    ashraf.gorgey@va.gov   
Contact: Lance Goetz, MD    804-675-5000 ext 2475    lance.Goetz@va.gov   
Principal Investigator: Ashraf S Gorgey, MPT, PhD, FACSM         
Sub-Investigator: Lance Goetz, MD         
Sub-Investigator: Robert A Adler, MD         
Virginia Commonwealth Unviersity Recruiting
Richmond, Virginia, United States
Contact: William Carter, MD       wcarter@mcvh-vcu.edu   
Contact: Justin O Alicea, CCRP    804-628-1355    joalicea@vcu.edu   
Principal Investigator: William Carter, MD         
Sub-Investigator: Ashraf Gorgey, MPT, PhD, FACSM         
Sub-Investigator: David Cifu         
Sponsors and Collaborators
Ashraf S. Gorgey
Hunter Holmes McGuire VA Medical Center
Virginia Commonwealth University
James J. Peters Veterans Affairs Medical Center
  More Information

Responsible Party: Ashraf S. Gorgey, Director of Research, Department of Defense
ClinicalTrials.gov Identifier: NCT02660073     History of Changes
Other Study ID Numbers: W81XWH-14-SCIRP-CTA 
Study First Received: December 11, 2015
Last Updated: August 1, 2016
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Wounds and Injuries
Spinal Cord Injuries
Hypertrophy
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Pathological Conditions, Anatomical

ClinicalTrials.gov processed this record on December 02, 2016