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Trial record 40 of 293 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

Long Duration Activity and Metabolic Control After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT03139344
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Sponsor:
Collaborator:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Information provided by (Responsible Party):
Richard K Shields, University of Iowa

Brief Summary:
Skeletal muscle is the largest endocrine organ in the body, playing an indispensable role in glucose homeostasis. Spinal cord injury (SCI) prevents skeletal muscle from carrying out this important function. Dysregulation of glucose metabolism precipitates high rates of metabolic syndrome, diabetes, and other secondary health conditions (SHCs) of SCI. These SHCs exert a negative influence on health-related quality of life (HRQOL). New discoveries support that a low level of activity throughout the day offers a more effective metabolic stimulus than brief, episodic exercise bouts. The proposed study will translate this emerging concept to the population of individuals with SCI by using low-force, long-duration electrical muscle stimulation to subsidize daily activity levels. Recently, we demonstrated that this type of stimulation up-regulates key genes that foster an oxidative, insulin-sensitive phenotype in paralyzed muscle. We will now test whether this type of activity can improve glucose homeostasis and metabolic function in patients with chronic paralysis. We hypothesize that improvements in metabolic function will be accompanied by a reduction in SHCs and a concomitant improvement in self-reported HRQOL. The long-term goal of this research is to develop a rehabilitation strategy to protect the musculoskeletal health, metabolic function, and health-related quality of life of people living with complete SCI.

Condition or disease Intervention/treatment
Spinal Cord Injuries Other: Low-frequency Exercise Other: High-frequency Exercise

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Long Duration Activity and Metabolic Control After Spinal Cord Injury
Actual Study Start Date : August 1, 2015
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Acute gene regulation
Adaptations in gene regulation in response to single-session low-frequency exercise or high-frequency exercise.
Other: Low-frequency Exercise
The quadriceps/hamstrings will perform exercise via the application of 1 Hz electrical stimulation.
Other: High-frequency Exercise
The quadriceps/hamstrings will perform exercise via the application of 3 Hz electrical stimulation.
Experimental: Training study
Adaptations in gene regulation, systemic metabolic markers, and patient-report metrics in response to training with high-frequency exercise.
Other: High-frequency Exercise
The quadriceps/hamstrings will perform exercise via the application of 3 Hz electrical stimulation.



Primary Outcome Measures :
  1. Acute gene regulation: NR4A3 [ Time Frame: 3 hours ]
    Acute post-stimulation effect upon skeletal muscle nuclear receptor subfamily 4 group A member 3 (NR4A3) expression, measured via muscle biopsy and exon array analysis

  2. Acute gene regulation: PGC1-alpha [ Time Frame: 3 hours ]
    Acute post-stimulation effect upon skeletal muscle peroxisome proliferator-activated gamma coactivator (PGC1-alpha) expression, measured via muscle biopsy and exon array analysis

  3. Acute gene regulation: ABRA [ Time Frame: 3 hours ]
    Acute post-stimulation effect upon skeletal muscle actin binding Rho activating protein (ABRA) expression, measured via muscle biopsy and exon array analysis

  4. Acute gene regulation: PDK4 [ Time Frame: 3 hours ]
    Acute post-stimulation effect upon skeletal muscle pyruvate dehydrogenase kinase 4 (PDK4) expression, measured via muscle biopsy and exon array analysis

  5. Post-training gene regulation: MYH6 [ Time Frame: 6 months ]
    Change from baseline in skeletal muscle myosin heavy chain 6 (MYH6) expression, measured via muscle biopsy and exon array analysis

  6. Post-training gene regulation: MYL3 [ Time Frame: 6 months ]
    Change from baseline in skeletal muscle myosin light chain 3 (MYL3) expression, measured via muscle biopsy and exon array analysis

  7. Post-training gene regulation: MYH7 [ Time Frame: 6 months ]
    Change from baseline in skeletal muscle myosin heavy chain 7 (MYH7) expression, measured via muscle biopsy and exon array analysis

  8. Post-training gene regulation: ACTN3 [ Time Frame: 6 months ]
    Change from baseline in skeletal muscle actin 3 (ACTN3) expression, measured via muscle biopsy and exon array analysis

  9. Post-training metabolism: fasting insulin [ Time Frame: 6 months ]
    Change from baseline in fasting insulin, measured via venipuncture and standard laboratory assays

  10. Post-training metabolism: fasting glucose [ Time Frame: 6 months ]
    Change from baseline in fasting glucose, measured via venipuncture and standard laboratory assays

  11. Post-training subject-report measures: PROMIS Physical health [ Time Frame: 6 months ]
    Change from baseline in Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health - Physical health T-score

  12. Post-training subject-report measures: PROMIS Mental health [ Time Frame: 6 months ]
    Change from baseline in Patient Reported Outcomes Measurement Information Systems (PROMIS) Global Health - Mental health T-score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Motor complete SCI (AIS A-B)

Exclusion Criteria:

  • Pressure ulcers, chronic infection, lower extremity muscle contractures, deep vein thrombosis, bleeding disorder, recent limb fractures, pregnancy, metformin or other medications for diabetes

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139344


Contacts
Contact: Richard K Shields, PhD, PT 319-335-9791 richard-shields@uiowa.edu
Contact: Shauna Dudley-Javoroski, PhD, PT 319-356-8203 shauna-dudley@uiowa.edu

Locations
United States, Iowa
University of Iowa Recruiting
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
University of Iowa
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
Principal Investigator: Richard K Shields, PhD, PT University of Iowa

Publications:
Responsible Party: Richard K Shields, Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03139344     History of Changes
Other Study ID Numbers: 201503732
R01HD082109 ( U.S. NIH Grant/Contract )
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Richard K Shields, University of Iowa:
metabolism
exercise
glucose
secondary health conditions
quality of life

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