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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 : June 8, 2018
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

April 28, 2017
May 3, 2017
June 8, 2018
August 1, 2015
April 2020   (Final data collection date for primary outcome measure)
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • 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
  • Post-training metabolism: fasting insulin [ Time Frame: 6 months ]
    Change from baseline in fasting insulin, measured via venipuncture and standard laboratory assays
  • Post-training metabolism: fasting glucose [ Time Frame: 6 months ]
    Change from baseline in fasting glucose, measured via venipuncture and standard laboratory assays
  • 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
  • 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
Same as current
Complete list of historical versions of study NCT03139344 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Long Duration Activity and Metabolic Control After Spinal Cord Injury
Long Duration Activity and Metabolic Control After Spinal Cord Injury
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.
Not Provided
Interventional
Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Spinal Cord Injuries
  • 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: Acute gene regulation
    Adaptations in gene regulation in response to single-session low-frequency exercise or high-frequency exercise.
    Interventions:
    • Other: Low-frequency Exercise
    • Other: High-frequency Exercise
  • Experimental: Training study
    Adaptations in gene regulation, systemic metabolic markers, and patient-report metrics in response to training with high-frequency exercise.
    Intervention: Other: High-frequency Exercise

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
96
Same as current
April 2020
April 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
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
United States
 
 
NCT03139344
201503732
R01HD082109 ( U.S. NIH Grant/Contract )
No
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Richard K Shields, University of Iowa
Richard K Shields
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Richard K Shields, PhD, PT University of Iowa
University of Iowa
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP