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Musculoskeletal Plasticity After Spinal Cord Injury

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ClinicalTrials.gov Identifier: NCT02622295
Recruitment Status : Recruiting
First Posted : December 4, 2015
Last Update Posted : November 29, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

December 2, 2015
December 4, 2015
November 29, 2017
May 2015
January 2020   (Final data collection date for primary outcome measure)
  • Acute gene regulation: MSTN [ Time Frame: 3 hours ]
    Acute post-stimulation effect upon skeletal muscle myostatin (MSTN) 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 receptor gamma coactivator alpha (PGC1-alpha) 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, isozyme 4 (PDK4-alpha) expression, measured via muscle biopsy and exon array analysis
  • Acute gene regulation: SDHB [ Time Frame: 3 hours ]
    Acute post-stimulation effect upon skeletal muscle succinate dehydrogenase-B (SDHB) expression, measured via muscle biopsy and exon array analysis
  • Post-training gene regulation: MSTN [ Time Frame: 16 weeks ]
    Change from baseline in skeletal muscle myostatin (MSTN) expression, measured via muscle biopsy and exon array analysis
  • Post-training gene regulation: PGC1-alpha [ Time Frame: 16 weeks ]
    Change from baseline in skeletal muscle peroxisome proliferator-activated receptor gamma coactivator alpha (PGC1-alpha) expression, measured via muscle biopsy and exon array analysis
  • Post-training gene regulation: PDK4 [ Time Frame: 16 weeks ]
    Change from baseline in skeletal muscle pyruvate dehydrogenase kinase, isozyme 4 (PDK4-alpha) expression, measured via muscle biopsy and exon array analysis
  • Post-training gene regulation: SDHB [ Time Frame: 16 weeks ]
    Change from baseline in skeletal muscle succinate dehydrogenase-B (SDHB) expression, measured via muscle biopsy and exon array analysis
  • Post-training metabolism: fasting glucose [ Time Frame: 16 weeks ]
    Change from baseline in fasting glucose, measured via venipuncture and standard laboratory assays
  • Post-training metabolism: fasting insulin [ Time Frame: 16 weeks ]
    Change from baseline in fasting insulin, measured via venipuncture and standard laboratory assays
  • Post-training metabolism: HOMA score [ Time Frame: 16 weeks ]
    Change from baseline in HOMA score, calculated via the Homeostasis Model Assessement equation
  • Post-training bone turnover: osteocalcin [ Time Frame: 16 weeks ]
    Change from baseline in serum osteocalcin, measured via venipuncture and enzyme-linked immunosorbent assay
Same as current
Complete list of historical versions of study NCT02622295 on ClinicalTrials.gov Archive Site
Post-training subject-report measures: EQ-5D [ Time Frame: 16 weeks ]
Change from baseline in QALY (quality-adjusted life-years) via the EQ-5D subject-report survey instrument
Same as current
Not Provided
Not Provided
 
Musculoskeletal Plasticity After Spinal Cord Injury
Musculoskeletal Plasticity After Spinal Cord Injury
Patients with spinal cord injury (SCI) experience metabolic syndrome, diabetes, obesity, pressure ulcers, and cardiovascular disease at far greater rates than the general population. A rehabilitation method to prevent or reverse the systemic metabolic consequences of SCI is a pressing need. The purpose of this study is to determine the dose of muscle activity that can enhance an oxidative muscle phenotype and improve clinical markers of metabolic health and bone turnover in patients with SCI. The long-term goal of this research is to develop exercise-based interventions to prevent secondary health conditions such as diabetes and to ultimately protect health-related quality of life (QOL). Specific Aim 1: To compare changes in skeletal muscle gene regulation in individuals who receive high frequency (HF) active-resisted stance and low frequency (LF) active-resisted stance for 16 weeks. Hypothesis 1: The expression of genes regulating skeletal muscle metabolism will support that HF and LF both instigate a shift toward an oxidative muscle phenotype. A novel finding will be that LF is a powerful regulator of oxidative pathways in skeletal muscle. Specific Aim 2: To compare changes in systemic markers of metabolic health and bone turnover in individuals with SCI who receive HF or LF for 16 weeks. Hypothesis 2: HF and LF will both reduce glucose/insulin levels and HOMA (homeostasis model assessment) score. However, only HF will demonstrate an effect on bone turnover (higher serum levels of osteocalcin). Secondary Aim: To measure subject-reported QOL using the EQ-5D survey metric. Hypothesis 3: HF and LF subjects will show a trend toward improved self-reported QOL after 16 weeks. There will be an association between metabolic improvement and improved perception of QOL. These observations will support that this intervention has strong feasibility for future clinical translation.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Spinal Cord Injuries
  • Behavioral: Single-session high-frequency active-resisted stance
    In a standing frame or standing wheelchair, the quadriceps and hamstrings will be electrically activated to elicit high muscle forces.
  • Behavioral: Single-session low-frequency active-resisted stance
    In a standing frame or standing wheelchair, the quadriceps and hamstrings will be electrically activated to elicit low muscle forces.
  • Behavioral: High-frequency active-resisted stance training
    In a standing frame or standing wheelchair, the quadriceps and hamstrings will be electrically activated to elicit high muscle forces. Subjects will train for 16 weeks.
  • Behavioral: Low-frequency active-resisted stance training
    In a standing frame or standing wheelchair, the quadriceps and hamstrings will be electrically activated to elicit low muscle forces. Subjects will train for 16 weeks.
  • Experimental: Acute gene regulation
    Adaptations in gene regulation in response to single-session high-frequency active-resisted stance or single-session low-frequency active-resisted stance
    Interventions:
    • Behavioral: Single-session high-frequency active-resisted stance
    • Behavioral: Single-session low-frequency active-resisted stance
  • Experimental: 16 Week Training Study
    Adaptations in gene regulation, metabolic markers, and subject-report metrics in response to 16 weeks of high-frequency active-resisted stance training or 16 weeks of low-frequency active-resisted stance training
    Interventions:
    • Behavioral: High-frequency active-resisted stance training
    • Behavioral: Low-frequency active-resisted stance training

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
80
January 2020
January 2020   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Motor complete SCI (AIS A-B)

Exclusion Criteria:

  1. Pressure ulcers
  2. Chronic infection
  3. Lower extremity muscle contractures
  4. Deep vein thrombosis
  5. Bleeding disorder
  6. Recent limb fractures
  7. Any comorbid disease known to affect bone metabolism (such as parathyroid dysfunction)
  8. Pregnancy
  9. Anti-osteoporosis medications
  10. Vitamin D supplements
  11. Metformin or other medications for diabetes.
Sexes Eligible for Study: All
21 Years to 60 Years   (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
 
 
NCT02622295
200412709
R01HD084645 ( U.S. NIH Grant/Contract )
No
Not Provided
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
November 2017

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