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Trial record 29 of 316 for:    Recruiting, Not yet recruiting, Available Studies | "Spinal Cord Injuries"

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:
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:
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.

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Single-session high-frequency active-resisted stance Behavioral: Single-session low-frequency active-resisted stance Behavioral: High-frequency active-resisted stance training Behavioral: Low-frequency active-resisted stance training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Basic Science
Official Title: Musculoskeletal Plasticity After Spinal Cord Injury
Actual Study Start Date : May 2015
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
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.

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
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.




Primary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. Post-training metabolism: fasting glucose [ Time Frame: 16 weeks ]
    Change from baseline in fasting glucose, measured via venipuncture and standard laboratory assays

  10. Post-training metabolism: fasting insulin [ Time Frame: 16 weeks ]
    Change from baseline in fasting insulin, measured via venipuncture and standard laboratory assays

  11. Post-training metabolism: HOMA score [ Time Frame: 16 weeks ]
    Change from baseline in HOMA score, calculated via the Homeostasis Model Assessement equation

  12. Post-training bone turnover: osteocalcin [ Time Frame: 16 weeks ]
    Change from baseline in serum osteocalcin, measured via venipuncture and enzyme-linked immunosorbent assay


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

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): NCT02622295


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
Richard K Shields
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: NCT02622295     History of Changes
Other Study ID Numbers: 200412709
R01HD084645 ( U.S. NIH Grant/Contract )
First Posted: December 4, 2015    Key Record Dates
Last Update Posted: November 29, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Richard K Shields, University of Iowa:
metabolism
glucose
osteoporosis
secondary health conditions
quality of life
standing
electrical stimulation
diabetes
insulin
skeletal muscle

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