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
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Spinal Cord Injuries | Other: Low-frequency Exercise Other: High-frequency Exercise | Not Applicable |
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 |
Arm | Intervention/treatment |
---|---|
Experimental: Acute gene regulation
Adaptations in gene regulation in response to single-session low-frequency exercise or high-frequency exercise.
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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.
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Experimental: Training study
Adaptations in gene regulation, systemic metabolic markers, and patient-report metrics in response to training with high-frequency exercise.
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Other: High-frequency Exercise
The quadriceps/hamstrings will perform exercise via the application of 3 Hz electrical stimulation.
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- 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

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

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
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, Iowa | |
University of Iowa | Recruiting |
Iowa City, Iowa, United States, 52242 |
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 |