Spinal Cord Injury Exercise and Nutrition Conceptual Engagement
NCT ID: NCT03495986
Last Updated: 2025-12-22
Study Results
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View full resultsBasic Information
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COMPLETED
NA
26 participants
INTERVENTIONAL
2021-06-10
2024-07-24
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Home-Based Exercise & Diet Group
16-week home based functional electrical stimulation leg cycle ergometry exercise program and diet intervention
Functional Electrical Stimulation Leg Cycle Ergometry
Exercise training will consist of three to five, 40-67 minute sessions (200 minutes at target intensity) each week for a total of 16 weeks at 70% maximal heart rate; 10-minute warm-up and cool-down sessions will accompany each exercise session.
Diet
An individualized, detailed dietary plan consistent with My Healthy Plate Dietary Guidelines of America will be followed under supervision of Registered Dietitian with weekly telemedicine conferences and monitored dietary intake via MyFitnessPal.
Home-Based Diet Alone Group
Diet intervention
Diet
An individualized, detailed dietary plan consistent with My Healthy Plate Dietary Guidelines of America will be followed under supervision of Registered Dietitian with weekly telemedicine conferences and monitored dietary intake via MyFitnessPal.
Interventions
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Functional Electrical Stimulation Leg Cycle Ergometry
Exercise training will consist of three to five, 40-67 minute sessions (200 minutes at target intensity) each week for a total of 16 weeks at 70% maximal heart rate; 10-minute warm-up and cool-down sessions will accompany each exercise session.
Diet
An individualized, detailed dietary plan consistent with My Healthy Plate Dietary Guidelines of America will be followed under supervision of Registered Dietitian with weekly telemedicine conferences and monitored dietary intake via MyFitnessPal.
Eligibility Criteria
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Inclusion Criteria
* Sex: male or female
* Women of child-bearing potential who agree to refrain from getting pregnant during the trial
* C4-T4 motor complete (AIS A\&B) spinal cord injury for duration greater than 12 months
* \<5% change in body weight over the past 12 months
Exclusion Criteria
* Unresponsive to neurostimulation
* Those who have participated in an FES or ACE exercise program (\>60 minutes/week) within the past 3 months
* Known orthopaedic limitations
* Coronary artery disease
* Type 1 diabetes mellitus, insulin-requiring Type 2 or untreated diabetes mellitus (fasting glucose\>126 or HgbA1c\>7.0)
* Uncompensated Hypothyroidism (Stable on medication \>1 year or not on medication)
* Renal disease
* Uncontrolled autonomic dysreflexia, recent (within 3 months)
* Deep vein thrombosis
* Pressure ulcers \> Grade II
* Decisional impairment
* Any potential causes of autonomic dysreflexia at the discretion of the PI
* Prisoners
* Pregnant or nursing women
18 Years
65 Years
ALL
No
Sponsors
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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
NIH
University of Miami
OTHER
Responsible Party
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Eduard Tiozzo, PhD
Research Assistant Professor
Principal Investigators
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Eduard Tiozzo, PhD, MSCTI
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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6996
Identifier Type: OTHER
Identifier Source: secondary_id
20190659
Identifier Type: -
Identifier Source: org_study_id