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Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury (TEAM-SCI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05597176
Recruitment Status : Recruiting
First Posted : October 27, 2022
Last Update Posted : January 25, 2023
Sponsor:
Information provided by (Responsible Party):
Eduard Tiozzo, PhD, University of Miami

Study Description
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Brief Summary:
The purpose of this research is to test the health benefits of using functional electrical stimulation for lower extremity exercise at home.

Condition or disease Intervention/treatment Phase
Spinal Injuries Other: Spinal Cord Injury Exercise Group Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury (TEAM-SCI)
Actual Study Start Date : January 13, 2023
Estimated Primary Completion Date : December 31, 2024
Estimated Study Completion Date : December 31, 2024

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Spinal Cord Injury Exercise Group
Participants will exercise at home 3-5 times per week under supervision via teleconference. Participants will be part of this group for 18-20 weeks.
 Other: Spinal Cord Injury Exercise Group
Participants will have an initial accommodation period of 4 weeks, during which four 10-minute exercise bouts/day will be interspersed with 5 minutes of rest. The bouts will gradually increase until at least continuous 40-minute sessions. The remaining 12-week intervention will be set at 70% max heart rate for a total of 16 weeks.


Outcome Measures
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Primary Outcome Measures :
  1. Change in percent body fat [ Time Frame: Baseline, 20 weeks (Post Intervention) ]
    Percent body fat will be assessed using Dual Energy x-ray absorbency (DXA)

  2. Change in percent visceral fat [ Time Frame: Baseline, 20 weeks (Post Intervention) ]
    Percent visceral fat will be assessed using DXA

  3. Change in percent of lean body mass [ Time Frame: Baseline, 20 weeks (Post Intervention) ]
    Percent lean body mass will be assessed using DXA

  4. Change in percent of fat free mass [ Time Frame: Baseline, 20 weeks (Post Intervention) ]
    Percent fat free mass will be assessed using DXA


Secondary Outcome Measures :
  1. Change in Lipid Panel values [ Time Frame: Baseline, 20 weeks (Post Intervention) ]
    Lipid panel values including High Density Lipoprotein, Low Density Lipoprotein, Total Cholesterol and triglycerides, all assessed in mg/dL, will be measured from blood samples

  2. Change in resting metabolic rate [ Time Frame: Baseline, 20 weeks (Post Intervention) ]
    Change in resting metabolic rate will be measured by using a large clear plastic dome over the head and the air exhaled will be measured

  3. Change in glucose levels [ Time Frame: Baseline, 20 weeks (Post Intervention) ]
    Glucose will be measured in mg/dL using blood samples

  4. Change in HgbA1C levels [ Time Frame: Baseline, 20 weeks (Post Intervention) ]
    Hemoglobin A1c (HgbA1c) levels will be assessed using blood samples

  5. Change in Insulin levels [ Time Frame: Baseline, 20 weeks (Post Intervention) ]
    Insulin levels will be assessed using blood samples

  6. Change in hsCRP levels [ Time Frame: Baseline, 20 weeks (Post Intervention) ]
    High sensitivity C Reactive Protein (hsCRP) will be assessed using blood samples


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women of child-bearing potential who agree to refrain from getting pregnant during the trial
  • Previously enrolled in the SCIENCE protocol (NCT03495986) randomized to the diet alone group in SCIENCE, and are willing to complete an 8-week (2 month) washout period after the completion of the dietary intervention in the study.

Exclusion Criteria:

  • Do not meet inclusion criteria above
  • Those who have participated in a Functional Electrical Stimulation (FES) or ACE exercise program (>60 minutes/week) within the past 3 months

  • Self-reported or documented history of:

    • orthopedic limitations
    • coronary artery disease
    • type 1 diabetes mellitus; insulin-requiring Type 2 diabetes mellitus; untreated Type 2 diabetes mellitus
    • untreated hypothyroidism
    • renal disease
    • uncontrolled autonomic dysreflexia, recent (within 3 months)
    • deep vein thrombosis (within the past 3 months)
  • On anticoagulation therapy
  • Pressure injuries > Grade II
  • Decisional impairment
  • Prisoners
  • Pregnant or nursing women
  • Any potential causes of autonomic dysreflexia at the discretion of the PI
Contacts and Locations
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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): NCT05597176


Contacts
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Contact: Eduard Tiozzo, PhD 305-243-1633 etiozzo@med.miami.edu

Locations
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United States, Florida
University of Miami Christine E. Lynn Rehabilitation Center Recruiting
Miami, Florida, United States, 33136
Contact: Dinorah Rodriguez, BSN    305-243-2797    drodriguez5@med.miami.edu   
Principal Investigator: Eduard Tiozzo, PhD         
Sponsors and Collaborators
University of Miami
Investigators
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Principal Investigator: Eduard Tiozzo, PhD University of Miami
More Information
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Responsible Party: Eduard Tiozzo, PhD, Research Associate Professor, University of Miami
ClinicalTrials.gov Identifier: NCT05597176    
Other Study ID Numbers: 20220652
First Posted: October 27, 2022    Key Record Dates
Last Update Posted: January 25, 2023
Last Verified: January 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Injuries
Spinal Cord Diseases
 Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Back Injuries