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

Primary Purpose

Spinal Injuries

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Spinal Cord Injury Exercise Group
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Spinal Injuries

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami Christine E. Lynn Rehabilitation CenterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Spinal Cord Injury Exercise Group

Arm Description

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.

Outcomes

Primary Outcome Measures

Change in percent body fat
Percent body fat will be assessed using Dual Energy x-ray absorbency (DXA)
Change in percent visceral fat
Percent visceral fat will be assessed using DXA
Change in percent of lean body mass
Percent lean body mass will be assessed using DXA
Change in percent of fat free mass
Percent fat free mass will be assessed using DXA

Secondary Outcome Measures

Change in Lipid Panel values
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
Change in resting metabolic rate
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
Change in glucose levels
Glucose will be measured in mg/dL using blood samples
Change in HgbA1C levels
Hemoglobin A1c (HgbA1c) levels will be assessed using blood samples
Change in Insulin levels
Insulin levels will be assessed using blood samples
Change in hsCRP levels
High sensitivity C Reactive Protein (hsCRP) will be assessed using blood samples

Full Information

First Posted
October 24, 2022
Last Updated
January 23, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05597176
Brief Title
Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury
Acronym
TEAM-SCI
Official Title
Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury (TEAM-SCI)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 13, 2023 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Injuries

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Spinal Cord Injury Exercise Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Spinal Cord Injury Exercise Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in percent body fat
Description
Percent body fat will be assessed using Dual Energy x-ray absorbency (DXA)
Time Frame
Baseline, 20 weeks (Post Intervention)
Title
Change in percent visceral fat
Description
Percent visceral fat will be assessed using DXA
Time Frame
Baseline, 20 weeks (Post Intervention)
Title
Change in percent of lean body mass
Description
Percent lean body mass will be assessed using DXA
Time Frame
Baseline, 20 weeks (Post Intervention)
Title
Change in percent of fat free mass
Description
Percent fat free mass will be assessed using DXA
Time Frame
Baseline, 20 weeks (Post Intervention)
Secondary Outcome Measure Information:
Title
Change in Lipid Panel values
Description
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
Time Frame
Baseline, 20 weeks (Post Intervention)
Title
Change in resting metabolic rate
Description
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
Time Frame
Baseline, 20 weeks (Post Intervention)
Title
Change in glucose levels
Description
Glucose will be measured in mg/dL using blood samples
Time Frame
Baseline, 20 weeks (Post Intervention)
Title
Change in HgbA1C levels
Description
Hemoglobin A1c (HgbA1c) levels will be assessed using blood samples
Time Frame
Baseline, 20 weeks (Post Intervention)
Title
Change in Insulin levels
Description
Insulin levels will be assessed using blood samples
Time Frame
Baseline, 20 weeks (Post Intervention)
Title
Change in hsCRP levels
Description
High sensitivity C Reactive Protein (hsCRP) will be assessed using blood samples
Time Frame
Baseline, 20 weeks (Post Intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eduard Tiozzo, PhD
Phone
305-243-1633
Email
etiozzo@med.miami.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eduard Tiozzo, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Christine E. Lynn Rehabilitation Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dinorah Rodriguez, BSN
Phone
305-243-2797
Email
drodriguez5@med.miami.edu
First Name & Middle Initial & Last Name & Degree
Eduard Tiozzo, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury

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