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

University of Miami

Status: Completed

Conditions: Spinal Injuries

Treatments: Other: Spinal Cord Injury Exercise Group

Study type: Interventional

Funder types: Other

Identifiers

NCT05597176

20220652

Details and patient eligibility

About

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

Full description

The specific objectives are to assess the impact of 16 weeks of home-based telemonitored functional electrical stimulation leg cycle ergometry (FESLCE) exercise on body composition and metabolic health in adults with C4-T4 motor complete SCI. This study is available only to those who were previously enrolled in the SCIENCE protocol #20190659 that were randomized to the diet alone group. After completing the dietary intervention, those individuals will have an opportunity to experience FES bicycle.

Enrollment: 4 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

4 participants in 1 patient group

Spinal Cord Injury Exercise Group

Experimental group

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.

Treatment:

Other: Spinal Cord Injury Exercise Group