Telemonitored Exercise to Attenuate Metabolic Dysregulation in Spinal Cord Injury

NCT ID: NCT05597176

Last Updated: 2025-01-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-13
• Study Completion Date: 2025-01-24

Brief Summary

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

Detailed 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.

Conditions

Spinal Injuries

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Spinal Cord Injury Exercise Group

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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.

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Eduard Tiozzo, PhD

Research Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Eduard Tiozzo, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami Christine E. Lynn Rehabilitation Center

Miami, Florida, United States

Countries

United States

Other Identifiers

20220652

Identifier Type: -

Identifier Source: org_study_id