Functional Electrical Stimulation Plus High Intensity Interval Training at Home

N/ANot Yet RecruitingNCT07773974

University Health Network, Toronto24 enrolled

Overview

People living with SCI may experience loss of sensation, movement and regular body function. One way to address these impairments is activity-based therapy (ABT), which includes movement-based activities that promote the muscle-brain connection below the level of injury. A technology often used during ABT is functional electrical stimulation (FES), which is an electrical stimulus applied to nerves or paralyzed muscles through sticky gel pads placed on the skin. The purpose of this multi-method pilot study is to look at the safety, interest in and acceptance of an at-home, virtual training program that combines FES with high intensity interval training (HIIT). Up to 24 individuals with SCI will be enrolled in the study. The study activities will span over 34 weeks, from pre-training tests to the 12-week follow-up tests.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Spinal Cord Injuries (SCI)

Interventions

The FES+HIIT@Home intervention will be 16 weeks in duration. During the first four weeks of the FES+HIIT@Home intervention (i.e., weeks 3-6), participants and caregivers who will be assisting will receive education and hands-on training with FES and HIIT exercises. Each participant will receive a two-channel FES device to keep (i.e., Chattanooga® Continuum). During weeks 7-18, participants will complete 36 online, group-based FES+HIIT@Home sessions (i.e., three 1-hour sessions/week for 12 weeks) that are led by trainers over Microsoft Teams. Sessions will include warm-up exercises (10 minutes), three task-specific exercises (15 minutes/exercise) and cool-down exercises (5 minutes). Each task-specific exercise will be performed in 30-second "all out" bouts with a 1.5-minute rest after each bout.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Be an adult (i.e., ≥18 years old) with a SCI at T12 or above as individuals with a lower motor neuron condition are considered poor candidates for FES. 2. Have a SCI rated as American Spinal Injury Association Impairment Scale A, B, C or D. If no recent (i.e., in past six months) AIS rating is available in the medical record, the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam (Rupp et al. 2021) will be completed by the research team. 3. Be \>1 year post-injury, in the case of traumatic SCI, or \>1 year post-onset of neurological symptoms, in the case of a non-progressive, non-traumatic cause of SCI. 4. Be able to attend 8 assessment sessions and three education sessions at the Lyndhurst Centre or Rumsey Cardiac Rehab, as well as 36 FES+HIIT@Home sessions and one education session on Microsoft Teams. 5. Be ambulatory or use a manual wheelchair. 6. Be able to don/doff electrodes independently or with support from a family member or other caregiver. 7. Have physician clearance to participate in high intensity interval training (i.e., no contraindications to HIIT). 8. Have an emergency contact who can be reached by the research team during FES+HIIT@Home sessions. 9. Able to understand spoken English. Exclusion Criteria: 1. Presents with contraindications to FES (i.e. implanted electronic device, radiation in past six months, active deep vein thrombosis, pregnancy) (Houghton et al. 2010). 2. Presents with cognitive deficits that would prevent independent use of an FES device. 3. Has irritated and/or damaged skin in areas where the electrodes will be applied. 4. Has a cardiovascular morbidity that would limit exercise tolerance, as identified through pre-intervention cardiorespiratory fitness testing (e.g., complex arrhythmias). 5. Participant receives a Botox injection or begins a new therapy or exercise program during the first 20 weeks of the study (i.e., prior to the post-intervention assessments).

Outcomes

Primary Outcomes

Enrollment rates

Number of participants screened per month (plus reasons for exclusion) and the number of participants enrolled per month

Time frame: During enrollment

Adherence

Session attendance (plus reasons for absences) and assessment attendance (plus reasons for omissions)