FES Cycling With BFR in the Spinal Cord Injury Population
Assessing the Safety and Feasibility of Functional Electrical Stimulation Cycling Coupled With Blood Flow Restriction in a Spinal Cord Injury Population
Cardiometabolic Disease (CMD) is the silent killer within the spinal cord injury/disease (SCI/D) population. Many SCI/D patients' initial CMD presentation is with a heart attack, stroke, or sudden cardiac death, highlighting the need for interventions to reduce CMD risk. CMD contributes to 46% of deaths, with 30-50% of the SCI/D population living with undiagnosed CMD. Treating CMD risk is more challenging in the SCI/D population due to prolonged inactivity, inability to exercise, and excessive caloric intake to expenditure ratio. Identifying accessible and inclusive strategies to combat CMD risk in the SCI/D population is a compelling and urgent health priority.
Blood flow restriction (BFR) exercise involves applying inflatable cuffs to the proximal end of an individual's limbs. Changes to the amount of blood flowing into and out of the limb lead to a low oxygen environment within the limb, shifting the way the muscles can produce the energy required to function, increasing the benefits of low- and moderate-intensity exercise. Coupling BFR with Functional electrical stimulation cycling (FES-cycling), a commonly used rehabilitation tool within the SCI population, could improve FES-cycling's short- and long-term benefits without reducing the accessibility and inclusiveness of long-term exercise prescription. Although preliminary BFR research in the SCI/D has identified positive muscular improvements, whether FES-cycling coupled with BFR can be safely prescribed or feasibly implemented long-term within the SCI/D population is unknown.
The proposed project aims to determine the safety and feasibility of FES-cycling coupled with BFR for 20 minutes of moderate-intensity exercise among adults with chronic spinal cord injury/disease (SCI/D). The research team aims to implement pre-test, eight exercise sessions, and post-test across 6-weeks. Criteria for success include no adverse or severe adverse events not alleviated by ceasing exercise (safety), a 1 to 8 ratio of participants screened to participants eligible (recruitment success), and participants successfully completing all exercise sessions (participant retention).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Background Spinal cord injury/disease (SCI/D) is a highly debilitating condition that results in motor, sensory, autonomic, and autoimmune impairments, which dramatically alters the individual's mobility, life, and health. Following injury, the individual's health is compromised by their primary impairment and secondary health conditions. Cardiometabolic Disease (CMD) refers to a collection of interrelated conditions (e.g., insulin resistance, chronic inflammation, and obesity) that increase the risk of cardiovascular and metabolic disease. CMD disease contributes to 46% of deaths within the SCI/D population. Currently, limited rehabilitation strategies exist that can effectively combat CMD risk factors among individuals living with an SCI/D. Therefore, identifying accessible, inclusive, and safe rehabilitation strategies to combat CMD risk among individuals living with an SCI/D is a compelling and urgent health priority.
Study Aim and Rationale The proposed project aims to investigate the safety and feasibility of functional electrical stimulation cycling (FES-Cycling) coupled with blood flow restriction (BFR). Preliminary studies examining BFR exercise within SCI/D individuals have reported positive findings. However, the pioneering BFR exercise research has not prescribed moderate-intensity aerobic exercise that mirrors the SCI/D weekly exercise guidelines. Therefore, whether BFR can be tolerated safely and practically in the SCI/D population is unknown.
Methods The proposed pilot study will utilize a convergent mixed methods approach and implement a pretest-post test quasi-experimental design. Six adults (18-75yrs) with chronic (>1yr) SCI/D will be recruited to participate in two testing sessions (pre/post), four FES-Cycling exercise sessions, and four FES-cycling coupled with BFR sessions across six weeks. Measures of safety, participant recruitment, and retention will be collected. A criterion of success will be developed for each measure. Descriptive statistics will be calculated and compared to the prior-defined success criterion. Deductive and inductive content analysis will assess participant feedback regarding exercise modality and protocol implementation.
Anticipated Results The research team expects to accomplish the success criteria for all measurement categories based on the existing evidence across the domains of FES-cycling and BFR exercise within SCI/D. Analysis of participant feedback will direct future protocol development and BFR prescription parameters.
Conclusions The proposed project is the first step towards developing a low-cost, highly accessible exercise accessory that could potentially maximize the physiological yield of aerobic and resistance exercise, increasing the potential protective abilities of exercise against CMD risk.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Thomas P Walden, Ph.D
- Número de teléfono: 6287 4165973422
- Correo electrónico: thomas.walden@uhn.ca
Copia de seguridad de contactos de estudio
- Nombre: Katherine Chan, MSc
- Número de teléfono: 6199 4165973422
- Correo electrónico: Katherine.chan@uhn.ca
Ubicaciones de estudio
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Ontario
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Toronto, Ontario, Canadá, M4G 3V9
- Reclutamiento
- Lyndhurst Centre
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Contacto:
- Thomas P Walden, Ph.D
- Número de teléfono: 6287 4165973422
- Correo electrónico: thomas.walden@uhn.ca
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Contacto:
- Katherine Chan, MSc
- Número de teléfono: 6199 4165973422
- Correo electrónico: Katherine.chan@uhn.ca
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Investigador principal:
- B.Catharine Craven, MD
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Sub-Investigador:
- Kristin Musselman, Ph.D
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Adult (≥ 18 to ≤ 75yrs)
- Male or female
- Chronic Injury (>1yr)
- Diagnosis of SCI at levels between C5 to T10 (AIS A-D) with traumatic or non-traumatic etiology.
- ≥3 Cardiometabolic risk parameters
Exclusion Criteria:
- A prior or current history of venous thromboembolism
- Pressure injury of the pelvis, mid to upper thigh region, or foot
- Managing a lower limb fracture
- Any history of embolic stroke
- Myocardial infarction
- Current untreated hypertension
- Language, psychiatric, cognitive, or communicative disability (e.g., traumatic brain injury) that compromises the participant's autonomy to voluntarily join the study, follow its instructions and/or operate the device.
- Current alcohol or street drug use disorder.
- Current use of an anticoagulant medication.
- Frequent episodes of autonomic dysreflexia unresponsive to therapy (e.g., 3-5 times a week).
- Unresolved deep vein thromboembolism (VTE) in the past six months.
- Severe spasticity preventing the necessary range of motion for cycling.
- Active implantable medical device (e.g., pacemaker, ITB pump).
- Inability to provide informed consent.
- Severe active concurrent medical conditions (e.g., skin or respiratory infections, lung, pressure sores).
- Unstable spine or unhealed limbs or pelvic fractures.
- Active heterotopic ossification interfering with the lower extremity range of motion.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: No aleatorizado
- Modelo Intervencionista: Asignación cruzada
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Comparador activo: Functional Electrical Stimulated Cycling
Four FES-Cycling exercise sessions.
Participants will complete 20 minutes of exercise two times a week for 2 weeks.
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Electrical impulses will be sent to the muscles of the lower leg during cycling to facilitate muscular contractions.
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Comparador activo: Functional Electrical Stimulated Cycling with Blood Flow Restriction
Four FES-Cycling with BFR exercise sessions.
Participants will complete 20 minutes of exercise two times a week for 2 weeks.
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Electrical impulses will be sent to the muscles of the lower leg during cycling to facilitate muscular contractions.
Blood Flow Restriction (BFR) exercise is a training method where a specialized cuff or band is applied to the top of a limb (arm or leg) to partially restrict blood flow during exercise.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Participant Retention
Periodo de tiempo: Six weeks - From enrollment to the end of the exercise protocol.
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For a long-term clinical trial spanning 3 to 6 months of data collection per participant, the research team would estimate an approximate retention rate of 80%.
Therefore, our criteria for successful participant retention as a feasibility assessment is having a maximum of two recruited participants who do not complete the 4-week protocol.
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Six weeks - From enrollment to the end of the exercise protocol.
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Safety - Skin Checks
Periodo de tiempo: 6 weeks
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Pre/post-session skin checks will be performed and findings recorded as a metric of safety.
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6 weeks
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Safety - Adverse Event Report
Periodo de tiempo: 6 weeks
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Any adverse or serious adverse events will be reported as per the hospital policy.
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6 weeks
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Recruitment Rate
Periodo de tiempo: 2 to 3 months, depending on how successful the recruitment process is.
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Our criteria for success in recruiting six participants is 2 to 3 months.
The time taken to successfully recruit 6 participants will be reported.
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2 to 3 months, depending on how successful the recruitment process is.
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Change in CMD Risk Profile - Lipid Profile
Periodo de tiempo: Six weeks - From enrollment to the end of the exercise protocol.
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Participants will have a blood draw pre- and post-exercise intervention.
Participants' fasting lipid profiles will be assessed.
All aspects will be reported as millimoles per litre (mmol/L) and will involve: total cholesterol, low-density cholesterol, high-density cholesterol and triglycerides.
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Six weeks - From enrollment to the end of the exercise protocol.
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Participant Perspectives and Experience
Periodo de tiempo: 6 weeks
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Participant satisfaction is fundamental to implementing a successful long-term clinical trial.
The interview guide will use a combination of structured and semi-structured interview techniques during the follow-up session to gain the participant's perspectives on the implemented protocol, elements they enjoy and elements they did not.
After study completion, one-on-one semi-structured interviews (in-person or via MS Teams) lasting approximately 45-60 minutes will be conducted to explore participants' perceptions of recruitment approaches, elements they enjoy and elements they did not.
Interviews will be voiced record and word for word transcribed for batch analysis at the completion of the entire study.
This will allow us to look beyond the efficacy of the novel exercise technique and consider its level of practicality, acceptability and scalability within the SCI population.
Participants that choose to withdraw will not be interviewed.
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6 weeks
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Safety - Heart Rate
Periodo de tiempo: Six weeks - From enrollment to the end of the exercise protocol.
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Heart rate will be measured at fixed time points pre- and post-session and continuously throughout the exercise period.
Heart Rate will be recorded as beats per minute.
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Six weeks - From enrollment to the end of the exercise protocol.
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Safety - Blood Pressure
Periodo de tiempo: Six weeks - From enrollment to the end of the exercise protocol.
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Blood pressure will be recorded at a fixed time point pre- and post-session, and at two-minute increments throughout the exercise period.
Systolic and Diastolic blood pressure will be reported as millimetres of mercury.
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Six weeks - From enrollment to the end of the exercise protocol.
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Safety - Oxygen Saturation
Periodo de tiempo: Six weeks - From enrollment to the end of the exercise protocol.
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Oxygen saturation will be collected at a fixed time point pre- and post-session, and at two-minute increments throughout the exercise period.
Oxygen saturation will be measured as a percentage of available hemoglobin binding sites occupied by oxygen.
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Six weeks - From enrollment to the end of the exercise protocol.
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Safety - Rating of Perceived Exertion and Discomfort.
Periodo de tiempo: Six weeks - From enrollment to the end of the exercise protocol.
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Ratings of perceived exertion and discomfort will be recorded at two-minute increments during the exercise period and at a fixed time point post-exercise.
Both perceived exertion and discomfort will be rated on a scale from 0 to 10.
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Six weeks - From enrollment to the end of the exercise protocol.
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Change in CMD Risk Profile - C-Reactive Protein
Periodo de tiempo: Six weeks - From enrollment to the end of the exercise protocol.
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Participants will have a blood draw pre- and post-exercise intervention.
Participants' C-Reactive Protein levels will be reported as milligrams per litre (mg/L).
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Six weeks - From enrollment to the end of the exercise protocol.
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Change in CMD Risk Profile - Hemoglobin A1c
Periodo de tiempo: Six weeks - From enrollment to the end of the exercise protocol.
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From the Pre-/post-intervention blood draws participant's Hemoglobin A1c will be reported as a percentage (%).
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Six weeks - From enrollment to the end of the exercise protocol.
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Change in CMD Risk Profile - Fasted Plasma Glucose
Periodo de tiempo: Six weeks - From enrollment to the end of the exercise protocol.
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From the pre-/post-intervention blood draws, participants' Fasted Plasma Glucose will be reported as millimoles per litre (mmol/L).
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Six weeks - From enrollment to the end of the exercise protocol.
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Change in CMD Risk Profile - Waist Circumference
Periodo de tiempo: Six weeks - From enrollment to the end of the exercise protocol.
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Pre- and Post-intervention participants' waist circumference will be measured and reported (cm)
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Six weeks - From enrollment to the end of the exercise protocol.
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Change in CMD Risk Profile - Body Mass Index
Periodo de tiempo: Six weeks - From enrollment to the end of the exercise protocol.
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Pre- and Post-intervention participants height (cm) and weight (kg) will be recorded and Body Mass index calculated and reported (kg/m²)
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Six weeks - From enrollment to the end of the exercise protocol.
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades del sistema endocrino
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Heridas y Lesiones
- Trastornos del metabolismo de la glucosa
- Diabetes mellitus
- Trauma, Sistema Nervioso
- Enfermedades de la médula espinal
- Enfermedades Nutricionales y Metabólicas
- Diabetes Mellitus, Tipo 2
- Enfermedades cardiovasculares
- Lesiones de la médula espinal
- Enfermedades metabólicas
- Terapéutica
- Modalidades de fisioterapia
- Atención al paciente
- Terapia de ejercicio
- Rehabilitación
- Cuidado por los convalecientes
- Continuidad de la atención al paciente
- Terapia de restricción de flujo sanguíneo
Otros números de identificación del estudio
- 25-5288
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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