- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07692191
Transcutaneous Spinal Electrical Stimulation to Improve Exercise Function After Spinal Cord Injury.
Our overall objective is to decrease the prevalence of multiple sedentary-related diseases that are secondary consequences of spinal cord injury (SCI). SCI affects motor, sensory and autonomic systems and can cause very limited exercise capacity which then leads to very high rates of obesity, metabolic syndrome, type II diabetes and cardiovascular disease.
This randomized controlled study aims to determine whether and how transcutaneous spinal electrical stimulation (TSES) alters acute (immediate) exercise responses in people living with SCI. Exercise responses will be tested during incremental tests to fatigue, and during steady state tests. Testing will occur over several study visits and results will be compared within each individual as well as between groups (tetraplegia and paraplegia) and to a group of reference controls. A number of outcomes will be monitored, including whole-body metabolic responses using a metabolic cart, muscle responses using EMG sensors and muscle oxygenation using near infrared spectroscopy (NIRS) sensors, time to fatigue, power output, as well as perceptions about fatigue and effort.
The findings of this study are expected to provide evidence regarding whether and how TSES might improve acute exercise responses in people living with SCI.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
It is well understood that SCI causes motor paralysis and sensory loss. However, it is the loss of autonomic regulation that confers the greatest morbidity to those living with SCI. Impaired exercise responses, including limited peak HR, oxygen uptake, limited catecholamine related to impaired activation of spinal sympathetic autonomic systems. Depending upon level of injury, and these sub-optimal exercise responses, there are limited exercise training effects which then leads to a calorie excess and related weight gain, cardiovascular, skeletal muscle and metabolic deconditioning that eventually causes obesity, type II diabetes and cardiovascular disease.
These sedentary-related diseases likely result in large part, because of inadequate activation of these tissues with sufficient duration or intensity to result in training effects. Therefore, we are interested in identifying means to improve acute exercise responses, with an ultimate goal of improving training responses and reducing the incidence of and/or trajectory of developing these sedentary-related diseases in individuals with SCI.
TSES has recently emerged as a potential therapeutic method to improve exercise responses. In case studies it has been shown to increase peak responses and time to fatigue during arm ergometry exercise tests.
This study is designed as a prospective, single-center, randomized controlled trial to examine whether and how TSES might alter exercise responses in two groups of people with SCI (tetraplegia and paraplegia) and a reference control group from the general population. The study is designed to assess within individual and between-group responses for a variety of outcome measures during peak and steady-state exercise tests. Study visits occur over several weeks for each participant, according to each person's time and convenience availability.
Outcomes are assessed during exercise with and without TSES in the following 4 experimental conditions:
- Comparing peak incremental tests to voluntary upper body exercise fatigue with or without TSES.
- Comparing steady state exercise responses performed at 40-45% peak power output with or without TSES.
- Comparing time to fatigue during neuromuscular electrical stimulation (NMES) evoked rhythmic leg contractions with or without TSES.
The primary hypothesis is that TSES will improve a variety of exercise outcomes under different experimental testing conditions and that those with tetraplegia will benefit most.
The results of this study are expected to contribute to whether and how TSES might alter acute exercise responses in those living with SCI.
The results of this study are expected to contribute to the evidence base regarding the effectiveness of TSES to alter peak and steady-state exercise responses in people with SCI and may support its integration into standard exercise training or competitive sport protocols for individuals with SCI.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Kristine C Cowley, PhD
- Numéro de téléphone: +1 204-789-3305
- E-mail: kristine.cowley@umanitoba.ca
Sauvegarde des contacts de l'étude
- Nom: Rodrigo Villar, PhD
- Numéro de téléphone: +1-204-474-8590
- E-mail: rodrigo.villar@umanitoba.ca
Lieux d'étude
-
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 0J9
- Recrutement
- University of Manitoba
-
Contact:
- Kristine Cowley, PhD
- Numéro de téléphone: +1-204-789-3305
- E-mail: kristine.cowley@umanitoba.ca
-
Chercheur principal:
- Kristine Cowley, PhD
-
Chercheur principal:
- Rodrigo Villar, PhD
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
La description
Inclusion Criteria:
- traumatic or non-traumatic spinal cord injury
- Spinal cord injury of at least one year duration, C5 or lower, AIS A - D
- medically stable and healthy enough to engage in and complete exercise requirements
- willing and able to complete the exercise protocols and testing requirements
- able to understand and follow written and verbal instructions from study staff
- able to communicate with study staff about their exercise capabilities and preferences
Exclusion Criteria:
- current serious injury (ies) of the upper extremities
- known cardiovascular disease
- unsatisfactory results of EKG screening
- implanted electronic cardiac devices (e.g., pacemaker, defibrillator, etc.)
- current pressure ulcer(s)
- morbid obesity
- known thyroid dysfunction
- current cancer
- current uncontrolled high blood pressure
- uncontrolled epilepsy
- current deep vein thrombosis
- ventilator dependency
- cognitive impairment
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Science basique
- Répartition: Randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Autre: Upper body exercise in participants with tetraplegia
TSES during peak and steady state exercise in those with tetraplegia
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
|
Autre: Upper body exercise in participants with paraplegia
TSES during peak and steady state exercise in those with paraplegia
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
|
Autre: Upper body exercise in reference control participants
TSES during peak and steady state exercise in reference controls
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
|
Autre: Rhythmic lower limb neuromuscular electrical stimulation evoked exercise
Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise?
|
TSES will typically involve constant current rectangular pulse bipolar stimulation delivered at 20 Hz with stimulation durations of 900 microseconds delivered at or slightly above motor threshold.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Oxygen uptake
Délai: During individual study visits lasting between 1 and 2.5 hours
|
Oxygen uptake, in mL/min
|
During individual study visits lasting between 1 and 2.5 hours
|
|
Perceived Exertion
Délai: Tested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hours
|
Ratings of perceived exertion, on a Borg scale of 6 to 20 with 6 being resting to 20 which is very very hard.
|
Tested intermittently during individual voluntary exercise study visits lasting between 1 and 2.5 hours
|
|
Time to fatigue during incremental exercise tests to fatigue
Délai: Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours.
|
Does TSES alter time to fatigue during NMES-evoked rhythmic lower limb exercise, measured in seconds.
|
Time to fatigue will be monitored during study visits lasting between 1 and 2.5 hours.
|
|
Heart rate
Délai: During exercise testing study visits, lasting between 1 and 3 hours
|
Heart rate, beats per minute
|
During exercise testing study visits, lasting between 1 and 3 hours
|
|
Power output
Délai: During exercise in study visits lasting 1 to 3 hours.
|
Watts
|
During exercise in study visits lasting 1 to 3 hours.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Muscle tissue oxygen saturation levels
Délai: Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.
|
Does TSES alter muscle tissue oxygen saturation levels during exercise, expressed as a percentage.
|
Oxygen saturation levels will be assessed during study visits lasting between 1 and 2.5 hours.
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Kristine Cowley, Phd, University of Manitoba
- Chercheur principal: Rodrigo Villar, PhD, University of Manitoba
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
- Maladies du système nerveux central
- Maladies du système nerveux
- Blessures et Blessures
- Troubles nutritionnels
- Suralimentation
- Poids
- En surpoids
- Traumatisme, système nerveux
- Maladies de la moelle épinière
- Blessures au dos
- Conditions pathologiques, signes et symptômes
- Comportement
- Maladies nutritionnelles et métaboliques
- Signes et symptômes
- Obésité
- Maladies cardiovasculaires
- Blessures à la moelle épinière
- Blessures à la colonne vertébrale
- Activité motrice
Autres numéros d'identification d'étude
- HS26003
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
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