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- Essai clinique NCT03709095
Sprint Interval Training During Rehabilitation After Spinal Cord Injury (SprintSCI)
15 octobre 2018 mis à jour par: McMaster University
Immediately following a spinal cord injury (SCI), patients are admitted to inpatient rehabilitation where they undergo physical reconditioning in preparation for a return to home setting.
The current standard of practice for aerobic training is performing arm-ergometry for 25 mins at a frequency of three times per week.
Given the move towards shortened length of stay during inpatient rehabilitation, performing MICT can consume a considerable amount of therapy time.
Sprint interval training (SIT) has been shown to elicit similar improvements in physical capacity, despite a reduced time commitment to MICT.
However, there are no controlled trials comparing the effects of SIT to MICT in individuals with SCI undergoing inpatient rehabilitation.
The primary aim of this study was to investigate the efficacy of a five-week, thrice weekly 10 min SIT program and compare outcome measures to a traditional 25 minute MICT program on the arm-ergometer in individuals with SCI undergoing inpatient clinical rehabilitation.
It was hypothesized that five weeks of SIT and MICT would induce similar changes in maximal and sub-maximal exercise performance, self-efficacy for exercise, and exercise enjoyment, despite large differences in training volume and time commitment.
It was also hypothesized that SIT would be well tolerated and elicit higher levels of cardiovascular strain than MICT.
Aperçu de l'étude
Statut
Complété
Les conditions
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
20
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Lieux d'étude
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Ontario
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Hamilton, Ontario, Canada, L8S 4L8
- McMaster University
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 65 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Participants with sub-acute spinal cord injury (time since injury: 14 - 182 days)
- Undergoing inpatient rehabilitation
- Aged 18-65 years
- Injury level at the second cervical vertebrae (C2) or below
Exclusion Criteria:
- Unable to perform arm-ergometry training
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Soins de soutien
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur actif: Moderate Intensity Continuous Training
Training was performed three times a week for five weeks.
Each session began with a 2 minute warm up, and concluded with a 3 minute cool down.
Following the warm-up, participants performed 20 minutes of arm cycling at a self-selected cadence at 45-65% of their peak power output.
Total training duration was 25 mins.
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Participants utilized the arm ergometer for improving aerobic exercise capacity
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Expérimental: Sprint Interval Training
The SIT protocol was adopted from Gillen and colleagues (See Ref), and consisted of 3 x 20 second "all-out" efforts at ≥ 100% of an individuals peak power output.
Each sprint was interspersed by 120 seconds of active recovery at 10% of an individuals peak power output.
Total training duration was 10 mins.
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Participants utilized the arm ergometer for improving aerobic exercise capacity
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Change in peak power output
Délai: Change in peak power output from baseline to 5 weeks
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maximum amount of power produced during a graded exercise test on the arm-ergometer
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Change in peak power output from baseline to 5 weeks
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Change in sub-maximal arm-ergometry
Délai: Change in sub-maximal arm-ergometry from baseline to 5 weeks
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Participants performed three 5-minute steady state workloads on the arm-ergometer at power outputs corresponding to RPE's of 8, 10 and 12. Participants were given a minimum of 2 minutes, and a maximum of 5 minutes of rest in between each workload.
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Change in sub-maximal arm-ergometry from baseline to 5 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Cardiovascular Responses
Délai: Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Monitored heart rate throughout each training session
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Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Perceptual Responses
Délai: Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Monitored ratings of perceived exertion throughout each training session
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Throughout each week of training (Week 1,Week 2, Week 3, Week4, Week 5)
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Change in self-efficacy for exercise
Délai: Change in self-efficacy from baseline to 5 weeks
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Using a self-reported questionnaire, participants rated how confident they are with regards to performing and carrying out regular physical activities and exercises.
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Change in self-efficacy from baseline to 5 weeks
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Exercise Satisfaction
Délai: Measured only at the end of the intervention (5 weeks)
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Participants completed the Physical Activity Enjoyment Scale (PACES) in order to asses the level of enjoyment with the training intervention they received.
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Measured only at the end of the intervention (5 weeks)
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Pain perceptions
Délai: Measured only at the end of the intervention (5 weeks)
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Through a questionnaire, participants rated how much shoulder pain, bodily pain, and physical discomfort they typically experience throughout the day and how much pain they experienced with the intervention they were allocated to.
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Measured only at the end of the intervention (5 weeks)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Audrey L Hicks, PhD, McMaster University
Publications et liens utiles
La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.
Publications générales
- Nightingale TE, Metcalfe RS, Vollaard NB, Bilzon JL. Exercise Guidelines to Promote Cardiometabolic Health in Spinal Cord Injured Humans: Time to Raise the Intensity? Arch Phys Med Rehabil. 2017 Aug;98(8):1693-1704. doi: 10.1016/j.apmr.2016.12.008. Epub 2017 Jan 13.
- Hicks AL, Martin KA, Ditor DS, Latimer AE, Craven C, Bugaresti J, McCartney N. Long-term exercise training in persons with spinal cord injury: effects on strength, arm ergometry performance and psychological well-being. Spinal Cord. 2003 Jan;41(1):34-43. doi: 10.1038/sj.sc.3101389.
- Gillen JB, Martin BJ, MacInnis MJ, Skelly LE, Tarnopolsky MA, Gibala MJ. Twelve Weeks of Sprint Interval Training Improves Indices of Cardiometabolic Health Similar to Traditional Endurance Training despite a Five-Fold Lower Exercise Volume and Time Commitment. PLoS One. 2016 Apr 26;11(4):e0154075. doi: 10.1371/journal.pone.0154075. eCollection 2016.
- Astorino TA, Thum JS. Within-session responses to high-intensity interval training in spinal cord injury. Disabil Rehabil. 2018 Feb;40(4):444-449. doi: 10.1080/09638288.2016.1260648. Epub 2016 Dec 8.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 juin 2017
Achèvement primaire (Réel)
1 juin 2018
Achèvement de l'étude (Réel)
1 juin 2018
Dates d'inscription aux études
Première soumission
11 octobre 2018
Première soumission répondant aux critères de contrôle qualité
15 octobre 2018
Première publication (Réel)
17 octobre 2018
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
17 octobre 2018
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 octobre 2018
Dernière vérification
1 octobre 2018
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- SprintSCI
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .
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