- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT03143582
Examining the Effects of a Team-based Running Program
18 avril 2020 mis à jour par: Juliana Tobon, St. Joseph's Healthcare Hamilton
Examining the Effects of a Team-based Running Program on the Mental Health and Cognition of Emerging Adults: A Pilot Study
The investigators are interested in finding accessible interventions for youth and young adults that help promote long-term positive mental health functioning.
They will be investigating the effects of Team Unbreakable, a 13-week, twice weekly running group, on mental health symptoms, memory, and attention.
This intervention will hopefully improve mental health functioning in youth aged 17-25 that are at high risk of developing mental health disorders.
Sessions will consist of 30 minutes of running under the supervision of group leaders and coaches.
The group will steadily increase the distance and time spent running versus walking, with the goal of having everyone run a 5 km race together at the end of 13 weeks.
Once a week, youth will be provided with education on a variety of topics related to health and running.
Youth will complete measures before, during, and after the program to assess outcomes.
Aperçu de l'étude
Statut
Complété
Intervention / Traitement
Type d'étude
Interventionnel
Inscription (Réel)
30
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, L8P 4W6
- Youth Wellness Centre
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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
17 ans à 25 ans (Enfant, Adulte)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- Healthy enough to participate in physical activity
Exclusion Criteria:
- NOT excluded on basis of mental health or addiction concerns
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: Autre
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Running group
13 week, bi-weekly running group
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A 13-week running program where youth run for 30 minutes twice weekly.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Patient Health Questionnaire 9 (PHQ-9)
Délai: Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group.
|
Nine-item self-report measure designed to monitor the severity of depressive symptoms using the diagnostic criteria found in the DSM-IV
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Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group.
|
|
Generalized Anxiety Disorder 7 (GAD-7)
Délai: Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group.
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Seven-item self-report anxiety questionnaire designed to monitor and assess the severity of generalized anxiety disorder (GAD) symptoms, using the prominent diagnostic features found in the DSM-IV
|
Starting 1 month to 2 weeks prior to group. Administered on a bi-weekly schedule ending 6 months after the conclusion of the running group.
|
|
Kessler Psychological Distress Scale (K-10)
Délai: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
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Ten-item self-report measure of global psychological distress
|
Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
PTSD Checklist for DSM-V (PCL-5)
Délai: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
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Twenty-item self-report measure of PTSD based on the DSM-V diagnostic criteria
|
Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
|
|
Rosenberg Self-Esteem Scale (RSES)
Délai: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
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Ten-item self-report measure of global feelings of self-worth
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Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
|
|
Multidimensional Scale of Perceived Social Support
Délai: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
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Twelve-item self-report measure of perceived support from three sources: Family, friends, and a significant other
|
Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
|
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Work and Social Adjustment Scale (WSAS)
Délai: Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
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Five-item self-report measure of impairment in functioning
|
Starting 1 month to 2 weeks prior to group. Administered on a 4-week schedule ending 6 months after the conclusion of the running group.
|
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Physical Activity and Sleep
Délai: Starting 1 month to 2 weeks prior to group auto-recorded ending 6 months after the conclusion of the running group.
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Participants will use a Fitbit to monitor their overall activity (e.g., steps, distance, active minutes, etc.) and sleep patterns before, during, and after treatment
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Starting 1 month to 2 weeks prior to group auto-recorded ending 6 months after the conclusion of the running group.
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Delis-Kramer Executive Function Tower Task
Délai: At baseline and 1-week after exercise program ends.
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Assesses spatial planning, rule learning, and response inhibition
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At baseline and 1-week after exercise program ends.
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Hopkins Verbal Learning Task
Délai: At baseline and 1-week after exercise program ends.
|
Tests participants' memory for a list of 12 nouns drawn from 3 categories, and measures immediate and delayed recall and recognition
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At baseline and 1-week after exercise program ends.
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N-back
Délai: At baseline and 1-week after exercise program ends.
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A test of executive function (working memory), requiring the participant to observe a sequence of items and click on targets that are repeats n items ago
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At baseline and 1-week after exercise program ends.
|
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Concentration Memory Task
Délai: At baseline and 1-week after running program ends.
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A test of high interference spatial memory.
Participants search for pairs of matching cards and are periodically tested on which of two locations an item appeared in most recently
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At baseline and 1-week after running program ends.
|
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Town Square
Délai: At baseline and 1-week after running program ends.
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A test of viewpoint-dependent and -independent spatial memory for a set of visually presented items in a town square
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At baseline and 1-week after running program ends.
|
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Wechsler Test of Adult Reading
Délai: At baseline
|
A test to assess pre-morbid intellectual functioning by having the participants verbally speak a list of 50 irregular words
|
At baseline
|
Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Parrainer
Les enquêteurs
- Chercheur principal: Juliana Tobon, PhD, CPsych, St. Joseph's Research Institute - Youth Wellness Centre
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
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- Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
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- Blevins CA, Weathers FW, Davis MT, Witte TK, Domino JL. The Posttraumatic Stress Disorder Checklist for DSM-5 (PCL-5): Development and Initial Psychometric Evaluation. J Trauma Stress. 2015 Dec;28(6):489-98. doi: 10.1002/jts.22059. Epub 2015 Nov 25.
- Canty-Mitchell J, Zimet GD. Psychometric properties of the Multidimensional Scale of Perceived Social Support in urban adolescents. Am J Community Psychol. 2000 Jun;28(3):391-400. doi: 10.1023/A:1005109522457.
- RiskAnalytica. The life and economic impact of major mental illnesses in canada. Mental Health Commission of Canada. 2011:2011-2041.
- Lim KL, Jacobs P, Ohinmaa A, Schopflocher D, Dewa CS. A new population-based measure of the economic burden of mental illness in Canada. Chronic Dis Can. 2008;28(3):92-8.
- Merikangas KR, Nakamura EF, Kessler RC. Epidemiology of mental disorders in children and adolescents. Dialogues Clin Neurosci. 2009;11(1):7-20. doi: 10.31887/DCNS.2009.11.1/krmerikangas.
- Shapiro CM, Bortz R, Mitchell D, Bartel P, Jooste P. Slow-wave sleep: a recovery period after exercise. Science. 1981 Dec 11;214(4526):1253-4. doi: 10.1126/science.7302594.
- Dery N, Pilgrim M, Gibala M, Gillen J, Wojtowicz JM, Macqueen G, Becker S. Adult hippocampal neurogenesis reduces memory interference in humans: opposing effects of aerobic exercise and depression. Front Neurosci. 2013 Apr 30;7:66. doi: 10.3389/fnins.2013.00066. eCollection 2013.
- Anderson RJ, Brice S. The mood-enhancing benefits of exercise: Memory biases augment the effect. Psychology of Sport & Exercise. 2011;12(2):79-82. doi: 10.1016/j.psychsport.2010.08.003.
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- Prakash RS, Voss MW, Erickson KI, Lewis JM, Chaddock L, Malkowski E, Alves H, Kim J, Szabo A, White SM, Wojcicki TR, Klamm EL, McAuley E, Kramer AF. Cardiorespiratory fitness and attentional control in the aging brain. Front Hum Neurosci. 2011 Jan 14;4:229. doi: 10.3389/fnhum.2010.00229. eCollection 2011.
- Chang YK, Pesce C, Chiang YT, Kuo CY, Fong DY. Antecedent acute cycling exercise affects attention control: an ERP study using attention network test. Front Hum Neurosci. 2015 Apr 9;9:156. doi: 10.3389/fnhum.2015.00156. eCollection 2015.
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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)
31 janvier 2017
Achèvement primaire (Réel)
30 novembre 2018
Achèvement de l'étude (Réel)
30 novembre 2018
Dates d'inscription aux études
Première soumission
28 avril 2017
Première soumission répondant aux critères de contrôle qualité
3 mai 2017
Première publication (Réel)
8 mai 2017
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
21 avril 2020
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 avril 2020
Dernière vérification
1 avril 2020
Plus d'information
Termes liés à cette étude
Autres numéros d'identification d'étude
- 2785
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
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