Exercise Training in Depressed Traumatic Brain Injury Survivors
18 décembre 2015 mis à jour par: Virginia Commonwealth University
The purpose of this study is to determine the feasibility of successfully delivering moderate intensity aerobic exercise training to depressed traumatic brain injury subjects between one and three years after injury.
Aperçu de l'étude
Statut
Retiré
Les conditions
Intervention / Traitement
Description détaillée
Traumatic brain injury (TBI) alters the lives of many civilians and those involved in armed conflicts.
Sequelae of TBI includes depression in up to 30% of cases.
Appearance of depression after TBI impairs recovery and results in sub-optimal re-integration into society.
Treatment of post TBI depression relies on oral medications, whose efficacy and side effect profile is sub-optimal.
Exercise training is effective in spontaneous depression as a stand alone treatment and in conjunction with oral medications, and this may represent an alternative treatment option in the TBI population.
Further, the pathophysiology of depression after TBI has yet to be examined with the full scientific rigor required.
This project proposes to use exercise training of moderate intensity as a treatment for depression after TBI, while measuring biological markers as a way to investigate efficacy and provide insight into the pathophysiology.
Type d'étude
Interventionnel
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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Virginia
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Richmond, Virginia, États-Unis, 23298-0568
- Virginia Commonwealth 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
14 ans à 65 ans (Enfant, Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
Inclusion Criteria:
- CT brain with subdural hematoma, subarachnoid hemorrhage, and/or cortical contusion
- Glasgow outcome scale extended of 4 to 8
- speaks English
- Beck Depression Inventory -II score between 14 and 28
- sedentary life style
- one to three years after traumatic brain injury
Exclusion Criteria:
- prior history of brain process (example, stroke, brain tumor)
- aphasia
- psychosis, mania, bipolar disorder, schizophrenia
- pregnancy
- inability to exercise via cycles or treadmill
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
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Comparateur placebo: stretching-flexibility
This group will use a stretching and flexibility program designed to utilize minimal levels of aerobic capacity.
It was chosen in place of a education-based control group due to the high level of personal interaction that is found in the active arm.
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stretching and flexibility program for the Placebo Comparator Arm
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Comparateur actif: aerobic exercise group
aerobic activity targeting 60% peak heart rate for 12 weeks is the active group.
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the active arm will be asked to perform 60% of maximum heart rate
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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completion of exercise protocol
Délai: 12 weeks
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The primary aim is to measure the rate of completion of the exercise protocol.
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12 weeks
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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neuropsychological testing
Délai: pre and post intervention, week zero and week 13
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cognitive testing battery will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects.
Administered to both arms.
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pre and post intervention, week zero and week 13
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mood assessment
Délai: week 0, week 13, and weekly during 12 week intervention
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depression symptom inventories will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects.
Administered to both arms.
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week 0, week 13, and weekly during 12 week intervention
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Columbia-Suicide Severity Rating Scale
Délai: week 0, week 13, and weekly during 12 week intervention
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Columbia-Suicide Severity Rating Scale was developed to meet the need for tracking changes in a person's suicidal thinking and behavior over time, and to determine who is most at risk.
Administered to both arms.
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week 0, week 13, and weekly during 12 week intervention
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magnetic resonance imaging
Délai: week 0, week 13
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MRI will be done before and after exercise protocol on a subset of subjects.
Selection of these subjects will be done by randomization, starting once the MRI is available for use.
The purpose is to examine the brain for exercise influenced volumetric changes.
Administered to a subset of both arms of the study.
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week 0, week 13
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biochemical assays
Délai: week 0, week 13
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brain-derived neurotrophic factor, vascular endothelial growth factor, insulin-like growth factor-1.
The listed neurotrophic factors have been linked to depression and have been shown to be influenced by exercise.
The impact of depression and exercise in the context of traumatic brain injury is unknown.
Administered to both study arms.
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week 0, week 13
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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: Anne Hudak, MD, Virginia Commonwealth 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.
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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
1 février 2013
Achèvement primaire (Réel)
1 juin 2014
Achèvement de l'étude (Réel)
1 juin 2014
Dates d'inscription aux études
Première soumission
1 mars 2013
Première soumission répondant aux critères de contrôle qualité
4 mars 2013
Première publication (Estimation)
6 mars 2013
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
21 décembre 2015
Dernière mise à jour soumise répondant aux critères de contrôle qualité
18 décembre 2015
Dernière vérification
1 décembre 2015
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- PT107574
- 7K23HD067553 (Subvention/contrat des NIH des États-Unis)
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
produit fabriqué et exporté des États-Unis.
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 .