Exercise Training in Depressed Traumatic Brain Injury Survivors
18 dicembre 2015 aggiornato da: 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.
Panoramica dello studio
Stato
Ritirato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Interventistico
Fase
- Non applicabile
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Luoghi di studio
-
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Virginia
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Richmond, Virginia, Stati Uniti, 23298-0568
- Virginia Commonwealth University
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
Da 14 anni a 65 anni (Bambino, Adulto, Adulto più anziano)
Accetta volontari sani
No
Sessi ammissibili allo studio
Tutto
Descrizione
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
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Comparatore 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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Comparatore attivo: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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completion of exercise protocol
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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neuropsychological testing
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Anne Hudak, MD, Virginia Commonwealth University
Pubblicazioni e link utili
La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.
Pubblicazioni generali
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Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio
1 febbraio 2013
Completamento primario (Effettivo)
1 giugno 2014
Completamento dello studio (Effettivo)
1 giugno 2014
Date di iscrizione allo studio
Primo inviato
1 marzo 2013
Primo inviato che soddisfa i criteri di controllo qualità
4 marzo 2013
Primo Inserito (Stima)
6 marzo 2013
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
21 dicembre 2015
Ultimo aggiornamento inviato che soddisfa i criteri QC
18 dicembre 2015
Ultimo verificato
1 dicembre 2015
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- PT107574
- 7K23HD067553 (Sovvenzione/contratto NIH degli Stati Uniti)
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
prodotto fabbricato ed esportato dagli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .