Exercise Training in Depressed Traumatic Brain Injury Survivors
perjantai 18. joulukuuta 2015 päivittänyt: 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.
Tutkimuksen yleiskatsaus
Tila
Peruutettu
Interventio / Hoito
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Interventio
Vaihe
- Ei sovellettavissa
Yhteystiedot ja paikat
Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.
Opiskelupaikat
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Virginia
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Richmond, Virginia, Yhdysvallat, 23298-0568
- Virginia Commonwealth University
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Osallistumiskriteerit
Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.
Kelpoisuusvaatimukset
Opintokelpoiset iät
14 vuotta - 65 vuotta (Lapsi, Aikuinen, Vanhempi Aikuinen)
Hyväksyy terveitä vapaaehtoisia
Ei
Sukupuolet, jotka voivat opiskella
Kaikki
Kuvaus
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
Opintosuunnitelma
Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Yksittäinen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
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Placebo Comparator: 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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Active Comparator: 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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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completion of exercise protocol
Aikaikkuna: 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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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
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neuropsychological testing
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Täältä löydät tähän tutkimukseen osallistuvat ihmiset ja organisaatiot.
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Anne Hudak, MD, Virginia Commonwealth University
Julkaisuja ja hyödyllisiä linkkejä
Tutkimusta koskevien tietojen syöttämisestä vastaava henkilö toimittaa nämä julkaisut vapaaehtoisesti. Nämä voivat koskea mitä tahansa tutkimukseen liittyvää.
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