Exercise Training in Depressed Traumatic Brain Injury Survivors
18. desember 2015 oppdatert av: 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.
Studieoversikt
Status
Tilbaketrukket
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Intervensjonell
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
Virginia
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Richmond, Virginia, Forente stater, 23298-0568
- Virginia Commonwealth University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
14 år til 65 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Placebo komparator: 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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Aktiv komparator: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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completion of exercise protocol
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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neuropsychological testing
Tidsramme: pre and post intervention, week zero and week 13
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Anne Hudak, MD, Virginia Commonwealth University
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
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Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. februar 2013
Primær fullføring (Faktiske)
1. juni 2014
Studiet fullført (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først innsendt
1. mars 2013
Først innsendt som oppfylte QC-kriteriene
4. mars 2013
Først lagt ut (Anslag)
6. mars 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. desember 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
18. desember 2015
Sist bekreftet
1. desember 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- PT107574
- 7K23HD067553 (U.S. NIH-stipend/kontrakt)
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
produkt produsert i og eksportert fra USA
Nei
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