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Exercise Training in Depressed Traumatic Brain Injury Survivors

18. december 2015 opdateret af: 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.

Studieoversigt

Status

Trukket tilbage

Betingelser

Intervention / Behandling

Detaljeret 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.

Undersøgelsestype

Interventionel

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Forenede Stater
    • Virginia
      • Richmond, Virginia, Forenede Stater, 23298-0568
        • Virginia Commonwealth University

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år til 65 år (Barn, Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
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.
Andet: stretching and flexibility program
stretching and flexibility program for the Placebo Comparator Arm
Aktiv komparator: aerobic exercise group
aerobic activity targeting 60% peak heart rate for 12 weeks is the active group.
Andet: aerobic exercise
the active arm will be asked to perform 60% of maximum heart rate

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
completion of exercise protocol
Tidsramme: 12 weeks
The primary aim is to measure the rate of completion of the exercise protocol.
12 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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.
pre and post intervention, week zero and week 13
mood assessment
Tidsramme: week 0, week 13, and weekly during 12 week intervention
depression symptom inventories will be performed to examine the impact of exercise on cognition in depressed traumatic brain injury subjects. Administered to both arms.
week 0, week 13, and weekly during 12 week intervention
Columbia-Suicide Severity Rating Scale
Tidsramme: week 0, week 13, and weekly during 12 week intervention
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.
week 0, week 13, and weekly during 12 week intervention
magnetic resonance imaging
Tidsramme: week 0, week 13
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.
week 0, week 13
biochemical assays
Tidsramme: week 0, week 13
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.
week 0, week 13

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Virginia Commonwealth University

Samarbejdspartnere

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Efterforskere

  • Ledende efterforsker: Anne Hudak, MD, Virginia Commonwealth University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. februar 2013

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

1. marts 2013

Først indsendt, der opfyldte QC-kriterier

4. marts 2013

Først opslået (Skøn)

6. marts 2013

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

21. december 2015

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

18. december 2015

Sidst verificeret

1. december 2015

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • PT107574
  • 7K23HD067553 (U.S. NIH-bevilling/kontrakt)

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Depression

Kliniske forsøg med stretching and flexibility program

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

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Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

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