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Exercise and Rehabilitation After Traumatic Brain Injury

26. januar 2018 opdateret af: Grace S. Griesbach, Centre for Neuro Skills

Effects of Aerobic Exercise and Rehabilitation After Traumatic Brain Injury

The purpose of this study is to examine the effects of exercise on recovery after traumatic brain injury. Investigators will determine if exercise enhances rehabilitation by increasing substances (proteins) that can facilitate recovery.

Studieoversigt

Status

Ukendt

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Exercise-based therapies can promote recovery of function and are easily implemented in the clinical rehabilitation setting. This study will determine if exercise facilitates recovery by improving markers of neuroplasticity and decreasing neuroinflammatory responses. The investigators will also determine if variations in genes involved in neuroplasticity, memory and inflammation influence the responsiveness to exercise and rehabilitation. Particular genetic polymorphisms involved in neuroplasticity and inflammatory responses will be evaluated. Recovery will be determined by assessing cognitive function, life quality and balance.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

120

Fase

  • Fase 1

Kontakter og lokationer

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

Studiesteder

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

18 år til 60 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion Criteria:

  • Clinical diagnosis of TBI (for R+AER and R groups).
  • Fluency in English or Spanish.
  • Able to walk with or without a device.

Exclusion Criteria:

  • Orthopedic or cardiac conditions that prevent from exercising.
  • Current diagnosis of neurological and/or psychiatric diseases.

Unable to be in the Los Angeles CA metropolitan area for the duration of the study

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Intervention aerobic exercise (AER)
Participants with traumatic brain injury (TBI) that are enrolled in a comprehensive rehabilitation program (R) will be engaged in an aerobic exercise program (AER). These participants will also receive standard rehabilitation which includes exercise within the physical therapy session. Given that the duration of the rehabilitative program is variable the period of AER training will be no less than 4 weeks and will not exceed 30 weeks. Activity levels will be monitored.
Andet: Aerobic Exercise (AER)
Aerobic exercise will be performed with a treadmill or stationary tandem bike 3 times per week. Each exercise session will take about 30 minutes plus 5 to 10 min of warm-up and cool-down. Participants will wear a safety harness.
Andet: Rehabilitering
Rehabiliteringsprogram er fokuseret på afslutning af aktiviteter i dagligdagen, igangsættelse, passende adfærd og samfundsintegration i fem dage om ugen på Center for Neurofærdigheder.
Aktiv komparator: rehabilitation (R)
Participants with traumatic brain injury that are enrolled in a comprehensive rehabilitation program. These participants will receive standard rehabilitation. Given that the duration of the rehabilitative program is variable the duration of participation will be no less than 4 weeks and will not exceed 30 weeks. Activity levels will be monitored.
Andet: Rehabilitering
Rehabiliteringsprogram er fokuseret på afslutning af aktiviteter i dagligdagen, igangsættelse, passende adfærd og samfundsintegration i fem dage om ugen på Center for Neurofærdigheder.
Ingen indgriben: control (C)
Healthy volunteers' responsiveness to exercise and activity levels will be determined to detect TBI effects.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Aerobic Exercise Induced Changes in Inflammatory responses to exercise
Tidsramme: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Selected analytes will be evaluated from serum.
4 to 30 weeks depending on the duration of rehabilitation coverage.
Aerobic Exercise Induced Changes in Cognitive Function
Tidsramme: 5 years
Attention, processing speed, reaction times, memory and nonverbal reasoning are evaluated by CNS Vital Signs. All scores are aggregated to one reported value (Neurocognitive Index). Scoring is by a computer based auto-scored multivariate scoring system developed by the manufacturers.
5 years
Aerobic Exercise Induced Changes in Cardio Pulmonary Fitness
Tidsramme: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Ventilatory Threshold (aerobic capacity)
4 to 30 weeks depending on the duration of rehabilitation coverage.
Aerobic Exercise Induced Changes in Neuroplasticity responses to exercise
Tidsramme: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Selected analytes will be evaluated from serum.
4 to 30 weeks depending on the duration of rehabilitation coverage.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Genetic polymorphisms involved in Inflammatory and neuroplasticity responses to aerobic exercise.
Tidsramme: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Genetic material will be obtained.
4 to 30 weeks depending on the duration of rehabilitation coverage.
Aerobic Exercise Induced Changes in Depression Symptoms
Tidsramme: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Beck Depression Inventory
4 to 30 weeks depending on the duration of rehabilitation coverage.

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Verbal Memory
Tidsramme: 4 to 30 weeks depending on the duration of rehabilitation coverage.
California Verbal Learning Test (CVLT II).
4 to 30 weeks depending on the duration of rehabilitation coverage.
Visual Search/Processing Speed
Tidsramme: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Trail Making
4 to 30 weeks depending on the duration of rehabilitation coverage.
Quality of Life
Tidsramme: 4 to 30 weeks depending on the duration of rehabilitation coverage.
Quality of Life in Neurological Disorders (Neuro-QoL)
4 to 30 weeks depending on the duration of rehabilitation coverage.

Samarbejdspartnere og efterforskere

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

Sponsor

Centre for Neuro Skills

Efterforskere

  • Ledende efterforsker: Grace S Griesbach, PhD, Centre for Neuro Skills

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

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. juni 2016

Primær færdiggørelse (Forventet)

1. marts 2020

Studieafslutning (Forventet)

1. marts 2022

Datoer for studieregistrering

Først indsendt

9. juli 2015

Først indsendt, der opfyldte QC-kriterier

16. januar 2018

Først opslået (Faktiske)

23. januar 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. januar 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

26. januar 2018

Sidst verificeret

1. januar 2018

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • AER-TBI1

Plan for individuelle deltagerdata (IPD)

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Kliniske forsøg med Traumatisk hjerneskade

Kliniske forsøg med Aerobic Exercise (AER)

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