- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT00571545
The Effect of Exercise on Mood After Traumatic Brain Injury
We proposed to examine the effect of an aerobic exercise intervention on depression in persons with Traumatic Brain Injury (TBI). We will compare persons with chronic brain injury who are assigned to receive the exercise intervention with those in the control group to determine the effect of exercise on levels of depression and specific symptoms related to depression including anxiety, pain, sleep, and cognition. In addition, the effect of exercise on activity, participation level, and quality of life will be examined.
HYPOTHESES:
- Participation in an aerobic exercise intervention will decrease the severity of depression in persons with chronic TBI.
- Participation in an aerobic exercise intervention will lead to improvements in negative symptoms associated with depression including anxiety, insomnia, pain, and impaired cognitive functioning.
- Participation in an aerobic exercise intervention will be related to improvements in activity and participation for patients with TBI.
- Participation in an aerobic exercise intervention will lead to improvements in perceptions of quality of life.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Washington
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Seattle, Washington, Forente stater, 98195
- University of Washington
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- Traumatic brain injury 1-5 years prior to enrollment
- Current depression as measured by a score of 5 or greater on the depression portion of the Physician Health Questionnaire (PHQ).
- Sufficient cognitive ability to maintain participation in the study
- Sufficient English language ability to allow participation without an interpreter
Exclusion Criteria:
- Current suicidal ideation with intent or plan
- Currently pregnant
- History of significant cardiovascular or respiratory disease
- History of significant cardiovascular or respiratory disease
- Physical barriers to the use of standard aerobic exercise equipment
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
---|---|
Eksperimentell: 1
Subjects recruited from the community with a history of traumatic brain injury were enrolled into a 10 week supervised exercise program and encouraged to exercise at home as well.
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A supervised aerobic exercise program occurred weekly for 30 minutes with a 15 minute warm-up and a 15 minute cool down.
A half hour educational session on aspects of exercise and overcoming barriers to exercise was also instituted.
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Annen: 2
Controls were wait-listed for the supervised exercise program but were not treated during the 10 week wait period.
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Controls were wait-listed for the exercise program during the 10 week study period.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
---|---|
Beck Depression Inventory
Tidsramme: 10 week
|
10 week
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Kathleen R Bell, M.D., University of Washington
Publikasjoner og nyttige lenker
Studierekorddatoer
Studer hoveddatoer
Studiestart
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 22868-B
- H133A020508
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