- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef 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.
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Washington
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Seattle, Washington, Verenigde Staten, 98195
- University of Washington
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Ander: 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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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Beck Depression Inventory
Tijdsspanne: 10 week
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10 week
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Kathleen R Bell, M.D., University of Washington
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 22868-B
- H133A020508
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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