- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Washington
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Seattle, Washington, 미국, 98195
- University of Washington
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: 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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다른: 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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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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Beck Depression Inventory
기간: 10 week
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10 week
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공동 작업자 및 조사자
수사관
- 수석 연구원: Kathleen R Bell, M.D., University of Washington
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
Aerobic exercise에 대한 임상 시험
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