- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00338832
Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia
Adapting a Physical Activity Intervention for Schizophrenia
연구 개요
상태
정황
상세 설명
Schizophrenia is a severely disabling brain disorder. People with schizophrenia often experience hallucinations, delusions, thought disorders, and movement disorders. Physical activity (PA) has been shown not only to increase quality of life, but also to reduce risk factors for several chronic diseases and conditions. The majority of adults, however, do not engage in the recommended amount of PA. Research has shown that people with schizophrenia are even less likely to be regularly physically active. Symptoms of schizophrenia, pharmacological treatments for the disease, and the lifestyle associated with the disease tend to contribute to physical inactivity and the resulting complications. Effective interventions to increase PA have been developed for the general adult population, but very little is known about how to adapt them for use in adults with schizophrenia. The PRIME (Physically Ready for Invigorating Movement Every Day) program is a lifestyle intervention focused on increasing physical activity. This study will evaluate the effectiveness of a modified PRIME program in reducing the risk for morbidity in sedentary adults with schizophrenia.
Participants in this 24-week, single-blind study will be randomly assigned to either the PRIME intervention group or the comparison group, which will involve the Program for Activity, Leisure Skills, and Socialization (PALSS). All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks. PRIME sessions will focus on learning about PA, setting PA-related goals, and assessing short- and long-term goals. Goals may include early-stage process-oriented goals, such as reading about PA benefits or finding a walking partner. Goals tailored to later stages of change include explicit PA goals, such as increasing frequency, duration, and intensity of PA. Training will also be accomplished online and via printed material. PALSS sessions will focus on motivating participants to engage in leisure and social activity. Sessions will include interactive, structured activity that will be led by a therapist, as well as unstructured leisure activities, such as board games, cards, general socialization, and viewing a travel video. Social and communication skills will not be explicitly taught or practiced. All participants will attend study visits at Months 2, 6, and 8 to assess outcomes. A follow-up visit will be held 2 months post-intervention.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
California
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La Jolla, California, 미국, 92093
- University of California, San Diego
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Speaks English
- Diagnosis of schizophrenia or schizoaffective disorder
- Currently living in a residential facility
- Currently receiving outpatient care
- Medical clearance
- Willing to sign a release of medical information
Exclusion Criteria:
- Inability to complete assessments
- Medical conditions that may make increasing physical activity unsafe
- Pregnant
- Currently participating in regular moderate to vigorous physical activity (defined as more than 150 minutes per week)
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 |
|---|---|
|
실험적: 1
Participants will receive the Physically Ready for Invigorating Movement Every Day program
|
The PRIME program is a lifestyle intervention focused on increasing physical activity.
The intervention is cognitive/behaviorally based, 24-weeks in length, and a lifestyle PA intervention known to be effective in the general population of adults.
The program has been modified based on theory and empirical findings about this special subgroup.
All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks.
PRIME sessions will focus on learning about PA, setting PA-related goals, and assessing short- and long-term goals.
Goals may include early-stage process-oriented goals, such as reading about PA benefits or finding a walking partner.
|
|
활성 비교기: 2
Participants will receive the Program for Activity, Leisure Skills, and Socialization
|
PALSS sessions will focus on motivating participants to engage in leisure and social activity.
Sessions will include interactive, structured activity that will be led by a therapist, as well as unstructured leisure activities, such as board games, cards, general socialization, and viewing a travel video.
Social and communication skills will not be explicitly taught or practiced.
All participants will attend 90-minute sessions weekly for the first 16 weeks, then biweekly for the remaining 8 weeks.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
|
Frequency and intensity of PA
기간: Measured at baseline and Months 2, 6, and 8
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Measured at baseline and Months 2, 6, and 8
|
2차 결과 측정
결과 측정 |
기간 |
|---|---|
|
Quality of life
기간: Measured at baseline and Months 2, 6, and 8
|
Measured at baseline and Months 2, 6, and 8
|
|
Body mass index (BMI)
기간: Measured at Months 2, 6, and 8
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Measured at Months 2, 6, and 8
|
|
Blood pressure
기간: Measured at baseline and Months 2, 6, and 8
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Measured at baseline and Months 2, 6, and 8
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Laurie Lindamer, PhD, University of California, San Diego
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
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 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- R34MH071539 (미국 NIH 보조금/계약)
- DAHBR 96-BHB
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. .