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临床试验/NCT00338832
NCT00338832已完成3 期

Adapting a Physical Activity Intervention for Schizophrenia

Veterans Medical Research Foundation2 个研究点 分布在 1 个国家目标入组 86 人开始时间: 2006年6月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
86
试验地点
2
主要终点
Frequency and intensity of PA

研究概览

简要总结

This study will evaluate the effectiveness of a lifestyle intervention in increasing physical activity and reducing disease symptoms in sedentary adults with schizophrenia.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
21 Years 至 64 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • Inability to complete assessments
  • Medical conditions that may make increasing physical activity unsafe
  • Currently participating in regular moderate to vigorous physical activity (defined as more than 150 minutes per week)

结局指标

主要结局

Frequency and intensity of PA

时间窗: Measured at baseline and Months 2, 6, and 8

次要结局

  • Quality of life(Measured at baseline and Months 2, 6, and 8)
  • Body mass index (BMI)(Measured at Months 2, 6, and 8)
  • Blood pressure(Measured at baseline and Months 2, 6, and 8)

研究者

发起方
Veterans Medical Research Foundation
申办方类型
Other
责任方
Principal Investigator
主要研究者

Laurie A. Lindamer

Research Scientist

Veterans Medical Research Foundation

研究点 (2)

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