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Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia

This study is currently recruiting participants.
Study NCT00338832.   Last updated on August 27, 2008.   Information provided by National Institute of Mental Health (NIMH)

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Descriptive Information Fields
Brief Title  Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia
Official Title  Adapting a Physical Activity Intervention for Schizophrenia
Brief Summary

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

Detailed Description

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.

Study Phase Phase III
Study Type  Interventional
Study Design  Treatment, Randomized, Single Blind (Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study
Primary Outcome Measure  Frequency and intensity of PA [ Time Frame: Measured at baseline and Months 2, 6, and 8 ] [ Designated as safety issue: No ]
Secondary Outcome Measure  Quality of life [ Time Frame: Measured at baseline and Months 2, 6, and 8 ] [ Designated as safety issue: No ]
Body mass index (BMI) [ Time Frame: Measured at Months 2, 6, and 8 ] [ Designated as safety issue: No ]
Blood pressure [ Time Frame: Measured at baseline and Months 2, 6, and 8 ] [ Designated as safety issue: No ]
Condition  Schizophrenia
Intervention  Behavioral: Physically Ready for Invigorating Movement Every Day (PRIME)
Behavioral: Program for Activity, Leisure Skills, and Socialization (PALSS)
MEDLINE PMIDs
Links
Recruitment Information Fields
Recruitment Status  Recruiting
Enrollment  86
Start Date  June 2006
Completion Date December 2008
Eligibility Criteria 

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)
Gender Both
Ages 21 Years to 64 Years
Accepts Healthy Volunteers No
Contacts ††
Contact: Jorge Gutierrez     858-552-8585 ext 3262     jagutierrez@ucsd.edu    
Contact: Jody Delapena     858-552-8585 ext 2743     jodelapena@ucsd.edu    
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00338832
Organization ID R34 MH71539
Secondary IDs †† DAHBR 96-BHB
Study Sponsor  National Institute of Mental Health (NIMH)
Collaborators ††
Investigators 
Principal Investigator:     Laurie Lindamer, PhD     University of California, San Diego    
Information Provided By National Institute of Mental Health (NIMH)
Verification Date August 2008
First Received Date  June 16, 2006
Last Updated Date August 27, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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