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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Laurie A. Lindamer, Veterans Medical Research Foundation
ClinicalTrials.gov Identifier:
NCT00338832
First received: June 16, 2006
Last updated: August 6, 2013
Last verified: August 2013

June 16, 2006
August 6, 2013
June 2006
August 2011   (final data collection date for primary outcome measure)
Frequency and intensity of PA [ Time Frame: Measured at baseline and Months 2, 6, and 8 ] [ Designated as safety issue: No ]
Measured at Months 6 and 8: Frequency of PA
Complete list of historical versions of study NCT00338832 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Measured at Months 6 and 8: Quality of life
  • Body mass index (BMI)
  • Blood pressure
Not Provided
Not Provided
 
Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia
Adapting a Physical Activity Intervention for Schizophrenia

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

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Schizophrenia
  • Behavioral: Physically Ready for Invigorating Movement Every Day (PRIME)
    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.
  • Behavioral: Program for Activity, Leisure Skills, and Socialization (PALSS)
    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.
  • Experimental: 1
    Participants will receive the Physically Ready for Invigorating Movement Every Day program
    Intervention: Behavioral: Physically Ready for Invigorating Movement Every Day (PRIME)
  • Active Comparator: 2
    Participants will receive the Program for Activity, Leisure Skills, and Socialization
    Intervention: Behavioral: Program for Activity, Leisure Skills, and Socialization (PALSS)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
August 2011
August 2011   (final data collection date for primary outcome measure)

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)
Both
21 Years to 64 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00338832
R34 MH071539, R34MH071539, DAHBR 96-BHB
Yes
Laurie A. Lindamer, Veterans Medical Research Foundation
Veterans Medical Research Foundation
National Institute of Mental Health (NIMH)
Principal Investigator: Laurie Lindamer, PhD University of California, San Diego
Veterans Medical Research Foundation
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP