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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Behavioral: Physically Ready for Invigorating Movement Every Day (PRIME); Behavioral: Program for Activity, Leisure Skills, and Socialization (PALSS)

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 Type: Interventional
• Enrollment (Actual): 86
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of California, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 64 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1; Participants will receive the Physically Ready for Invigorating Movement Every Day program	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.
Active Comparator: 2; Participants will receive the Program for Activity, Leisure Skills, and Socialization	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency and intensity of PA	Measured at baseline and Months 2, 6, and 8

Secondary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Veterans Medical Research Foundation
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Laurie Lindamer, PhD, University of California, San Diego

Study record dates

Study Major Dates

• Study Start: June 1, 2006
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): August 1, 2011

Study Registration Dates

• First Submitted: June 16, 2006
• First Submitted That Met QC Criteria: June 16, 2006
• First Posted (Estimate): June 20, 2006

Study Record Updates

• Last Update Posted (Estimate): August 9, 2013
• Last Update Submitted That Met QC Criteria: August 6, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Keywords: Schizoaffective Disorder; Lifestyle Intervention
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia
• Other Study ID Numbers: R34MH071539 (U.S. NIH Grant/Contract); DAHBR 96-BHB