NCT00338832

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
86

participants targeted

Target at below P25 for phase_3 schizophrenia

Timeline
Completed

Started Jun 2006

Longer than P75 for phase_3 schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2006

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
5.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 9, 2013

Status Verified

August 1, 2013

Enrollment Period

5.2 years

First QC Date

June 16, 2006

Last Update Submit

August 6, 2013

Conditions

Schizophrenia

Keywords

Lifestyle InterventionSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Frequency and intensity of PA

    Measured at baseline and Months 2, 6, and 8

Secondary Outcomes (3)

  • 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

Study Arms (2)

1

EXPERIMENTAL

Participants will receive the Physically Ready for Invigorating Movement Every Day program

Behavioral: Physically Ready for Invigorating Movement Every Day (PRIME)

2

ACTIVE COMPARATOR

Participants will receive the Program for Activity, Leisure Skills, and Socialization

Behavioral: Program for Activity, Leisure Skills, and Socialization (PALSS)

Interventions

Physically Ready for Invigorating Movement Every Day (PRIME)BEHAVIORAL

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.

1
Program for Activity, Leisure Skills, and Socialization (PALSS)BEHAVIORAL

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.

2

Eligibility Criteria

Age21 Years - 64 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

La Jolla, California, 92093, United States

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Exercise

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Laurie Lindamer, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Scientist

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

June 1, 2006

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 9, 2013

Record last verified: 2013-08

Locations

US(1)