- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT00338832
Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia
Adapting a Physical Activity Intervention for Schizophrenia
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
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.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Phase 3
Kontakte und Standorte
Studienorte
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California
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La Jolla, California, Vereinigte Staaten, 92093
- University of California, San Diego
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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)
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Experimental: 1
Participants will receive the Physically Ready for Invigorating Movement Every Day program
|
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.
|
Aktiver Komparator: 2
Participants will receive the Program for Activity, Leisure Skills, and Socialization
|
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.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Frequency and intensity of PA
Zeitfenster: Measured at baseline and Months 2, 6, and 8
|
Measured at baseline and Months 2, 6, and 8
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
---|---|
Quality of life
Zeitfenster: Measured at baseline and Months 2, 6, and 8
|
Measured at baseline and Months 2, 6, and 8
|
Body mass index (BMI)
Zeitfenster: Measured at Months 2, 6, and 8
|
Measured at Months 2, 6, and 8
|
Blood pressure
Zeitfenster: Measured at baseline and Months 2, 6, and 8
|
Measured at baseline and Months 2, 6, and 8
|
Mitarbeiter und Ermittler
Mitarbeiter
Ermittler
- Hauptermittler: Laurie Lindamer, PhD, University of California, San Diego
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- R34MH071539 (US NIH Stipendium/Vertrag)
- DAHBR 96-BHB
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