- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT00338832
Effectiveness of a Lifestyle Intervention for Increasing Physical Activity in Adults With Schizophrenia
Adapting a Physical Activity Intervention for Schizophrenia
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Fase 3
Contatti e Sedi
Luoghi di studio
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California
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La Jolla, California, Stati Uniti, 92093
- University of California, San Diego
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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)
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
|
|
Comparatore attivo: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
|---|---|
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Frequency and intensity of PA
Lasso di tempo: Measured at baseline and Months 2, 6, and 8
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Measured at baseline and Months 2, 6, and 8
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Misure di risultato secondarie
Misura del risultato |
Lasso di tempo |
|---|---|
|
Quality of life
Lasso di tempo: Measured at baseline and Months 2, 6, and 8
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Measured at baseline and Months 2, 6, and 8
|
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Body mass index (BMI)
Lasso di tempo: Measured at Months 2, 6, and 8
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Measured at Months 2, 6, and 8
|
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Blood pressure
Lasso di tempo: Measured at baseline and Months 2, 6, and 8
|
Measured at baseline and Months 2, 6, and 8
|
Collaboratori e investigatori
Collaboratori
Investigatori
- Investigatore principale: Laurie Lindamer, PhD, University of California, San Diego
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- R34MH071539 (Sovvenzione/contratto NIH degli Stati Uniti)
- DAHBR 96-BHB
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .